Trial Outcomes & Findings for Evaluating Air Leak Detection in Intubated Patients (NCT NCT01857986)

NCT ID: NCT01857986

Last Updated: 2017-06-19

Results Overview

Trial outcome measure represents patients' exposure to CO2 leakage standardized per hour. Specifically, each patients' area under the curve (AUC) of CO2 leakage (mmHg) is computed over the whole trial by multiplying leakage duration (X-axis; continuous time) by CO2 level (Y-axis; mmHg), divided by the patient's number of hours in the trial. Outcome measure is thus \[CO2 mmHg\*hour\]/hour. CO2 leakage is the concentration of CO2 above the cuff as measured by the AG100 system every few minutes (in clinical mode). Time points which created the curve were every two adjacent time intervals having a valid CO2 reading.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 76 participants
• Primary outcome timeframe: Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days
• Results posted on: 2017-06-19

Participant Flow

Participant milestones

Measure	Study Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.	Control Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
Overall Study STARTED	39	37
Overall Study COMPLETED	34	30
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating Air Leak Detection in Intubated Patients

Baseline characteristics by cohort

Measure	Study n=34 Participants Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.	Control n=30 Participants Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.	Total n=64 Participants Total of all reporting groups
Age, Continuous	65.0 years STANDARD_DEVIATION 18.8 • n=93 Participants	66.7 years STANDARD_DEVIATION 11.2 • n=4 Participants	65.8 years STANDARD_DEVIATION 15.6 • n=27 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	12 Participants n=4 Participants	23 Participants n=27 Participants
Sex: Female, Male Male	23 Participants n=93 Participants	18 Participants n=4 Participants	41 Participants n=27 Participants

PRIMARY outcome

Timeframe: Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days

Trial outcome measure represents patients' exposure to CO2 leakage standardized per hour. Specifically, each patients' area under the curve (AUC) of CO2 leakage (mmHg) is computed over the whole trial by multiplying leakage duration (X-axis; continuous time) by CO2 level (Y-axis; mmHg), divided by the patient's number of hours in the trial. Outcome measure is thus [CO2 mmHg*hour]/hour.

CO2 leakage is the concentration of CO2 above the cuff as measured by the AG100 system every few minutes (in clinical mode). Time points which created the curve were every two adjacent time intervals having a valid CO2 reading.

Outcome measures

Measure	Study n=34 Participants Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.	Control n=30 Participants Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
CO2 Leakage Above the ETT Cuff, Measured Over Time.	0.09 [CO2 mmHg*hour]/hour Standard Deviation 0.04	0.22 [CO2 mmHg*hour]/hour Standard Deviation 0.32

SECONDARY outcome

Timeframe: Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days

mean number of cuff pressure measurements within the safety accepted range of 24 and 40 cmH2O, normalized using the total number of valid cuff pressure measurements.

Outcome measures

Measure	Study n=34 Participants Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.	Control n=30 Participants Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
Number of the Cuff Pressure Measurements Within the Safety Accepted Range (24 and 40cmH2O)	0.979 normalized number of Cp measurements Standard Deviation 0.064	0.397 normalized number of Cp measurements Standard Deviation 0.302

POST_HOC outcome

Timeframe: Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days

Time (minutes) of CO2 leakage readings at or above 2 mmHg

Outcome measures

Measure	Study n=34 Participants Study patients were connected to the AnapnoGuard 100 system, using all functional modalities: active cuff pressure control, using subglottic CO2 readings as an indicator for leaks and automatic, periodic rinsing and suction of subglottic secretions.	Control n=30 Participants Control patients were connected to the AnapnoGuard 100 system, with automatic, periodical rinsing and suction of subglottic secretions, while the cuff pressure control was not active (turned OFF). In the control group, the system recorded the CO2 levels in the subglottic space, but cuff pressure was managed manually using a manometer 3 times daily.
Duration of Significant CO2 Leakage	4.61 minutes Standard Deviation 3.53	34.53 minutes Standard Deviation 83.27

Adverse Events

Study

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Control

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Study n=39 participants at risk	Control n=33 participants at risk
General disorders Death	7.7% 3/39 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.	9.1% 3/33 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.
General disorders Hemodynamic instability	0.00% 0/39 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.	3.0% 1/33 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.

Other adverse events

Measure	Study n=39 participants at risk	Control n=33 participants at risk
Cardiac disorders Atrial Fibrilation	2.6% 1/39 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.	6.1% 2/33 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.
Infections and infestations Infection of surgery wound	2.6% 1/39 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.	3.0% 1/33 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.
Gastrointestinal disorders Melena	0.00% 0/39 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.	3.0% 1/33 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.
Injury, poisoning and procedural complications Massive bleeding after surgery	0.00% 0/39 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.	3.0% 1/33 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.
Respiratory, thoracic and mediastinal disorders Pneumonia	12.8% 5/39 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.	9.1% 3/33 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.6% 1/39 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.	3.0% 1/33 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/39 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.	3.0% 1/33 Four patients enrolled into the Control group were not connected to the investigational system (i.e. the AnapnoGuard 100 system). For this reason, safety data was collected only for 33 patients and not for the total 37 patients who were enrolled into this group.

Additional Information

Clinical Trials Manager

Hospitech Respiration

Phone: +972-3-9191648

Email: adir@hospitech.co.il

Results disclosure agreements

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

Restriction type: LTE60