Protocolized Post-Extubation Respiratory Support Study

NCT03288311 | Completed Results

• 1 other identifier: 170650
• Study Type: interventional
• Target: 751
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Complication; Acute Respiratory Failure; Intubation Complication

Outcome Measures

Primary Outcomes (1)

• Reintubation

  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

  within 96 hours of extubation

Secondary Outcomes (11)

• All-cause In-hospital Death

  from extubation to discharge or 28 days post-extubation

• ICU-free Days

  from extubation to discharge or 28 days post-extubation

• Ventilator-free Days

  from extubation to discharge or 28 days post-extubation

• Time to Reintubation

  from extubation to discharge or 28 days post-extubation

• Number of Patients Requiring Re-intubation for Respiratory Indication

  within 96 hours of extubation

Study Arms (2)

Protocolized Post-extubation Respiratory Support

ACTIVE COMPARATOR

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

Other: Protocolized post-extubation respiratory support

Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

Protocolized post-extubation respiratory support OTHER

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

Usual Care OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (2)

• 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.

  PMID: 33794131 DERIVED

• 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.

  PMID: 31377713 DERIVED

Results Point of Contact

• Title: Jonathan Casey, Assistant Professor of Medicine
• Organization: Vanderbilt University Medical Center

Jonathan.d.Casey@vumc.org

6158754681

Study Officials

• Todd W Rice, MD, MSc

  Vanderbilt University Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary and Critical Care Medicine Research Fellow

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 20, 2017
• Study Start: October 1, 2017
• Primary Completion: March 31, 2019
• Study Completion: April 28, 2019
• Last Updated: December 29, 2023
• Results First Posted: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available following publication of the primary trial results
• Access Criteria: Data dictionary will be available upon requests. Requests for deidentified patient-level data will be reviewed by the trial steering committee. Sharing of deidentified data will require approval of proposed secondary analysis and a signed data use agreement.

Locations

US (1)