Comparative Study Between Noninvasive Ventilation and High Flow Nasal Cannula in Patients With High Risk of Extubation Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Benha University
- Enrollment
- 102
- Locations
- 1
Study Overview
Brief Summary
Extubation failure is associated with increased morbidity and mortality in critically ill patients. High-risk patients may benefit from preventive respiratory support after extubation. This randomized controlled trial compared noninvasive ventilation (NIV) with high-flow nasal cannula (HFNC) in adult intensive care unit (ICU) patients at high risk of extubation failure. The study evaluated reintubation rates, time to reintubation, physiological parameters, complications, and clinical outcomes following planned extubation. The aim was to determine the optimal post-extubation respiratory support strategy for reducing extubation failure in high-risk ICU patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Due to the nature of the interventions, blinding of participants and treating clinicians was not feasible. However, outcome assessors and data analysts were blinded to treatment allocation to minimize assessment bias.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years.
- •Received invasive mechanical ventilation for at least 24 hours.
- •Considered ready for planned extubation after successful completion of a spontaneous breathing trial.
- •High risk of extubation failure, defined by the presence of at least four of the following risk factors:
- •Age >65 years. APACHE II score >12 on the day of extubation. Body mass index >30 kg/m². Inadequate secretion management. Difficult or prolonged weaning. Two or more comorbidities. Acute heart failure requiring mechanical ventilation. Moderate-to-severe chronic obstructive pulmonary disease. Airway patency problems. Prolonged mechanical ventilation. Hypercapnia at the end of the spontaneous breathing trial.
Exclusion Criteria
- •Age <18 years.
- •Presence of a tracheostomy.
- •Accidental extubation.
- •Self-extubation.
- •Contraindication to noninvasive ventilation.
Arms & Interventions
NIV
Patients received noninvasive ventilation immediately after planned extubation according to the study protocol.
Intervention: NIV (Device)
HFNC
Patients received high-flow nasal cannula oxygen therapy immediately after planned extubation according to the study protocol.
Intervention: HFNC (Device)
Investigators
Koot Ahmad
lecturer of chest diseases
Benha University