Trial Outcomes & Findings for Entrainment-Based Mechanical Ventilation (NCT NCT03512067)

NCT ID: NCT03512067

Last Updated: 2019-09-11

Results Overview

Total number of asynchronous breaths/hour during entrainment-based ventilation compared to baseline ventilation.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: 8 Hours
• Results posted on: 2019-09-11

Participant Flow

Participant milestones

Measure	Patients Given EMV Ventilation Baseline mechanical ventilation data with conventional pressure-limited assist/control ventilation mode will then be collected for a 4-hour period. The patients will then be transitioned to pressure-limited entrainment-based ventilation (EMV) for a 4-hour period. Baseline ventilation monitoring will be carried out either immediately preceding or immediately following EMV in the same patient. The sequence of the control/baseline phase and the experimental phase of the study will be randomized.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Entrainment-Based Mechanical Ventilation

Baseline characteristics by cohort

Measure	Patients Given EMV Ventilation n=1 Participants Baseline mechanical ventilation data with conventional pressure-limited assist/control ventilation mode will then be collected for a 4-hour period. The patients will then be transitioned to pressure-limited entrainment-based ventilation (EMV) for a 4-hour period. Baseline ventilation monitoring will be carried out either immediately preceding or immediately following EMV in the same patient. The sequence of the control/baseline phase and the experimental phase of the study will be randomized.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants
Respiratory Rate	12 breaths/minute n=5 Participants

PRIMARY outcome

Timeframe: 8 Hours

Total number of asynchronous breaths/hour during entrainment-based ventilation compared to baseline ventilation.

Outcome measures

Measure	Patients Given EMV Ventilation n=1 Participants Baseline mechanical ventilation data with conventional pressure-limited assist/control ventilation mode will then be collected for a 4-hour period. The patients will then be transitioned to pressure-limited entrainment-based ventilation (EMV) for a 4-hour period. Baseline ventilation monitoring will be carried out either immediately preceding or immediately following EMV in the same patient. The sequence of the control/baseline phase and the experimental phase of the study will be randomized.
Feasibility Evaluation 4 Hour Session 1: Total # of Asynchronous Breaths	1372 breaths
Feasibility Evaluation 4 Hour Session 2: Total # of Asynchronous Breaths	1402 breaths

SECONDARY outcome

Timeframe: 8 Hours

With 20 patients we will have an 88% chance of seeing any complication (such as those defined by the safety criteria or any associated adverse event or serious adverse event) that occurs with a frequency of 10% or more.

Outcome measures

Measure

Patients Given EMV Ventilation n=1 Participants Baseline mechanical ventilation data with conventional pressure-limited assist/control ventilation mode will then be collected for a 4-hour period. The patients will then be transitioned to pressure-limited entrainment-based ventilation (EMV) for a 4-hour period. Baseline ventilation monitoring will be carried out either immediately preceding or immediately following EMV in the same patient. The sequence of the control/baseline phase and the experimental phase of the study will be randomized.

Assess for Frequency of Complications Related to the Use of EMV

0 Participants

Adverse Events

Patients Given EMV Ventilation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gyorgy Frendl

Brigham and Women's Hospital

Phone: 617-732-5910

Email: gfrendl@bwh.harvard.edu

Results disclosure agreements

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