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NCT Number: NCT06918288

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

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.

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Key information

Conditions

Respiratory Failure With Hypercapnia

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Banha Faculity of Medicine

Banhā, Elqalyoubea, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 :

  • 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

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).
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 72 hours and 7 days after extubation.

    frequency of re-intubation

Secondary outcomes

  1. ventilator-free days

    Time frame: 28 days post-randomization

    ventilator-free days at 28 days post-randomization

  2. duration of respiratory support after extubation.

    Time frame: 72 hours after extubation

    duration of respiratory support after extubation

  3. treatment failure and reintubation rate

    Time frame: during 48 hours after extubation.

    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).

  4. respiratory support related adverse events

    Time frame: 72 hours post extubation

    respiratory support related adverse events

  5. Delirium

    Time frame: 72 hours postextubation

    the incidence of delirium using RAAS (Richmond Agitation-sedation score)

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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