Critical CareNCT06816706
Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials
A study testing Modified high flow tracheal oxygen-40L/min, Standard high flow tracheal oxygen-40L/min and T-piece in people with Critical Care and Oxygen Therapy, run by Jian-Xin Zhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Oxygen Therapy, Mechanical Ventilation
- What is being tested?
- Modified high flow tracheal oxygen-40L/min, Standard high flow tracheal oxygen-40L/min and T-piece
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical ventilation for more than 24 hours
- Considered by the physicians for the readiness to wean and ready for spontaneous breathing trials
Who cannot join
- 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
Show all 9Show fewer
- Pneumothorax or placement of a chest drainage
- Contraindication to electrical impedance tomography (EIT) (implantable defibrillator)
- Anticipating withdrawal of life support
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038
Jian-Xin Zhou, MD, PhD, 8610 6392 6666, zhoujx.cn@icloud.com
Shan-Shan Xu, MD, 8618501219133, 1004496285@qq.com
About this study
Official title: Comparison of Physiological Effects of Two Types of High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials in Mechanically Ventilated Patients
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.
Read the detailed description
A spontaneous breathing trial (SBT) is a crucial step in the weaning and extubation process for assessing extubation tolerance. However, the optimal approach for conducting SBTs remains a topic of debate.
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
- Critical Care, Oxygen Therapy, Mechanical Ventilation
- Being tested
- Modified high flow tracheal oxygen-40L/min, Standard high flow tracheal oxygen-40L/min, T-piece, Modified high-flow tracheal oxygen-60L/min, Standard high-flow tracheal oxygen-60 L/min
- Keywords
- high-flow tracheal oxygen, T piece, spontaneous breathing trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified high flow tracheal oxygen-40L/minProcedure or surgery
Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed.
Standard high flow tracheal oxygen-40L/minProcedure or surgery
Standard high-flow tracheal oxygen with a flow rate of 40 L/min will be performed.
T-pieceProcedure or surgery
T-piece will be performed.
Modified high-flow tracheal oxygen-60L/minProcedure or surgery
Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed.
Standard high-flow tracheal oxygen-60 L/minProcedure or surgery
Standard high-flow tracheal oxygen with a flow rate of 60 L/min will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Modified high flow tracheal oxygen-40L/min | Experimental | Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials. Receives: Procedure: Modified high flow tracheal oxygen-40L/min |
| Standard high flow tracheal oxygen-40L/min | Experimental | Standard high-flow tracheal oxygen with a flow rate of 40L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials. Receives: Procedure: Standard high flow tracheal oxygen-40L/min |
| T-piece | Experimental | T-piece will be performed in mechanically ventilated patients undergoing spontaneous breathing trials. Receives: Procedure: T-piece |
| Modified high-flow tracheal oxygen-60L/min | Experimental | Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials. Receives: Procedure: Modified high-flow tracheal oxygen-60L/min |
| Standard high-flow tracheal oxygen-60L/min | Experimental | Standard high-flow tracheal oxygen with a flow rate of 60L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials. Receives: Procedure: Standard high-flow tracheal oxygen-60 L/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean expiratory airway pressure
Mean expiratory airway pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 4 hours
Secondary outcomes (8)
Respiratory rate
Respiratory rate will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Measured: From enrollment to the end of treatment at 4 hours
Tidal volume
Tidal volume will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Measured: From enrollment to the end of treatment at 4 hours
End-tidal carbon dioxide
End-tidal carbon dioxide will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Measured: From enrollment to the end of treatment at 4 hours
Pulse oxygen saturation
Pulse oxygen saturation will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Measured: From enrollment to the end of treatment at 4 hours
Esophageal pressure-time product
Esophageal pressure-time product will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Measured: From enrollment to the end of treatment at 4 hours
Tidal swing of esophageal pressure
Tidal swing of esophageal pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Measured: From enrollment to the end of treatment at 4 hours
Respiratory muscle pressure
Respiratory muscle pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Measured: From enrollment to the end of treatment at 4 hours
Dynamic transpulmonary pressure
Dynamic transpulmonary pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.
Measured: From enrollment to the end of treatment at 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Mar 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian-Xin Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, PhD, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816706
- Sponsor's protocol ID
- IIT2024-157-002
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu SS, Zhang RZ, Liu JT, Wang L, Hou MX, An X, Miao MY, Li HL, Wang YF, Zhou JX. Physiological comparison of high-flow oxygen via endotracheal tube and T-piece strategies during spontaneous breathing trials: a randomized crossover study. Crit Care. 2026 Aug 18;30(1):433. doi: 10.1186/s13054-026-06266-5.
