Trial Outcomes & Findings for Protocolized Post-Extubation Respiratory Support Study (NCT NCT03288311)

Results Overview

Any placement of an endotracheal tube for any indication within 96 hours of extubation, censored at the first of hospital discharge or 96 hours after extubation

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

751 participants

Primary outcome timeframe

within 96 hours of extubation

Results posted on

2023-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	Protocolized Post-extubation Respiratory Support Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning Protocolized post-extubation respiratory support: Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning	Usual Care Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team. Usual Care: Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.
Overall Study STARTED	359	392
Overall Study COMPLETED	359	392
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Protocolized Post-Extubation Respiratory Support Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Protocolized Post-extubation Respiratory Support n=359 Participants Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning Protocolized post-extubation respiratory support: Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning	Usual Care n=392 Participants Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team. Usual Care: Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.	Total n=751 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	57 years n=7 Participants	57 years n=5 Participants
Sex: Female, Male Female	155 Participants n=5 Participants	187 Participants n=7 Participants	342 Participants n=5 Participants
Sex: Female, Male Male	204 Participants n=5 Participants	205 Participants n=7 Participants	409 Participants n=5 Participants
Race/Ethnicity, Customized White	287 Participants n=5 Participants	317 Participants n=7 Participants	604 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	58 Participants n=5 Participants	59 Participants n=7 Participants	117 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 96 hours of extubation

Any placement of an endotracheal tube for any indication within 96 hours of extubation, censored at the first of hospital discharge or 96 hours after extubation

Outcome measures

Outcome measures
Measure	Protocolized Post-extubation Respiratory Support n=359 Participants Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning Protocolized post-extubation respiratory support: Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning	Usual Care n=392 Participants Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team. Usual Care: Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.
Reintubation	57 Participants	52 Participants

SECONDARY outcome

Timeframe: from extubation to discharge or 28 days post-extubation

All cause mortality, censored at the first of hospital discharge or 28 days after extubation

Outcome measures

Outcome measures
Measure	Protocolized Post-extubation Respiratory Support n=359 Participants Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning Protocolized post-extubation respiratory support: Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning	Usual Care n=392 Participants Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team. Usual Care: Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.
All-cause In-hospital Death	29 Participants	41 Participants

SECONDARY outcome

Timeframe: from extubation to discharge or 28 days post-extubation

number of days alive from final ICU transfer until study day 28

Outcome measures

Outcome measures
Measure	Protocolized Post-extubation Respiratory Support n=359 Participants Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning Protocolized post-extubation respiratory support: Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning	Usual Care n=392 Participants Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team. Usual Care: Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.
ICU-free Days	26 days Interval 23.0 to 26.0	26 days Interval 22.0 to 26.0

SECONDARY outcome

Timeframe: from extubation to discharge or 28 days post-extubation

number of days alive from final invasive mechanical ventilation until study day 28

Outcome measures

Outcome measures
Measure	Protocolized Post-extubation Respiratory Support n=359 Participants Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning Protocolized post-extubation respiratory support: Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning	Usual Care n=392 Participants Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team. Usual Care: Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.
Ventilator-free Days	28 days Interval 28.0 to 28.0	28 days Interval 28.0 to 28.0

SECONDARY outcome

Timeframe: from extubation to discharge or 28 days post-extubation

Time from extubation to reintubation

Outcome measures

Outcome measures
Measure	Protocolized Post-extubation Respiratory Support n=359 Participants Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning Protocolized post-extubation respiratory support: Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning	Usual Care n=392 Participants Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team. Usual Care: Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.
Time to Reintubation	56 hours Interval 21.0 to 147.0	47 hours Interval 18.0 to 163.0

SECONDARY outcome

Timeframe: within 96 hours of extubation

Population: Full trial population

Number of patients in each group with respiratory indication for reintubation.

