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

Benha University

Status and phase: Active, not recruiting; Phase 2

Conditions: Respiratory Failure With Hypercapnia

Treatments: Device: High flow nasal canula; Device: Non-invasive positive pressure mechanical ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT06918288

MD4-2-2025

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

High flow nasal canula (HFNC) group.

Active Comparator group

Treatment:

Device: High flow nasal canula

Non-invasive positive pressure mechanical ventilation (NIPPV) group.

Active Comparator group

Treatment:

Device: Non-invasive positive pressure mechanical ventilation