Protocolized Post-Extubation Respiratory Support Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/5/2019 |
| Start Date: | October 1, 2017 |
| End Date: | April 30, 2019 |
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.
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.
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.
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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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