Clinical trial NCT03288311: Protocolized Post-Extubation Respiratory Support Study
Official title: Protocolized Post-Extubation Respiratory Support (PROPER) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Acute Respiratory Failure
Intubation Complication
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 751
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: PROPER is a prospective, pragmatic, cluster-randomized, multiple-crossover trial comparing a respiratory therapist driven protocol for post-extubation respiratory support to usual care. The primary outcome will be reintubation by 96 hours. All adults (age 18 or older) who receive at least 12 hours of mechanical ventilation and are extubated in the Vanderbilt Medical ICU will be enrolled in the trial. The ICU will be divided into 2 clusters, based on the geographic areas covered by the two respiratory therapist dedicated to that ICU. The study will occur in three month blocks. One cluster will be randomized to receive protocolized post-extubation respiratory support (as prescribed by a protocol and delivered by a respiratory therapist), while the other cluster receives usual care, which can include post-extubation respiratory support when requested by the clinical team. At the end of three months, the clusters will cross-over, such that each cluster will spend half of the study receiving protocolized post-extubation respiratory and half of the study receiving usual care. It is anticipated that approximately 630 patients will be enrolled from the medical ICU during the 18 month study period.

Eligibility criteria: Inclusion Criteria:

1. Patient is located in a participating unit
2. Patient undergoing extubation from mechanical ventilation
3. Patient has been receiving mechanical ventilation for at least 12 hours
4. Age ≥ 18 years old

Exclusion Criteria:

1. Patient is receiving ventilation via a tracheostomy
2. Patient is being extubated to comfort measures or has "Do Not Reintubate" order in place at the time of extubation
3. Patient has required reintubation after a prior attempt at extubation during this hospitalization
4. Unplanned or self-extubation, where immediate reintubation is deemed necessary by the clinical team

Primary outcomes:
measure: Reintubation
timeFrame: within 96 hours of extubation
Secondary outcomes:
measure: All-cause In-hospital Death
timeFrame: from extubation to discharge or 28 days post-extubation
measure: ICU-free Days
timeFrame: from extubation to discharge or 28 days post-extubation
measure: Ventilator-free Days
timeFrame: from extubation to discharge or 28 days post-extubation
measure: Time to Reintubation
timeFrame: from extubation to discharge or 28 days post-extubation
measure: Number of Patients Requiring Re-intubation for Respiratory Indication
timeFrame: within 96 hours of extubation
measure: Number of Patients Requiring Reintubation for Laryngeal Edema
timeFrame: within 96 hours of extubation
measure: Number of Patients With Delirium
timeFrame: within 96 hours of extubation
measure: Number of Patients With Agitation
timeFrame: within 96 hours of extubation
measure: Lowest S/F Ratio
timeFrame: between 0-6 hours, 6-12 hours, and 12-24 hours after extubation
measure: Highest Respiratory Rate
timeFrame: between 0-6 hours, 6-12 hours, and 12-24 hours after extubation
measure: Use of High Flow Nasal Cannula (HFNC) or Non-invasive Ventilation (NIV) Beyond 24 Hours Post-extubation
timeFrame: from 24 hours post extubation to 96 hours post-extubation
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Todd W Rice, MD, MSc
role: STUDY_CHAIR
References:
citation: Casey JD, Vaughan EM, Lloyd BD, Billas PA, Jackson KE, Hall EJ, Toporek AH, Buell KG, Brown RM, Richardson RK, Rooks JC, Buie RB, Wang L, Lindsell CJ, Ely EW, Self WH, Bernard GR, Rice TW, Semler MW. Protocolized Postextubation Respiratory Support to Prevent Reintubation: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2021 Aug 1;204(3):294-302. doi: 10.1164/rccm.202009-3561OC.
citation: Casey JD, Vaughan ER, Lloyd BD, Bilas PA, Hall EJ, Toporek AH, Buell KG, Brown RM, Richardson RK, Rooks JC, Wang L, Lindsell CJ, Ely EW, Self WH, Bernard GR, Rice TW, Semler MW; Pragmatic Critical Care Research Group. Protocolized Post-Extubation Respiratory Support to prevent reintubation: protocol and statistical analysis plan for a clinical trial. BMJ Open. 2019 Aug 2;9(8):e030476. doi: 10.1136/bmjopen-2019-030476.