Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT05918575
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 10, 2023
Status verified
Oct 2025
Primary completion
Jul 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group (NIV with HFNC)
    Patients randomized to the intervention group will receive NIV alternating with HFNC for 24 hours after extubation
  • Active Comparator: Control Group (HFNC alone)
    Patients randomized to the intervention group will receive HFNC only for 24 hours after extubation

Primary Outcome Measure

Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation [ Time Frame: 72 hours ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Ramandeep Kaur, PhD
[email protected]
Babak Mokhlesi, MD
[email protected]
Ramandeep Kaur, PhD (PRINCIPAL_INVESTIGATOR)
Babak Mokhlesi, MD (PRINCIPAL_INVESTIGATOR)
Central DuPage HospitalWinfieldIllinois60190
Ankeet Patel
[email protected]
Ankeet Patel (PRINCIPAL_INVESTIGATOR)
McGovern Medical School, The University of Texas Health Science CenterHoustonTexas77030
Rosa M. Estrada-Y-Martin, MD
[email protected]
Rosa M. Estrada-Y-Martin, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Rahul Nanchal, MD
[email protected]
Rahul Nanchal, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Rush University Medical Center· Chicago, ILCentral DuPage Hospital· Winfield, ILMcGovern Medical School, The University of Texas Health Science Center· Houston, TXMedical College of Wisconsin· Milwaukee, WI

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