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

NCT06918288 | Active Not Recruiting Phase 2

• 1 other identifier: MD4-2-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure With Hypercapnia

Keywords

Difficult weaning-hypoxia-hypercapnea-postextubation-reintubation

Outcome Measures

Primary Outcomes (1)

• The primary outcomes of this study will be the rate of re- intubation

  frequency of re-intubation

  72 hours and 7 days after extubation.

Secondary Outcomes (5)

• ventilator-free days

  28 days post-randomization

• duration of respiratory support after extubation.

  72 hours after extubation

• treatment failure and reintubation rate

  during 48 hours after extubation.

• respiratory support related adverse events

  72 hours post extubation

• Delirium

  72 hours postextubation

Study Arms (2)

High flow nasal canula (HFNC) group.

ACTIVE COMPARATOR

Device: High flow nasal canula

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

ACTIVE COMPARATOR

Device: Non-invasive positive pressure mechanical ventilation

Interventions

High flow nasal canula DEVICE

All patients assigned to the HFNC group will receive HFNC immediately after extubation. Researchers will need to choose the suitable size nasal catheter. The initial airflow will be set to 50 L/min and adjusted according to patient tolerance with an absolute humidity setting to 44 mgH2O/L and the temperature setting to 37 °C.The patient's respiratory rate will be maintained below 30 beats/min or the baseline level before extubation with a SpO2 at 88-92%. HFNC failure is defined as escalation to NIV or invasive mechanical ventilation due to respiratory failure.

High flow nasal canula (HFNC) group.

Non-invasive positive pressure mechanical ventilation DEVICE

All patients assigned to the control group will receive NIV immediately after extubation. Researchers will use a standard oronasal mask to connect the patient to the ventilator. The patients will be on Spontaneous/Timed (S/T) mode, with the initial end-expiratory pressure setting to 4 cmH2O. The pressure level will gradually increase to ensure that the patients can trigger the ventilator with each inhalation. The initial inspiratory pressure will be set at 8 cmH2O and adjusted according to the tidal volume with 6-8 ml/kg and tolerance of patients. The pres- sure level and the fraction of inspiration oxygen will be adjusted in order to maintain the respiratory rate ≤ 30/ min or the baseline level before extubation, a partial pressure of carbon dioxide (PaCO2) at 45-60 mmHg or the last PaCO2 level recorded before extubation, and a pulse oxygen saturation at 88-92%. NIV treatment failure is defined as a return to invasive mechanical ventilation.

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Lack of informed consent. 2. A contraindication to NIV (oral and facial trauma, excessive phlegm with poor expectoration ability, hemodynamic instability, recent esophageal surgery).
• \. Patients with poor short-term prognosis (very high risk of death within seven days or receiving palliative care).
• \. 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha Faculity of Medicine

Banhā, Elqalyoubea, 13511, Egypt

Location

Related Publications (2)

• 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.

  PMID: 21765357 BACKGROUND

• 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.

  PMID: 30636373 BACKGROUND

Related Links

• Related Info
• Related Info

Study Officials

• Ahmed Mostafa Abdelhamid, Professor of Anesthesia

  faculty of medicine, Benha university

  STUDY DIRECTOR

• Fatma Ahmed Abdelfattah, MD Anesthesia and intensive ca

  faculty of medicine, Benha university

  PRINCIPAL INVESTIGATOR

• Mohamed Shaker Sadek, MD chest diseases

  faculty of medicine, Benha university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: To apply postextubation NIV or HFNC to prevent reintubation

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: April 9, 2025
• Study Start: March 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 30, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

EG (1)