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Completed

NCT Number: NCT03288311

Protocolized Post-Extubation Respiratory Support 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.

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Key information

Conditions

Mechanical Ventilation Complication Acute Respiratory Failure Intubation Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protocolized post-extubation respiratory support

Other

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

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. All-cause In-hospital Death

    Time frame: from extubation to discharge or 28 days post-extubation

    All cause mortality, censored at the first of hospital discharge or 28 days after extubation

  2. ICU-free Days

    Time frame: from extubation to discharge or 28 days post-extubation

    number of days alive from final ICU transfer until study day 28

  3. Ventilator-free Days

    Time frame: from extubation to discharge or 28 days post-extubation

    number of days alive from final invasive mechanical ventilation until study day 28

  4. Time to Reintubation

    Time frame: from extubation to discharge or 28 days post-extubation

    Time from extubation to reintubation

  5. Number of Patients Requiring Re-intubation for Respiratory Indication

    Time frame: within 96 hours of extubation

    Number of patients in each group with respiratory indication for reintubation.

  6. Number of Patients Requiring Reintubation for Laryngeal Edema

    Time frame: within 96 hours of extubation

    Percentage of patients in each group with laryngeal edema as the indication for reintubation

  7. Number of Patients With Delirium

    Time frame: within 96 hours of extubation

    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.

  8. Number of Patients With Agitation

    Time frame: within 96 hours of extubation

    As defined by RAS score and reported by bedside nurse

  9. Lowest S/F Ratio

    Time frame: between 0-6 hours, 6-12 hours, and 12-24 hours after extubation

    Lowest ratio of O2 saturation to concentration inhaled oxygen (FIO2)

  10. Highest Respiratory Rate

    Time frame: between 0-6 hours, 6-12 hours, and 12-24 hours after extubation

    Highest respiratory rate

  11. 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

    Use of non-invasive ventilation or high flow nasal cannula beyond 24 hours post-extubation

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Protocolized Post-Extubation Respiratory Support (PROPER) Study

Acronym: PROPER

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 20, 2017
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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