Outcome measures

Outcome measures
Measure	Protocolized Post-extubation Respiratory Support n=359 Participants Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning Protocolized post-extubation respiratory support: Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning	Usual Care n=392 Participants Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team. Usual Care: Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.
Number of Patients Requiring Re-intubation for Respiratory Indication	35 Participants	33 Participants

SECONDARY outcome

Timeframe: within 96 hours of extubation

Percentage of patients in each group with laryngeal edema as the indication for reintubation

Outcome measures

Outcome measures
Measure	Protocolized Post-extubation Respiratory Support n=359 Participants Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning Protocolized post-extubation respiratory support: Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning	Usual Care n=392 Participants Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team. Usual Care: Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.
Number of Patients Requiring Reintubation for Laryngeal Edema	0 Participants	2 Participants

SECONDARY outcome

Timeframe: within 96 hours of extubation

As defined by Confusion Assessment Method for the ICU (CAM-ICU) score and reported by bedside nurse. A report of "Yes" indicates the presence of delirium, which is reflected in the reported cases.

Outcome measures

Outcome measures
Measure	Protocolized Post-extubation Respiratory Support n=359 Participants Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning Protocolized post-extubation respiratory support: Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning	Usual Care n=392 Participants Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team. Usual Care: Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.
Number of Patients With Delirium	160 Participants	151 Participants

SECONDARY outcome

Timeframe: within 96 hours of extubation

Population: Data was unavailable for collection

As defined by RAS score and reported by bedside nurse

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: between 0-6 hours, 6-12 hours, and 12-24 hours after extubation

Lowest ratio of O2 saturation to concentration inhaled oxygen (FIO2)

Outcome measures

Outcome measures
Measure	Protocolized Post-extubation Respiratory Support n=359 Participants Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning Protocolized post-extubation respiratory support: Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning	Usual Care n=392 Participants Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team. Usual Care: Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.
Lowest S/F Ratio 0-6 hours	237.5 ratio of O2 saturation to concentration Interval 205.0 to 254.3	268.5 ratio of O2 saturation to concentration Interval 224.4 to 344.4
Lowest S/F Ratio 6-12 hours	242.5 ratio of O2 saturation to concentration Interval 222.5 to 303.3	318.5 ratio of O2 saturation to concentration Interval 240.0 to 438.1
Lowest S/F Ratio 12-24 hours	242.5 ratio of O2 saturation to concentration Interval 214.6 to 340.7	327.6 ratio of O2 saturation to concentration Interval 240.0 to 438.1

SECONDARY outcome

Timeframe: between 0-6 hours, 6-12 hours, and 12-24 hours after extubation

Highest respiratory rate

Outcome measures

Outcome measures
Measure	Protocolized Post-extubation Respiratory Support n=359 Participants Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning Protocolized post-extubation respiratory support: Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning	Usual Care n=392 Participants Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team. Usual Care: Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.
Highest Respiratory Rate 0-6 hours	23 breaths per minute Interval 20.0 to 28.0	24 breaths per minute Interval 21.0 to 28.0
Highest Respiratory Rate 6-12 hours	24 breaths per minute Interval 19.0 to 28.0	24 breaths per minute Interval 20.0 to 29.0
Highest Respiratory Rate 12-24 hours	25 breaths per minute Interval 21.0 to 30.0	25 breaths per minute Interval 21.0 to 29.0

SECONDARY outcome

Timeframe: from 24 hours post extubation to 96 hours post-extubation

Use of non-invasive ventilation or high flow nasal cannula beyond 24 hours post-extubation

Outcome measures

Outcome measures
Measure	Protocolized Post-extubation Respiratory Support n=359 Participants Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning Protocolized post-extubation respiratory support: Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning	Usual Care n=392 Participants Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team. Usual Care: Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.
Use of High Flow Nasal Cannula (HFNC) or Non-invasive Ventilation (NIV) Beyond 24 Hours Post-extubation	26 Participants	14 Participants

Adverse Events

Protocolized Post-extubation Respiratory Support

Serious events: 0 serious events

Other events: 0 other events

Deaths: 29 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 41 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Casey, Assistant Professor of Medicine

Vanderbilt University Medical Center

Phone: 6158754681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place