Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT06816745
Starting soon Not applicable

Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients

NCT06816745 · tracked via the Priya Life Science China tracker
Sponsor
Jian-Xin Zhou
Phase
Not applicable
Started
2025-02-20
Last updated
2025-02-10

Condition(s) studied

Critical CareOxygen TherapyTracheostomy

Investigational drug(s) / intervention(s)

Modified high flow tracheal oxygenStandard high flow tracheal oxygen

Modified high flow tracheal oxygen: Modified high-flow tracheal oxygen with flow rates of 40L/min and 60L/min will be performed.

Standard high flow tracheal oxygen: Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed.

Study summary

High-flow nasal oxygen therapy offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. While high-flow tracheal oxygen has been used to facilitate weaning, it has diminished physiological effects due to bypassing upper airways. To enhance its effectiveness, researchers developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase airway resistance and pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow oxygen therapy in tracheostomized patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Mean expiratory airway pressure — From enrollment to the end of treatment at 4 hours
    Mean expiratory airway pressure will be measured during standard and modified high-flow tracheal oxygen.
  • Positive end-expiratory pressure — From enrollment to the end of treatment at 4 hours
    Positive end-expiratory pressure will be measured during standard and modified high-flow tracheal oxygen.
  • Change of end-expiatory lung volume — From enrollment to the end of treatment at 4 hours
    Change of end-expiatory lung volume will be measured during standard and modified high-flow tracheal oxygen.

Trial sites (1)

FacilityCityRegionStatus
Beijing Shijitan Hospital Beijing Beijing Municipality

More Jian-Xin Zhou trials in China

Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments Recruiting
Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation Starting soon
Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure-Targeted Assist/Control Ventilation Starting soon
Pulmonary Microbiota Changes and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways Recruiting
Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials Recruiting

Other trials for the same condition

SV With TTPEE Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients Recruiting
Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments Recruiting
A Speaking-Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness Enrolling by invitation
A Pilot Trial of Pressure Muscle Index-Targeted PSV Trial Recruiting
Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06816745 on ClinicalTrials.gov ↗ ← All trials in China