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

NCT06918288 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-04-09

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Benha University

    lead OTHER

Principal Investigators

  • Ahmed Mostafa Abdelhamid, Professor of Anesthesia · faculty of medicine, Benha university

  • Fatma Ahmed Abdelfattah, MD Anesthesia and intensive ca · faculty of medicine, Benha university

  • Mohamed Shaker Sadek, MD chest diseases · faculty of medicine, Benha university

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-10-01
Completion
2025-10-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06918288 on ClinicalTrials.gov