PubMed 42618951Xu 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.
PubMed 40962338
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physiological Effects of Two Types of High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT06816706
- Acronym / sponsor ID
- IIT2024-157-002
- Conditions
- Critical Care, Oxygen Therapy, Mechanical Ventilation
- Keywords
- high-flow tracheal oxygen, T piece, spontaneous breathing trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jian-Xin ZhouUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A spontaneous breathing trial (SBT) is a crucial step in the weaning and extubation process for assessing extubation tolerance. However, the optimal approach for conducting SBTs remains a topic of debate.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Modified high flow tracheal oxygen-40L/min | Experimental | Procedure: Modified high flow tracheal oxygen-40L/minModified 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 | Experimental | Procedure: Standard high flow tracheal oxygen-40L/minStandard high-flow tracheal oxygen with a flow rate of 40L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials. |
| T-piece | Experimental | Procedure: T-pieceT-piece will be performed in mechanically ventilated patients undergoing spontaneous breathing trials. |
| Modified high-flow tracheal oxygen-60L/min | Experimental | Procedure: Modified high-flow tracheal oxygen-60L/minModified 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 | Experimental | Procedure: Standard high-flow tracheal oxygen-60 L/minStandard high-flow tracheal oxygen with a flow rate of 60L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mechanical ventilation for more than 24 hours
- Considered by the physicians for the readiness to wean and ready for spontaneous breathing trials
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified high flow tracheal oxygen-40L/minModified high-flow tracheal oxygen with a flow rate of 40L/min will be performed. | Procedure or surgery | Modified high flow tracheal oxygen-40L/min |
| Standard high flow tracheal oxygen-40L/minStandard high-flow tracheal oxygen with a flow rate of 40 L/min will be performed. | Procedure or surgery | Standard high flow tracheal oxygen-40L/min |
| T-pieceT-piece will be performed. | Procedure or surgery | T-piece |
| Modified high-flow tracheal oxygen-60L/minModified high-flow tracheal oxygen with a flow rate of 60L/min will be performed. | Procedure or surgery | Modified high-flow tracheal oxygen-60L/min |
| Standard high-flow tracheal oxygen-60 L/minStandard high-flow tracheal oxygen with a flow rate of 60 L/min will be performed. | Procedure or surgery | Standard high-flow tracheal oxygen-60L/min |
Primary outcome
Mean expiratory airway pressure
Time frame: 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 versus T-piece.
Positive end-expiratory pressure
Time frame: 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 versus T-piece.
Change of end-expiatory lung volume
Time frame: 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 versus T-piece.
8 secondary outcomes
Respiratory rate
Time frame: From enrollment to the end of treatment at 4 hours
Tidal volume
Time frame: From enrollment to the end of treatment at 4 hours
End-tidal carbon dioxide
Time frame: From enrollment to the end of treatment at 4 hours
Pulse oxygen saturation
Time frame: From enrollment to the end of treatment at 4 hours
Esophageal pressure-time product
Time frame: From enrollment to the end of treatment at 4 hours
Tidal swing of esophageal pressure
Time frame: From enrollment to the end of treatment at 4 hours
Respiratory muscle pressure
Time frame: From enrollment to the end of treatment at 4 hours
Dynamic transpulmonary pressure
Time frame: From enrollment to the end of treatment at 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 42618951Xu SS, Zhang RZ, Liu JT, Wang L, Hou MX, An X, Miao MY, Li HL, Wang YF, Zhou JX. Physiological comparison of high-flow oxygen via endotracheal tube and T-piece strategies during spontaneous breathing trials: a randomized crossover study. Crit Care. 2026 Aug 18;30(1):433. doi: 10.1186/s13054-026-06266-5.
- Derived from this study: PubMed 40962338Xu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian-Xin Zhou, MD, PhD principal investigator
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified high flow tracheal oxygen-40L/min, Standard high flow tracheal oxygen-40L/min and T-piece in people with Critical Care and Oxygen Therapy, run by Jian-Xin Zhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian-Xin Zhou, MD, PhD (8610 6392 6666, zhoujx.cn@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean expiratory airway pressure (time frame: From enrollment to the end of treatment at 4 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06816706, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.