Trial Outcomes & Findings for Postextubation Management in Patients at Risk for Extubation Failure (NCT NCT04258020)

NCT ID: NCT04258020

Last Updated: 2022-01-13

Results Overview

The number of patients who require re-intubation

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 72 hours following extubation
• Results posted on: 2022-01-13

Participant Flow

Two participants in the experimental group withdrew from the study prior to intervention. One participant in the experimental group withdrew consent at time of regained capacity. Because the study was terminated (halted prematurely) no data were collected for the historical control group.

Participant milestones

Measure	Experimental: Alternating BiPAP and HFNC Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration	Historical Control: Standard of Care A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
Overall Study STARTED	4	0
Overall Study COMPLETED	3	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Experimental: Alternating BiPAP and HFNC Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration	Historical Control: Standard of Care A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Postextubation Management in Patients at Risk for Extubation Failure

Baseline characteristics by cohort

Measure	Experimental: Alternating BiPAP and HFNC n=3 Participants Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration	Historical Control: Standard of Care A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	—	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours following extubation

Population: Because the study was terminated (halted prematurely), no historical control data were collected

The number of patients who require re-intubation

Outcome measures

Measure	Experimental: Alternating BiPAP and HFNC n=3 Participants Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration	Historical Control: Standard of Care A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
Re-intubation Within 72 Hours	0 participants	—

SECONDARY outcome

Timeframe: 1 week following extubation

Population: Because the study was terminated (halted prematurely), no historical control data were collected

The number of patients who require re-intubation

Outcome measures

Measure	Experimental: Alternating BiPAP and HFNC n=3 Participants Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration	Historical Control: Standard of Care A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
Re-intubation Within 1 Week	0 participants	—

SECONDARY outcome

Timeframe: Through hospital discharge, an average of 10.9 ± 1.91 days

Population: Because the study was terminated (halted prematurely), no historical control data were collected

Hospital length of stay

Outcome measures

Measure	Experimental: Alternating BiPAP and HFNC n=3 Participants Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration	Historical Control: Standard of Care A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
Length of Stay	10.9 Days Standard Deviation 1.91	—

SECONDARY outcome

Timeframe: Through hospital discharge, an average of 10.9 ± 1.91 days

Population: Because the study was terminated (halted prematurely), no historical control data were collected

The total duration of time patients spend on a ventilator

Outcome measures

Measure	Experimental: Alternating BiPAP and HFNC n=3 Participants Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration	Historical Control: Standard of Care A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
Ventilator Time	3.5 Days Standard Deviation 1.33	—

SECONDARY outcome

Timeframe: Through hospital discharge, an average of 10.9 ± 1.91 days

Population: Because the study was terminated (halted prematurely), no historical control data were collected

The proportion of patients who expire during the hospital stay

Outcome measures

Measure	Experimental: Alternating BiPAP and HFNC n=3 Participants Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration	Historical Control: Standard of Care A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
Mortality	0 Participants	—

SECONDARY outcome

Timeframe: Through 1 week following extubation

Population: Because the study was terminated (halted prematurely), no historical control data were collected

The proportion of patients experiencing an adverse event

Outcome measures

Measure	Experimental: Alternating BiPAP and HFNC n=3 Participants Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration	Historical Control: Standard of Care A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
Adverse Event Rate	1 Participants	—

SECONDARY outcome

Timeframe: 30 days following discharge

Population: Because the study was terminated (halted prematurely), no historical control data were collected

The proportion of patients who require re-admission within 30 days of discharge

Outcome measures

Measure	Experimental: Alternating BiPAP and HFNC n=3 Participants Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration	Historical Control: Standard of Care A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
30-day Readmission	0 Participants	—

Adverse Events

Experimental: Alternating BiPAP and HFNC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Historical Control: Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Experimental: Alternating BiPAP and HFNC n=3 participants at risk Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration	Historical Control: Standard of Care A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Through hospital discharge, and average of 10.9 days. All patients were assessed for adverse events through hospital discharge	— 0/0 • Through hospital discharge, and average of 10.9 days. All patients were assessed for adverse events through hospital discharge

Additional Information

Dr. Kiran Devulapally

OhioHealth

Phone: 614-566-9143

Email: kiran.devulapally@ohiohealth.com

Results disclosure agreements

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