Mechanical Ventilation ComplicationPROPERNCT03288311
Protocolized Post-Extubation Respiratory Support Study
A study testing Protocolized post-extubation respiratory support in people with Mechanical Ventilation Complication and Acute Respiratory Failure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Acute Respiratory Failure, Intubation Complication
- What is being tested?
- Protocolized post-extubation respiratory support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 751 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 28 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Protocolized Post-Extubation Respiratory Support (PROPER) Study
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.
Read the 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.
- Being tested
- Protocolized post-extubation respiratory support, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolized post-extubation respiratory supportOther
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
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 96 hours of extubation
Secondary outcomes (11)
All-cause In-hospital Death
All cause mortality, censored at the first of hospital discharge or 28 days after extubation
Measured: from extubation to discharge or 28 days post-extubation
ICU-free Days
number of days alive from final ICU transfer until study day 28
Measured: 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
Measured: from extubation to discharge or 28 days post-extubation
Time to Reintubation
Time from extubation to reintubation
Measured: 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.
Measured: 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
Measured: 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.
Measured: within 96 hours of extubation
Number of Patients With Agitation
As defined by RAS score and reported by bedside nurse
Measured: within 96 hours of extubation
Lowest S/F Ratio
Lowest ratio of O2 saturation to concentration inhaled oxygen (FIO2)
Measured: between 0-6 hours, 6-12 hours, and 12-24 hours after extubation
Highest Respiratory Rate
Highest respiratory rate
Measured: 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
Measured: from 24 hours post extubation to 96 hours post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start1 Oct 2017
- Primary completion31 Mar 2019
- Study completion28 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 751 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Casey, Vanderbilt University Medical Center
- Investigators
- Todd W Rice, MD, MSc, Study chair, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288311
- Sponsor's protocol ID
- 170650
- Acronym
- PROPER
- Status last verified
- Dec 2023
- First submitted
- 15 Sep 2017
- Last updated
- 29 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 33794131Casey 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.
PubMed 31377713
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocolized Post-Extubation Respiratory Support (PROPER) Study
- ClinicalTrials.gov ID
- NCT03288311
- Acronym / sponsor ID
- PROPER / 170650
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 751 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 28 Apr 2019 (actual)
- First posted
- 20 Sep 2017 (actual)
- Results
- Posted 29 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protocolized Post-extubation Respiratory Support | Active comparator | Other: Protocolized post-extubation respiratory supportQualifying 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 |
| Usual Care | Active comparator | Other: Usual CareQualifying 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocolized post-extubation respiratory supportQualifying 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 CareQualifying 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 |
Primary outcome
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
11 secondary outcomes
All-cause In-hospital Death
Time frame: from extubation to discharge or 28 days post-extubation
ICU-free Days
Time frame: from extubation to discharge or 28 days post-extubation
Ventilator-free Days
Time frame: from extubation to discharge or 28 days post-extubation
Time to Reintubation
Time frame: from extubation to discharge or 28 days post-extubation
Number of Patients Requiring Re-intubation for Respiratory Indication
Time frame: within 96 hours of extubation
Number of Patients Requiring Reintubation for Laryngeal Edema
Time frame: within 96 hours of extubation
Number of Patients With Delirium
Time frame: within 96 hours of extubation
Number of Patients With Agitation
Time frame: within 96 hours of extubation
Lowest S/F Ratio
Time frame: between 0-6 hours, 6-12 hours, and 12-24 hours after extubation
Highest Respiratory Rate
Time frame: 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
Time frame: from 24 hours post extubation to 96 hours post-extubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33794131Casey 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.
- Derived from this study: PubMed 31377713Casey 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd W Rice, MD, MSc study chair
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocolized post-extubation respiratory support in people with Mechanical Ventilation Complication and Acute Respiratory Failure, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reintubation (time frame: within 96 hours of extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03288311, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.