Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials
Launched by JIAN-XIN ZHOU · Feb 6, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different methods of providing oxygen to patients who are ready to try breathing on their own after being on a ventilator. The trial aims to compare standard high-flow tracheal oxygen and a new modified version of it to a T-piece, which is a simple device used to deliver oxygen. Researchers want to see how these methods affect patients' breathing and overall lung function during a process called spontaneous breathing trials (SBT). This is important because it helps doctors decide if a patient is ready to be taken off the ventilator.
To be eligible for the trial, participants must be adults aged 18 or older who have been on mechanical ventilation for more than 24 hours and are considered ready to start breathing trials by their doctors. However, individuals with certain health issues, such as unstable heart conditions or specific respiratory problems, cannot participate. If you join the study, you'll receive either the standard or modified high-flow oxygen or the T-piece during the breathing trial, and the team will monitor how well you respond to each method. This trial is currently looking for volunteers, and your participation could help improve care for future patients in similar situations.
Gender
ALL
Eligibility 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
About Jian Xin Zhou
Jian-Xin Zhou is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on developing effective therapies across various therapeutic areas, the organization emphasizes rigorous scientific methodologies and ethical standards in all its studies. Jian-Xin Zhou collaborates with leading researchers and institutions to ensure the highest quality of clinical trials, aiming to bring breakthrough treatments to patients while prioritizing safety and efficacy. Through its strategic approach and commitment to excellence, Jian-Xin Zhou strives to make significant contributions to the healthcare landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, Beijing, China
Patients applied
Trial Officials
Jian-Xin Zhou, MD, PhD
Principal Investigator
Capital Medical University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported