Protocolized Post-Extubation Respiratory Support Study (PROPER)

Vanderbilt University Medical Center

Status: Completed

Conditions: Mechanical Ventilation Complication; Acute Respiratory Failure; Intubation Complication

Treatments: Other: Protocolized post-extubation respiratory support; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03288311

170650

Details and patient eligibility

About

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.

Full 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.

Enrollment: 751 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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751 participants in 2 patient groups

Protocolized Post-extubation Respiratory Support

Active Comparator group

Description:

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

Treatment:

Other: Protocolized post-extubation respiratory support

Usual Care

Active Comparator group

Description:

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.

Treatment:

Other: Usual Care