Trial Outcomes & Findings for EASiVENT Study Comparing INTELLiVENT-ASV vs Non Automated Ventilation in Adult ICU Patients (NCT NCT04400643)

NCT ID: NCT04400643

Last Updated: 2024-10-23

Results Overview

Objective of this study is to compare the efficacy of the investigational automated ventilation (INTELLiVENT-ASV) with a control ventilation group (conventional non-automated ventilation) in ICU subjects. The hypothesis is that INTELLiVENT-ASV is better than conventional non-automated ventilation in terms of efficacy. Efficacy endpoints are composite endpoints \& are based on six variables that will be continuously recorded during the study period: These 6 variables: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure. Each breath was analyzed and the breath was considered as optimal when all six variables were within predefined optimal ranges

• Recruitment status: TERMINATED
• Target enrollment: 62 participants
• Primary outcome timeframe: up to 7 days after enrollment
• Results posted on: 2024-10-23

Participant Flow

Participant milestones

Measure	INTELLiVENT-ASV INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.	Non-Automated Ventilation In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.
Overall Study STARTED	31	31
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	Total n=62 Participants Total of all reporting groups
Age, Customized	64 years n=31 Participants	67 years n=31 Participants	65 years n=62 Participants
Sex: Female, Male Female	14 Participants n=31 Participants	13 Participants n=31 Participants	27 Participants n=62 Participants
Sex: Female, Male Male	17 Participants n=31 Participants	18 Participants n=31 Participants	35 Participants n=62 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: up to 7 days after enrollment

Objective of this study is to compare the efficacy of the investigational automated ventilation (INTELLiVENT-ASV) with a control ventilation group (conventional non-automated ventilation) in ICU subjects. The hypothesis is that INTELLiVENT-ASV is better than conventional non-automated ventilation in terms of efficacy. Efficacy endpoints are composite endpoints & are based on six variables that will be continuously recorded during the study period: These 6 variables: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure. Each breath was analyzed and the breath was considered as optimal when all six variables were within predefined optimal ranges

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Efficacy Measured as Percentage of Time Spent in Optimal Range	29 percentage of time in optimal ranges Interval 8.0 to 39.0	28 percentage of time in optimal ranges Interval 19.0 to 37.0

PRIMARY outcome

Timeframe: 7 days after enrollment.

Objective of this study is to compare the safety of the investigational automated ventilation (INTELLiVENT-ASV) with a control ventilation group (conventional non-automated ventilation) in ICU subjects. The hypothesis is that INTELLiVENT-ASV is better than conventional non-automated ventilation in terms of safety. Safety endpoints are composite endpoints & are based on six variables that will be continuously recorded during the study period: sub-optimal range: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure. Each breath was analyzed and the breath was considered as sub-optimal when at least one of the six variables was within predefined sub-optimal ranges.

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Safety Measured as Percentage of Time Spent in Sub-optimal Range	13 percentage of time in sub-optimal range Interval 8.0 to 19.0	16 percentage of time in sub-optimal range Interval 3.0 to 39.0

SECONDARY outcome

Timeframe: up to 28 days after enrollment

FiO2 was measured breath-by-breath for all the study periods.

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Fraction of Inspiration Oxygen (FiO2) (%)	36 percentage of inspired oxygen Interval 33.0 to 46.0	31 percentage of inspired oxygen Interval 27.0 to 38.0

SECONDARY outcome

Timeframe: up to 28 days after enrollment

Expiratory time constant was calculated breath-by-breath as the ratio of volume divided by flow at 75% of the expired volume.

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Expiratory Time Constant (s)	0.54 second (s) Interval 0.44 to 0.65	0.59 second (s) Interval 0.46 to 0.72

SECONDARY outcome

Timeframe: up to 28 days after enrollment

PEEP was measured breath-by-breath for all the study period.

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Positive End-Expiratory Pressure (PEEP) (cm H2O)	8.0 Cm H2O Interval 5.9 to 10.3	7.7 Cm H2O Interval 6.7 to 10.9

SECONDARY outcome

Timeframe: up to 28 days after enrollment

Tidal volume was measured breath-by-breath for all the study period.

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Tidal Volume (ml)	422 milliliter (ml) Interval 366.0 to 477.0	420 milliliter (ml) Interval 358.0 to 482.0

SECONDARY outcome

Timeframe: up to 28 days after enrollment

Tidal volume mL/kg ideal body weight (IBW) will be assessed automatically breath-by-breath

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Tidal Volume mL/kg Ideal Body Weight (IBW)	6.6 ml/kg of ideal body weight (IBW) Interval 5.9 to 7.1	6.8 ml/kg of ideal body weight (IBW) Interval 5.8 to 8.1

SECONDARY outcome

Timeframe: up to 28 days after enrollment

Respiratory rate was measured breath-by-breath for all the study period.

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Ventilation - Respiratory Rate	22 breath/min Interval 20.0 to 25.0	20 breath/min Interval 18.0 to 24.0

SECONDARY outcome

Timeframe: up to 28 days after enrollment

The total number of automatic setting changes was recorded during the study period. Automatic settings included inspiratory pressure, pressure support, respiratory rate, PEEP, and inspired oxygen fraction.

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Numbers of Manual Settings Changes Per Day	28 manual setting changes per day Interval 16.0 to 117.0	12 manual setting changes per day Interval 7.0 to 15.0

SECONDARY outcome

Timeframe: up to 28 days after enrollment

The total number of automatic setting changes was recorded during the study period. Automatic settings included inspiratory pressure, pressure support, respiratory rate, PEEP, and inspired oxygen fraction.

