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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Failure With Hypercapnia
• Intervention / Treatment: Device: High flow nasal canula; Device: Non-invasive positive pressure mechanical ventilation

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Elqalyoubea
    • Banha, Elqalyoubea, Egypt, 13511
      • Banha Faculity of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High flow nasal canula (HFNC) group.	Device: High flow nasal canula; 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.
Active Comparator: Non-invasive positive pressure mechanical ventilation (NIPPV) group.	Device: Non-invasive positive pressure mechanical ventilation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ventilator-free days	ventilator-free days at 28 days post-randomization	28 days post-randomization
duration of respiratory support after extubation.	duration of respiratory support after extubation	72 hours after extubation
treatment failure and reintubation rate	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).	during 48 hours after extubation.
respiratory support related adverse events	respiratory support related adverse events	72 hours post extubation
Delirium	the incidence of delirium using RAAS (Richmond Agitation-sedation score)	72 hours postextubation

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Study Director: Ahmed Mostafa Abdelhamid, Professor of Anesthesia, Faculty of Medicine, Benha University; Principal Investigator: Fatma Ahmed Abdelfattah, MD Anesthesia and intensive ca, Faculty of Medicine, Benha University; Study Chair: Mohamed Shaker Sadek, MD chest diseases, Faculty of Medicine, Benha University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: March 15, 2025
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Difficult weaning-hypoxia-hypercapnea-postextubation-reintubation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypercapnia
• Other Study ID Numbers: MD4-2-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Study Data/Documents

1. Clinical Study Report
   Information identifier: Arnaud W Thille et al
   Information comments: Extubation failure is associated with a poor prognosis, but the respective roles for reintubation per se and underlying disease severity remain unclear. Our objectives were to evaluate the impact of failed extubation, whether planned or unplanned, on patient outcomes and to identify a patient subset at risk for extubation failure.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No