Comparing high-flow tracheal oxygen and T-piece for breathing trials
Comparison of Physiological Effects of Two Types of High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials in Mechanically Ventilated Patients
This study is testing whether a new type of high-flow oxygen or a standard T-piece helps patients who are coming off mechanical ventilation breathe better during trials.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Capital Medical University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06816706 on ClinicalTrials.gov |
What this trial studies
This study evaluates the physiological effects of two types of high-flow tracheal oxygen compared to a T-piece during spontaneous breathing trials (SBT) in patients who have been mechanically ventilated. The researchers have developed a modified high-flow tracheal oxygen tube designed to enhance expiratory resistance and airway pressure, potentially improving the effectiveness of SBTs. Participants will be randomly assigned to receive either standard or modified high-flow tracheal oxygen or a T-piece, with key physiological parameters being measured throughout the trial. The goal is to determine which method provides the best support for patients transitioning from mechanical ventilation.
Who should consider this trial
Good fit: Ideal candidates are adults who have been on mechanical ventilation for over 24 hours and are deemed ready for spontaneous breathing trials.
Not a fit: Patients who are under 18 years old, pregnant, or have significant hemodynamic or respiratory instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the weaning process from mechanical ventilation, leading to better patient outcomes and reduced extubation failure rates.
How similar studies have performed: Previous studies have shown promising results with high-flow nasal oxygen, but the specific approach of modified high-flow tracheal oxygen is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Mechanical ventilation for more than 24 hours 2. Considered by the physicians for the readiness to wean and ready for spontaneous breathing trials Exclusion Criteria: 1. Age younger than 18 years old 2. Pregnancy 3. Hemodynamic instability (mean arterial pressure \<60 mmHg, heart rate \>140 or \<60 bpm) 4. Respiratory and oxygenation instability (respiratory rate \> 35bpm or oxygen saturation measured by pulse oximetry \<90%) 5. Neuromuscular diseases or phrenic nerve injury 6. Recent trauma or surgery to the trachea, esophagus, neck, chest, or stomach 7. Pneumothorax or placement of a chest drainage 8. Contraindication to electrical impedance tomography (EIT) (implantable defibrillator) 9. Anticipating withdrawal of life support
Where this trial is running
Beijing, Beijing Municipality
- Beijing Shijitan Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jian-Xin Zhou, MD, PhD — Capital Medical University
- Study coordinator: Jian-Xin Zhou, MD, PhD
- Email: zhoujx.cn@icloud.com
- Phone: 8610 6392 6666
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.