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Protocolized Post-Extubation Respiratory Support Study (PROPER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03288311
Recruitment Status : Completed
First Posted : September 20, 2017
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Jonathan Casey, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Complication Acute Respiratory Failure Intubation Complication Other: Protocolized post-extubation respiratory support Other: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 751 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Protocolized Post-Extubation Respiratory Support (PROPER) Study
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : April 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Other: 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

Active Comparator: 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.
Other: 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.




Primary Outcome Measures :
  1. Reintubation [ Time Frame: 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


Secondary Outcome Measures :
  1. All-cause in-hospital death [ Time Frame: from extubation to discharge or 28 days post-extubation ]
    All cause mortality, censored at the first of hospital discharge or 28 days after extubation

  2. ICU-free days [ Time Frame: from extubation to discharge or 28 days post-extubation ]
    number of days alive from final ICU transfer until study day 28

  3. Ventilator-free days [ Time Frame: from extubation to discharge or 28 days post-extubation ]
    number of days alive from final invasive mechanical ventilation until study day 28

  4. Time to reintubation [ Time Frame: from extubation to discharge or 28 days post-extubation ]
    Time from extubation to reintubation

  5. Indication for re-intubation [ Time Frame: within 96 hours of extubation ]
    Proportion of patients in each group with respiratory vs non-respiratory indications for reintubation

  6. Laryngeal edema requiring reintubation [ Time Frame: within 96 hours of extubation ]
    Proportion of patients in each group with laryngeal edema as the indication for reintubation

  7. Delirium [ Time Frame: within 96 hours of extubation ]
    As defined by CAM-ICU score and reported by bedside nurse

  8. Agitation [ Time Frame: within 96 hours of extubation ]
    As defined by RAS score and reported by bedside nurse

  9. Lowest S/F ratio [ Time Frame: between 0-6 hours, 6-12 hours, and 12-24 hours after extubation ]
    Lowest ratio of O2 saturation to concentration inhaled oxygen (FIO2)

  10. Highest respiratory rate [ Time Frame: between 0-6 hours, 6-12 hours, and 12-24 hours after extubation ]
    Highest respiratory rate

  11. Use of HFNC or NIV beyond 24 hours post-extubation [ Time Frame: from extubation to 96 hours post-extubation ]
    Use of non-invasive ventilation or high flow nasal cannula beyond 24 hours post-extubation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288311


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Study Chair: Todd W Rice, MD, MSc Vanderbilt University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonathan Casey, Pulmonary and Critical Care Medicine Research Fellow, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03288311    
Other Study ID Numbers: 170650
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases