Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials
1 other identifier
interventional
20
1 country
1
Brief Summary
Spontaneous breathing trials (SBT) are essential for assessing extubation tolerance, yet optimal approaches are debated. High-flow nasal oxygen offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. While high-flow tracheal oxygen can also be used as an SBT method, it has reduced physiological effects due to bypassing the upper airway with a more open circuit. To enhance this limitation, investigators developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase expiratory resistance and airway pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow tracheal oxygen versus T-piece during SBT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2025
CompletedFirst Posted
Study publicly available on registry
February 10, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedMarch 21, 2025
February 1, 2025
9 months
February 4, 2025
March 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Mean expiratory airway pressure
Mean expiratory airway pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
From enrollment to the end of treatment at 4 hours
Positive end-expiratory pressure
Positive end-expiratory pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
From enrollment to the end of treatment at 4 hours
Change of end-expiatory lung volume
Change of end-expiatory lung volume will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
From enrollment to the end of treatment at 4 hours
Secondary Outcomes (8)
Respiratory rate
From enrollment to the end of treatment at 4 hours
Tidal volume
From enrollment to the end of treatment at 4 hours
End-tidal carbon dioxide
From enrollment to the end of treatment at 4 hours
Pulse oxygen saturation
From enrollment to the end of treatment at 4 hours
Esophageal pressure-time product
From enrollment to the end of treatment at 4 hours
- +3 more secondary outcomes
Study Arms (5)
Modified high flow tracheal oxygen-40L/min
EXPERIMENTALModified high-flow tracheal oxygen with a flow rate of 40L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.
Standard high flow tracheal oxygen-40L/min
EXPERIMENTALStandard high-flow tracheal oxygen with a flow rate of 40L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.
T-piece
EXPERIMENTALT-piece will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.
Modified high-flow tracheal oxygen-60L/min
EXPERIMENTALModified high-flow tracheal oxygen with a flow rate of 60L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.
Standard high-flow tracheal oxygen-60L/min
EXPERIMENTALStandard high-flow tracheal oxygen with a flow rate of 60L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.
Interventions
Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed.
Standard high-flow tracheal oxygen with a flow rate of 40 L/min will be performed.
Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed.
Standard high-flow tracheal oxygen with a flow rate of 60 L/min will be performed.
Eligibility Criteria
You may qualify if:
- Mechanical ventilation for more than 24 hours
- Considered by the physicians for the readiness to wean and ready for spontaneous breathing trials
You may not qualify if:
- Age younger than 18 years old
- Pregnancy
- Hemodynamic instability (mean arterial pressure \<60 mmHg, heart rate \>140 or \<60 bpm)
- Respiratory and oxygenation instability (respiratory rate \> 35bpm or oxygen saturation measured by pulse oximetry \<90%)
- Neuromuscular diseases or phrenic nerve injury
- Recent trauma or surgery to the trachea, esophagus, neck, chest, or stomach
- Pneumothorax or placement of a chest drainage
- Contraindication to electrical impedance tomography (EIT) (implantable defibrillator)
- Anticipating withdrawal of life support
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jian-Xin Zhoulead
Study Sites (1)
Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038, China
Related Publications (1)
Xu SS, Zhang RZ, An X, Miao MY, Wang YF, Li HL, Zhou JX. Physiological effects of high-flow oxygen via endotracheal tube versus T-piece strategies during spontaneous breathing trials: a study protocol and statistical analysis for a single-centre randomised crossover study. BMJ Open. 2025 Sep 16;15(9):e105360. doi: 10.1136/bmjopen-2025-105360.
PMID: 40962338DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jian-Xin Zhou, MD, PhD
Capital Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 4, 2025
First Posted
February 10, 2025
Study Start
March 1, 2025
Primary Completion
November 30, 2025
Study Completion
December 30, 2025
Last Updated
March 21, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share