Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials
NCT ID: NCT06816706
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-03-01
2025-12-30
Brief Summary
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Detailed Description
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High-flow nasal oxygen has been shown to provide several physiological benefits, including precise control of the fraction of inspired oxygen, generation of flow-related positive end-expiratory pressure, increased end-expiratory lung volume, improved oxygenation, and enhanced carbon dioxide elimination. High-flow oxygen therapy can also be applied via an artificial airway as high-flow tracheal oxygen. Previous studies have identified this therapy as a potential alternative for SBTs. However, compared to high-flow nasal oxygen, high-flow tracheal oxygen exhibits significantly diminished physiological effects due to the bypassing of the narrow nasopharynx, glottis, and upper airway as well as a more open circuit.
To address this limitation, the investigators have developed a modified high-flow tracheal oxygen tube with a reduced expiratory end tube diameter. This modification aims to create higher expiratory resistance and airway pressure, thereby simulating the physiological effects of HFNC. This study is a prospective randomized crossover physiological study designed to compare the effects of standard and modified high-flow tracheal oxygen versus T-piece during spontaneous breathing trials. Key physiological parameters will be assessed, including airway pressure, end-expiratory lung volume, vital signs, oxygenation, and respiratory workload.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Modified high flow tracheal oxygen-40L/min
Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.
Modified high flow tracheal oxygen-40L/min
Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed.
Standard high flow tracheal oxygen-40L/min
Standard 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
Standard high-flow tracheal oxygen with a flow rate of 40 L/min will be performed.
T-piece
T-piece will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.
T-piece
T-piece will be performed.
Modified high-flow tracheal oxygen-60L/min
Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.
Modified high-flow tracheal oxygen-60L/min
Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed.
Standard high-flow tracheal oxygen-60L/min
Standard 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-60 L/min
Standard high-flow tracheal oxygen with a flow rate of 60 L/min will be performed.
Interventions
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Modified high flow tracheal oxygen-40L/min
Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed.
Standard high flow tracheal oxygen-40L/min
Standard high-flow tracheal oxygen with a flow rate of 40 L/min will be performed.
T-piece
T-piece will be performed.
Modified high-flow tracheal oxygen-60L/min
Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed.
Standard high-flow tracheal oxygen-60 L/min
Standard high-flow tracheal oxygen with a flow rate of 60 L/min will be performed.
Eligibility Criteria
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Inclusion Criteria
2. Considered by the physicians for the readiness to wean and ready for spontaneous breathing trials
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Jian-Xin Zhou
OTHER
Responsible Party
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Jian-Xin Zhou
Professor
Principal Investigators
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Jian-Xin Zhou, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Capital Medical University
Locations
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Beijing Shijitan Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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IIT2024-157-002
Identifier Type: -
Identifier Source: org_study_id
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