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Automatic Settings Changes Per Day	0 automatic setting changes per day Interval 0.0 to 0.0	1040 automatic setting changes per day Interval 511.0 to 1441.0

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 28 days after enrollment

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Mortality at 28 Days (n (%))	11 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 28 days from enrollment

Mechanical ventilation duration was recorded from the date of intubation to the date of last extubation or death if the patient died while still intubated.

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Duration Invasive Mechanical Ventilation (Days)	5.3 days Interval 3.9 to 9.9	4.7 days Interval 3.0 to 8.9

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 28 days from enrollment

Passive ventilation is defined when the percentage of subject's triggered breath is lower than 25% of total respiratory rate.

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Passive Ventilation Duration (h)	42 hours (h) Interval 6.0 to 92.0	52 hours (h) Interval 15.0 to 88.0

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 28 days from enrollment

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Ventilator Free Days at Day 28 (d)	18 days Interval 0.0 to 22.0	20 days Interval 0.0 to 24.0

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 28 days after enrollment

The percentage of time in the allocated mode was calculated breath-by-breath according to the ventilation mode used.

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Percentage of Time in Allocated Mode (%)	100 percentage Interval 100.0 to 100.0	100 percentage Interval 99.0 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 28 days from enrollment

Percentage of time spent in optimal range was calculated breath-by-breath during all the study period. Breath were classified as optimal when all six variables were in predefined optimal range: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure.

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Efficacy Measured as Percentage of Time Spent in Optimal Range	27 percentage of time in optimal ranges Interval 8.0 to 59.0	22 percentage of time in optimal ranges Interval 7.0 to 49.0

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 28 days from enrollment

Percentage of time spent in sub-optimal range was calculated breath-by-breath during all the study period. Breath were classified as sub-optimal when at least one variable was in predefined sub-optimal range: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure.

Outcome measures

Measure	Non-Automated Ventilation n=31 Participants In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	INTELLiVENT-ASV n=31 Participants INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Safety Measured as Percentage of Time Spent in Sub-optimal Range	21 percentage of time in sub-optimal ranges Interval 6.0 to 45.0	30 percentage of time in sub-optimal ranges Interval 9.0 to 65.0

Adverse Events

INTELLiVENT-ASV

Serious events: 6 serious events

Other events: 2 other events

Deaths: 7 deaths

Non-Automated Ventilation

Serious events: 5 serious events

Other events: 4 other events

Deaths: 11 deaths

Serious adverse events

Measure	INTELLiVENT-ASV n=31 participants at risk INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.	Non-Automated Ventilation n=31 participants at risk In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.
Injury, poisoning and procedural complications ACCIDENTAL EXTUBATION BY THE PATIENT	3.2% 1/31 • Number of events 1 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module
Cardiac disorders Asystole	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	9.7% 3/31 • Number of events 3 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module
Gastrointestinal disorders Cecum perforation	3.2% 1/31 • Number of events 1 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module
Cardiac disorders HEMODYNAMIC INSTABILITY IN THE CONTEXT OF DISTRIBUTIVE SHOCK (REASON FOR ADMISSION	3.2% 1/31 • Number of events 1 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module
Surgical and medical procedures STUDY PRINCIPAL INVESTIGATOR DECIDES TO CHANGE THE VENTILATION MODE ALLOCATED BY RANDOMIZATION	3.2% 1/31 • Number of events 1 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module
Nervous system disorders HYPOXIC BRAIN INJURY	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	3.2% 1/31 • Number of events 1 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module
Cardiac disorders HEMODYNAMIC INSTABILITY	3.2% 1/31 • Number of events 1 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module
Injury, poisoning and procedural complications SIGNIFICANT HYPOXEMIA	3.2% 1/31 • Number of events 1 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module
Infections and infestations SUSPICION OF SEPSIS	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	3.2% 1/31 • Number of events 1 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module

Other adverse events

Measure	INTELLiVENT-ASV n=31 participants at risk INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.	Non-Automated Ventilation n=31 participants at risk In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.
Injury, poisoning and procedural complications Ventilator-associated pneumonia (VAP)	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	3.2% 1/31 • Number of events 1 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module
Injury, poisoning and procedural complications ATELECTASIS OF LEFT LUNG	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	3.2% 1/31 • Number of events 1 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module
Injury, poisoning and procedural complications DESOBSTRUCTION FIBROSCOPY	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	3.2% 1/31 • Number of events 1 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module
Injury, poisoning and procedural complications Barotrauma	3.2% 1/31 • Number of events 1 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module
Product Issues Faulty Spo2 Sensor	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	3.2% 1/31 • Number of events 1 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module
Injury, poisoning and procedural complications MULTIPLE PERIODS OF VENT DESYNCHRONY	3.2% 1/31 • Number of events 1 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module	0.00% 0/31 • up to 28 days after enrollment The study includes a general ICU patient population in need of mechanical ventilation for at least 24hrs. This population includes critically ill patients spanning a variety of primary and secondary medical conditions that can cause AEs including severe disability and death irrespective of study participation. All deaths, Serious Adverse Events, and Other Adverse Events that occurred in the study are reported in the Adverse Event module

Additional Information

Jean Michel Arnal

Hamilton Medical AG

Phone: +33 1 84 04 97 58

Email: jarnal@hamilton-medical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60