Testing noninvasive ventilation methods for patients with acute respiratory failure
Noninvasive Ventilation Breathing Test Guiding Sequential Invasive and Noninvasive Ventilation Weaning of Patients With Acute Hypoxic Respiratory Failure: a Randomized, Multicenter, Controlled Trial
This study tests if a new breathing method can help patients with severe breathing problems come off ventilators safely and sooner than the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06574659 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a noninvasive ventilation breathing test compared to a standard spontaneous breathing trial in guiding the weaning process for patients with acute hypoxic respiratory failure. Patients will be randomly assigned to either the noninvasive ventilation protocol or the standard protocol after being intubated and receiving invasive mechanical ventilation for over 24 hours. The goal is to determine if the noninvasive approach can safely facilitate earlier extubation and reduce complications associated with prolonged invasive ventilation.
Who should consider this trial
Good fit: Ideal candidates are adult patients admitted to the ICU with acute hypoxic respiratory failure who require invasive mechanical ventilation.
Not a fit: Patients over 80 years old, those with severe comorbidities, or conditions that prevent cooperation with non-invasive ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery times and reduced complications for patients with acute hypoxic respiratory failure.
How similar studies have performed: Previous studies have shown that noninvasive ventilation can be beneficial in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients who have been admitted to the intensive care unit (ICU) with Acute Hypoxic Respiratory Failure. Oxygenation index less than 300mmHg, have undergone tracheal intubation, and are anticipated received invasive mechanical ventilation for more than 24 hours. Exclusion Criteria: * • Age over 80 years, * Pregnancy, * Consciousness disorders or intracranial hypertension caused by various reasons, * Neuromuscular disorders, * Severe cardiac dysfunction (New York Heart Association Class III or IV, acute coronary syndrome or persistent ventricular tachycardia), * Cardiogenic shock or after major cardiac surgery, * Severe liver and kidney failure, * Severe malnutrition, * Injury to the upper airway or nose and face, making it impossible to wear a nose (face) mask, * Severe agitation, Severe agitation, expected to be unable to cooperate with non-invasive mechanical ventilation.
Where this trial is running
Chengdu, Sichuan
- West China Hospital,Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Xiaoyi Liu — Department of Critical Care Medicine
- Study coordinator: Yongfang Zhou
- Email: zyfmg@163.com
- Phone: 86 18140212276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.