Status:
WITHDRAWN
Early Extubation for Patients With Acute Hypoxemic Respiratory Failure
Lead Sponsor:
University of Chicago
Conditions:
Mechanical Ventilation
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the study is to evaluate the efficacy of helmet NIV in reducing the duration of invasive mechanical ventilation in order to minimize ventilator needs during the COVID-19 pandemic.
Detailed Description
Single center randomized clinical trial investigating the efficacy of helmet NIV used for early liberation from mechanical ventilation in patients with acute hypoxemic respiratory failure. Interventi...
Eligibility Criteria
Inclusion
- Age ≥18 years old on mechanical ventilation for at least 48 hours Positive End Expiratory Pressure (PEEP) level between 8 to 13cm H20 The ratio between the partial pressure of oxygen and fraction of inspired oxygen (PaO2/FiO2) between 150 and 300 mmHg with FiO2≤0.6 pH≥7.25 Respiratory rate (RR)≤30/min Adequate gag and cough reflex Ability to spontaneously breathe
Exclusion
- Hemodynamic instability (Systolic blood pressure \<90 or requiring \>2 vasoactive agents) Tracheostomy Upper airway obstruction Pregnancy Elevated intracranial pressure Upper airway obstruction Glasgow coma scale ≤ 8 Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach
Key Trial Info
Start Date :
August 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04349332
Start Date
August 13 2020
End Date
January 9 2024
Last Update
May 2 2024
Active Locations (1)
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1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637