Post-extubation Nasal Humidified High-flow Oxygen Versus Non-invasive Positive Pressure Ventilation

Phase 2

Active, not recruiting

• Conditions: Respiratory Failure With Hypercapnia

• Registration Number: NCT06918288
• Lead Sponsor: Benha University

Brief Summary

Acute hypercapnic respiratory failure (AHRF), which is commonly defined as arterial partial pressure of carbon dioxide (PaCO2) ≥ 45 mmHg and frequently accompanied by reduced levels of arterial partial pressure of oxygen (PaO2), can occur in a variety of etiologies, mainly in chronic respiratory diseases, such as exacerbation of chronic obstructive pulmonary disease, cystic fibrosis, thoracic deformities, as well as other conditions, such as neuromuscular disease The purpose of this research is to To compare efficacy of administration of high flow nasal canula versus non-invasive mechanical ventilation on preventing reintubation during 72 hours postextubation of patients with type 2 respiratory failure with difficult weaning.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-01
• Study First Submitted: 2025-03-15
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-06
• Last Update Submitted: 2025-04-06
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• The study will be recruited on type II respiratory failure patients with difficult weaning from invasive mechanical. Patients who will fulfil the eligibility criteria will be randomly divided into HFNC or NIV groups to receive sequential treatment after extubation.

Hypercapnic respiratory failure is defined as an elevation in PaCO2 greater than 45 mmHg and a pH lower than 7.35 resulting from respiratory pump failure and/or production.

Type 2 respiratory failure common causes :

1. Neuromuscular Disorders such as: Amyotrophic lateral sclerosis (ALS), Myasthenia gravis, Muscular dystrophy.
2. Spinal cord injuries or damage to the spinal cord that can impair respiratory function.
3. Pulmonary Disorders Like Chronic obstructive pulmonary disease (COPD) ,Cystic fibrosis, Pneumonia Severe infection can cause respiratory failure , Pulmonary embolism.
4. Obesity and Sleep-Related Disorders like Obesity hypoventilation syndrome (OHS), obstructive sleep apnea(OSA).
5. Chest Wall and Pleural Disorders as Kyphoscoliosis, Pleural effusion, Pneumothorax.
6. Other Causes: Sedative overdose, Neurological disorders, high altitude

Exclusion Criteria

• 1. Lack of informed consent. 2. A contraindication to NIV (oral and facial trauma, excessive phlegm with poor expectoration ability, hemodynamic instability, recent esophageal surgery).

  2. Patients with poor short-term prognosis (very high risk of death within seven days or receiving palliative care).

  3. Other organs' failure e.g severe heart, brain, liver, or kidney failure. 5. Tracheostomised patients. 6. Loss of follow up and uncertain 28 day survival.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcomes of this study will be the rate of re- intubation	72 hours and 7 days after extubation.	frequency of re-intubation

Secondary Outcome Measures

Name	Time	Method
ventilator-free days	28 days post-randomization	ventilator-free days at 28 days post-randomization
duration of respiratory support after extubation.	72 hours after extubation	duration of respiratory support after extubation
respiratory support related adverse events	72 hours post extubation	respiratory support related adverse events
Delirium	72 hours postextubation	the incidence of delirium using RAAS (Richmond Agitation-sedation score)
treatment failure and reintubation rate	during 48 hours after extubation.	treatment failure rate (including reintubation rate and replacement of respiratory support: for patients in the HFNC group, treatment failure means to upgrade to NIV or invasive mechanical ventilation; for patients in the NIV group, treatment failure means to change to invasive mechanical ventilation).

Trial Locations

Locations (1)

Banha Faculity of Medicine; 🇪🇬 Banha, Elqalyoubea, Egypt