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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause In-hospital Death | All cause mortality, censored at the first of hospital discharge or 28 days after extubation | from extubation to discharge or 28 days post-extubation |
| ICU-free Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd W Rice, MD, MSc | Vanderbilt University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33794131 | Derived | 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. | |
| 31377713 |
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Data will be available following publication of the primary trial results
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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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | within 96 hours of extubation |
|
Adverse events were collected from enrollment to 28 days after enrollment
Because this trial compared strategies commonly used in routine clinical care, the only events that were recorded or reported as adverse events were those that were related to the study and serious or unexpected. Patients who require mechanical ventilation in the critical care setting are at risk for hypoxemia, hypotension, cardiac arrest, and death. These events were recorded as study outcomes and only recorded as AEs if related to the study intervention, which was expected to be rare.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Casey, Assistant Professor of Medicine | Vanderbilt University Medical Center | 6158754681 | Jonathan.d.Casey@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2019 | Feb 1, 2022 | Prot_SAP_000.pdf |
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| 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. |
|
number of days alive from final ICU transfer until study day 28
| from extubation to discharge or 28 days post-extubation |
| Ventilator-free Days | number of days alive from final invasive mechanical ventilation until study day 28 | from extubation to discharge or 28 days post-extubation |
| Time to Reintubation | Time from extubation to reintubation | from extubation to discharge or 28 days post-extubation |
| Number of Patients Requiring Re-intubation for Respiratory Indication | Number of patients in each group with respiratory indication for reintubation. | within 96 hours of extubation |
| Number of Patients Requiring Reintubation for Laryngeal Edema | Percentage of patients in each group with laryngeal edema as the indication for reintubation | within 96 hours of extubation |
| Number of Patients With Delirium | 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. | within 96 hours of extubation |
| Number of Patients With Agitation | As defined by RAS score and reported by bedside nurse | within 96 hours of extubation |
| Lowest S/F Ratio | Lowest ratio of O2 saturation to concentration inhaled oxygen (FIO2) | between 0-6 hours, 6-12 hours, and 12-24 hours after extubation |
| Highest Respiratory Rate | Highest respiratory rate | between 0-6 hours, 6-12 hours, and 12-24 hours after extubation |
| Use of High Flow Nasal Cannula (HFNC) or Non-invasive Ventilation (NIV) Beyond 24 Hours Post-extubation | Use of non-invasive ventilation or high flow nasal cannula beyond 24 hours post-extubation | from 24 hours post extubation to 96 hours post-extubation |
| 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | 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. |
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| Secondary | All-cause In-hospital Death | All cause mortality, censored at the first of hospital discharge or 28 days after extubation | Posted | Count of Participants | Participants | from extubation to discharge or 28 days post-extubation |
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| Secondary | ICU-free Days | number of days alive from final ICU transfer until study day 28 | Posted | Median | Inter-Quartile Range | days | from extubation to discharge or 28 days post-extubation |
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| Secondary | Ventilator-free Days | number of days alive from final invasive mechanical ventilation until study day 28 | Posted | Median | Inter-Quartile Range | days | from extubation to discharge or 28 days post-extubation |
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| Secondary | Time to Reintubation | Time from extubation to reintubation | Posted | Median | Inter-Quartile Range | hours | from extubation to discharge or 28 days post-extubation |
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| Secondary | Number of Patients Requiring Re-intubation for Respiratory Indication | Number of patients in each group with respiratory indication for reintubation. | Full trial population | Posted | Count of Participants | Participants | within 96 hours of extubation |
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| Secondary | Number of Patients Requiring Reintubation for Laryngeal Edema | Percentage of patients in each group with laryngeal edema as the indication for reintubation | Posted | Count of Participants | Participants | within 96 hours of extubation |
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| Secondary | Number of Patients With Delirium | 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. | Posted | Count of Participants | Participants | within 96 hours of extubation |
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| Secondary | Number of Patients With Agitation | As defined by RAS score and reported by bedside nurse | Data was unavailable for collection | Posted | within 96 hours of extubation |
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| Secondary | Lowest S/F Ratio | Lowest ratio of O2 saturation to concentration inhaled oxygen (FIO2) | Posted | Median | Inter-Quartile Range | ratio of O2 saturation to concentration | between 0-6 hours, 6-12 hours, and 12-24 hours after extubation |
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| Secondary | Highest Respiratory Rate | Highest respiratory rate | Posted | Median | Inter-Quartile Range | breaths per minute | between 0-6 hours, 6-12 hours, and 12-24 hours after extubation |
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| Secondary | Use of High Flow Nasal Cannula (HFNC) or Non-invasive Ventilation (NIV) Beyond 24 Hours Post-extubation | Use of non-invasive ventilation or high flow nasal cannula beyond 24 hours post-extubation | Posted | Count of Participants | Participants | from 24 hours post extubation to 96 hours post-extubation |
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| 29 |
| 359 |
| 0 |
| 359 |
| 0 |
| 359 |
| EG001 | 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. | 41 | 392 | 0 | 392 | 0 | 392 |
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| 12-24 hours |
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| 12-24 hours |
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