Comparing high-flow tracheal oxygen and T-piece for breathing trials

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.