Extubation Failure
Conditions
Keywords
Noninvasive ventilation, high-flow nasal cannula, extubation failure, reintubation, ICU
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.
Interventions
DEVICENIV
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.
DEVICEHFNC
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.
Sponsors
Benha University
Study design
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. Received invasive mechanical ventilation for at least 24 hours. 3. Considered ready for planned extubation after successful completion of a spontaneous breathing trial. 4. 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
1. Age \<18 years. 2. Presence of a tracheostomy. 3. Accidental extubation. 4. Self-extubation. 5. Contraindication to noninvasive ventilation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reintubation Rate | 7 days | Proportion of patients requiring reintubation following planned extubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reintubation | 7 days | Time elapsed from extubation to reintubation among patients requiring reintubation. |
Countries
Egypt
Outcome results
None listed