Health TrialsbyHealthPanel

Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

ConditionsObesity, MorbidExtubation Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center

About this trial

Around 20% of the obese patients with higher body mass index (BMI) who are taken off the breathing tube and breathing machine (ventilator) end up needing it back to support breathing. The re-application of breathing tube is associated with poor outcomes, including high risk of pneumonia, longer hospital stays, and death. The purpose of this study is to assess if prophylactic use of noninvasive breathing support after removing the breathing tube lowers the chance of needing the breathing tube again.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult, age ≥ 18 years old

Receiving invasive mechanical ventilation for ≥24 hours

BMI ≥40 kg/m2

Undergoing planned extubation per treating team

Disqualifiers

Pregnant

Use of extra-corporeal membrane oxygenation

Chronic tracheostomy in place

Unplanned or accidental extubation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Noninvasive ventilation alternating with high flow nasal cannula

    Device

    A total of 24 hours of prophylactic respiratory support will be provided using NIV alternating with HFNC with total NIV usage of 16 hours and HFNC usage of 8 hours.

  • High flow nasal cannula

    Device

    A total of 24 hours of prophylactic respiratory support will be provided using HFNC alone.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Intervention Group (NIV with HFNC)Experimental treatment 1 intervention
Group B: Control Group (HFNC alone)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation

Rescue respiratory support is defined as reintubation, use of rescue NIV or HFNC use

Time frame
72 hours

Secondary outcomes

1

Reintubation rate

Need for invasive mechanical ventilation within 7 days of extubation

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rush University Medical Center

Lead sponsor

Hospital Civil de Guadalajara

Collaborator

Medical College of Wisconsin

Collaborator

The University of Texas Health Science Center, Houston

Collaborator

Central DuPage Hospital

Collaborator

Source ClinicalTrials.gov
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