Noninvasive Ventilation Versus High-Flow Nasal Cannula After Extubation in High-Risk ICU Patients

NCT07630766 | Completed

• 1 other identifier: RC.16.7.2025
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Extubation Failure

Keywords

Noninvasive ventilation; high-flow nasal cannula; extubation failure; reintubation; ICU

Outcome Measures

Primary Outcomes (1)

• Reintubation Rate

  Proportion of patients requiring reintubation following planned extubation.

  7 days

Secondary Outcomes (1)

• Time to Reintubation

  7 days

Study Arms (2)

NIV

EXPERIMENTAL

Patients received noninvasive ventilation immediately after planned extubation according to the study protocol.

Device: NIV

HFNC

ACTIVE COMPARATOR

Patients received high-flow nasal cannula oxygen therapy immediately after planned extubation according to the study protocol.

Device: HFNC

Interventions

NIV DEVICE

NIV was initiated immediately after extubation using bilevel positive airway pressure delivered via a properly fitted face mask with active humidification using a Dräger Savina 300 ventilator (Drägerwerk AG \& Co. KGaA, Lübeck, Germany). Ventilator settings were adjusted to achieve a respiratory rate \<26 breaths/min, tidal volume of 6-8 mL/kg predicted body weight, and adequate oxygenation (SpO₂ ≥92%, pH ≥7.35). Sedation was not permitted.

NIV

HFNC DEVICE

HFNC was applied immediately after extubation using a heated humidified high-flow nasal cannula system (BioVent A-Series, Model: BioHF BB60101; BIO-AOI, Cairo, Egypt). Flow was initially set at 10 L/min and titrated up to 60 L/min according to patient tolerance. Gas temperature was maintained at 37°C. In both groups, FiO₂ was adjusted to maintain SpO₂ ≥92%. After 48 hours, respiratory support was discontinued and conventional oxygen therapy was provided if required. Rescue NIV was not allowed in the HFNC group. All patients received standardized care.

HFNC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \<18 years.
• Presence of a tracheostomy.
• Accidental extubation.
• Self-extubation.
• Contraindication to noninvasive ventilation.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of chest diseases

Model Details: Participants were randomly assigned in a parallel-group design to receive either noninvasive ventilation (NIV) or high-flow nasal cannula (HFNC) immediately after planned extubation. Outcomes were compared between the two groups during follow-up.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 5, 2026
• Study Start: July 30, 2025
• Primary Completion: April 30, 2026
• Study Completion: May 15, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)