N/A
Completed N=751
Protocolized Post-Extubation Respiratory Support Study
Mechanical Ventilation Complication · Respiratory Failure · Intubation Complication
Source: ClinicalTrials.gov NCT03288311 ↗
Enrolled (actual)
751
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Reintubation — 57; 52 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reintubation |
57; 52 | — |
| SECONDARY All-cause In-hospital Death |
29; 41 | — |
| SECONDARY ICU-free Days |
26; 26 | — |
| SECONDARY Ventilator-free Days |
28; 28 | — |
| SECONDARY Time to Reintubation |
56; 47 | — |
| SECONDARY Number of Patients Requiring Re-intubation for Respiratory Indication |
35; 33 | — |
| SECONDARY Number of Patients Requiring Reintubation for Laryngeal Edema |
0; 2 | — |
| SECONDARY Number of Patients With Delirium |
160; 151 | — |
| SECONDARY Number of Patients With Agitation |
— | — |
| SECONDARY Lowest S/F Ratio |
237.5; 268.5; 242.5; 318.5; 242.5; 327.6 | — |
| SECONDARY Highest Respiratory Rate |
23; 24; 24; 24; 25; 25 | — |
| SECONDARY Use of High Flow Nasal Cannula (HFNC) or Non-invasive Ventilation (NIV) Beyond 24 Hours Post-extubation |
26; 14 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03288311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.