Protocolized Post-Extubation Respiratory Support Study

Acute Respiratory Failure Clinical Trial

— PROPER  

Official title:

Protocolized Post-Extubation Respiratory Support (PROPER) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288311
• Other study ID #: 170650
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: April 28, 2019

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 751
• Est. completion date: April 28, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Intubation Complication
• Mechanical Ventilation Complication
• Respiratory Insufficiency

Intervention

Other:
• 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
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	within 96 hours of extubation
Secondary	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
Secondary	ICU-free Days	number of days alive from final ICU transfer until study day 28	from extubation to discharge or 28 days post-extubation
Secondary	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
Secondary	Time to Reintubation	Time from extubation to reintubation	from extubation to discharge or 28 days post-extubation
Secondary	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
Secondary	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
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.	within 96 hours of extubation
Secondary	Number of Patients With Agitation	As defined by RAS score and reported by bedside nurse	within 96 hours of extubation
Secondary	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
Secondary	Highest Respiratory Rate	Highest respiratory rate	between 0-6 hours, 6-12 hours, and 12-24 hours after extubation
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	from 24 hours post extubation to 96 hours post-extubation