NCT03288311: PROPER

Protocolized Post-Extubation Respiratory Support Study

Completed NA Results posted Last updated 29 December 2023

What this trial tests

NA trial testing Protocolized post-extubation respiratory support in Mechanical Ventilation Complication in 751 participants. Completed in 28 April 2019.

Timeline

1 October 2017

Primary endpoint
31 March 2019

28 April 2019

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	751
Start date	1 October 2017
Primary completion	31 March 2019
Estimated completion	28 April 2019
Sites	1 location across United States

Drugs / interventions tested

• Protocolized post-extubation respiratory support
• Usual Care

Conditions studied

• Mechanical Ventilation Complication — all drugs for Mechanical Ventilation Complication →
• Acute Respiratory Failure — all drugs for Acute Respiratory Failure →
• Intubation Complication — all drugs for Intubation Complication →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Mechanical Ventilation Complication or Acute Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Reintubation Primary · 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

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	57
Usual Care	52

All-cause In-hospital Death Secondary · from extubation to discharge or 28 days post-extubation

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

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	29
Usual Care	41

ICU-free Days Secondary · from extubation to discharge or 28 days post-extubation

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

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	26	23 – 26
Usual Care	26	22 – 26

Ventilator-free Days Secondary · from extubation to discharge or 28 days post-extubation

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

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	28	28 – 28
Usual Care	28	28 – 28

Time to Reintubation Secondary · from extubation to discharge or 28 days post-extubation

Time from extubation to reintubation

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	56	21 – 147
Usual Care	47	18 – 163

Number of Patients Requiring Re-intubation for Respiratory Indication Secondary · within 96 hours of extubation

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

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	35
Usual Care	33

Number of Patients Requiring Reintubation for Laryngeal Edema Secondary · within 96 hours of extubation

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

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	0
Usual Care	2

Number of Patients With Delirium Secondary · 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.

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	160
Usual Care	151

Lowest S/F Ratio Secondary · between 0-6 hours, 6-12 hours, and 12-24 hours after extubation

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

0-6 hours

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	237.5	205.0 – 254.3
Usual Care	268.5	224.4 – 344.4

6-12 hours

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	242.5	222.5 – 303.3
Usual Care	318.5	240.0 – 438.1

12-24 hours

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	242.5	214.6 – 340.7
Usual Care	327.6	240.0 – 438.1

Highest Respiratory Rate Secondary · between 0-6 hours, 6-12 hours, and 12-24 hours after extubation

Highest respiratory rate

0-6 hours

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	23	20 – 28
Usual Care	24	21 – 28

6-12 hours

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	24	19 – 28
Usual Care	24	20 – 29

12-24 hours

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	25	21 – 30
Usual Care	25	21 – 29

Use of High Flow Nasal Cannula (HFNC) or Non-invasive Ventilation (NIV) Beyond 24 Hours Post-extubation Secondary · 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

Group	Value	95% CI
Protocolized Post-extubation Respiratory Support	26
Usual Care	14

Sponsor's own description

Invasive mechanical ventilation is common in the medical intensive care unit, and the period of time following extubation remains high risk as 11 to 15% of patients require reintubation after their first extubation. Reintubation is associated with increased rates of nosocomial infection and is an independent predictor of mortality. Non-invasive ventilation and high flow nasal cannula are the only therapies that have been shown to reduce the rate of reintubation. Recent clinical trials suggest that all patients might benefit from some form of post-extubation respiratory support, but use of these therapies in usual care remains low. PROPER is a cluster-randomized, multiple-crossover trial comparing a respiratory therapist driven protocol to provide post-extubation respiratory support to all patients, compared to usual care. The trial will enroll patients undergoing extubation in the Medical ICU at Vanderbilt from October 2017 until March 2019. The primary outcome will be reintubation within 96 hours.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Protocolized Postextubation Respiratory Support to Prevent Reintubation: A Randomized Clinical Trial.
   Casey JD, Vaughan EM, Lloyd BD, Billas PA, et al · · 2021 · cited 22× · PMID 33794131 · DOI 10.1164/rccm.202009-3561oc
2. Protocolized Post-Extubation Respiratory Support to prevent reintubation: protocol and statistical analysis plan for a clinical trial.
   Casey JD, Vaughan ER, Lloyd BD, Bilas PA, et al · · 2019 · cited 4× · PMID 31377713 · DOI 10.1136/bmjopen-2019-030476