Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients
Launched by JIAN-XIN ZHOU · Feb 6, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how two different types of high-flow oxygen therapy affect patients who have a tracheostomy, which is a procedure where a hole is created in the neck to help with breathing. The trial will compare standard high-flow oxygen delivered through a regular tube to a new modified tube that has a smaller opening. The researchers believe that the modified tube might work better by increasing pressure in the airways, which could help patients breathe more easily and improve their lung function.
To be eligible for this study, participants must be between 18 and 74 years old, have a tracheostomy, and be able to breathe on their own without serious complications. However, people with certain health issues, such as unstable blood pressure or recent surgeries, will not be able to take part. If you join the trial, you’ll receive both types of oxygen therapy at different times, allowing researchers to see which one works better for your breathing needs. This study is not yet recruiting participants, but it aims to provide valuable information that could improve care for patients needing oxygen therapy after a tracheostomy.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Tracheostomy with stable spontaneous breathing.
- 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