Clinical trial NCT06918288: Post-extubation Nasal Humidified High-flow Oxygen Versus Non-invasive Positive Pressure Ventilation
Official title: Post-extubation Support Using Nasal Humidified High-flow Oxygen Versus Non-invasive Positive Pressure Mechanical Ventilation in Preventing Reintubation Among Patients With Type II Respiratory Failure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Respiratory Failure With Hypercapnia
Keywords: Difficult weaning-hypoxia-hypercapnea-postextubation-reintubation
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To apply postextubation NIV or HFNC to prevent reintubation
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

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

  4. 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.

Primary outcomes:
measure: The primary outcomes of this study will be the rate of re- intubation
timeFrame: 72 hours and 7 days after extubation.
Secondary outcomes:
measure: ventilator-free days
timeFrame: 28 days post-randomization
measure: duration of respiratory support after extubation.
timeFrame: 72 hours after extubation
measure: treatment failure and reintubation rate
timeFrame: during 48 hours after extubation.
measure: respiratory support related adverse events
timeFrame: 72 hours post extubation
measure: Delirium
timeFrame: 72 hours postextubation
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Banha Faculity of Medicine
state: Elqalyoubea
Study officials:
affiliation: faculty of medicine, Benha university
name: Ahmed Mostafa Abdelhamid, Professor of Anesthesia
role: STUDY_DIRECTOR
affiliation: faculty of medicine, Benha university
name: Fatma Ahmed Abdelfattah, MD Anesthesia and intensive ca
role: PRINCIPAL_INVESTIGATOR
affiliation: faculty of medicine, Benha university
name: Mohamed Shaker Sadek, MD chest diseases
role: STUDY_CHAIR
References:
citation: Thille AW, Harrois A, Schortgen F, Brun-Buisson C, Brochard L. Outcomes of extubation failure in medical intensive care unit patients. Crit Care Med. 2011 Dec;39(12):2612-8. doi: 10.1097/CCM.0b013e3182282a5a.
citation: Comellini V, Pacilli AMG, Nava S. Benefits of non-invasive ventilation in acute hypercapnic respiratory failure. Respirology. 2019 Apr;24(4):308-317. doi: 10.1111/resp.13469. Epub 2019 Jan 12.