Critical CareNCT06816745
Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients
A study testing Modified high flow tracheal oxygen and Standard high flow tracheal oxygen in people with Critical Care and Oxygen Therapy, run by Jian-Xin Zhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Oxygen Therapy, Tracheostomy
- What is being tested?
- Modified high flow tracheal oxygen and Standard high flow tracheal oxygen
- 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
- 20 Feb 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
- Tracheostomy with stable spontaneous breathing.
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
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 Standard and Modified High-Flow Oxygen Therapy in Tracheostomized Patients
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.
Read the detailed description
High-flow nasal oxygen therapy 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. It has been widely utilized in managing acute hypoxemic respiratory failure and preventing hypoxemia after extubation.
High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. Previous studies have reported successful cases of using high-flow tracheal oxygen to facilitate weaning from prolonged mechanical ventilation in patients with restrictive and obstructive pulmonary disorders. 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, thus simulating the physiological effects of high-flow nasal cannula. This is a prospective randomized crossover physiological trial designed to compare the effects of standard and modified high-flow oxygen therapy in tracheostomized patients. Key physiological parameters will be assessed, including airway pressure, end-expiratory lung volume, vital signs, oxygenation, and respiratory workload.
- Conditions
- Critical Care, Oxygen Therapy, Tracheostomy
- Being tested
- Modified high flow tracheal oxygen, Standard high flow tracheal oxygen
- Keywords
- high-flow tracheal oxygen, tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified high flow tracheal oxygenProcedure or surgery
Modified high-flow tracheal oxygen with flow rates of 40L/min and 60L/min will be performed.
Standard high flow tracheal oxygenProcedure or surgery
Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Modified high flow tracheal oxygen | Experimental | Modified high-flow tracheal oxygen with flow rates of 40L/ min and 60L/min will be performed in tracheostomized patients. Receives: Procedure: Modified high flow tracheal oxygen |
| Standard high flow tracheal oxygen | Experimental | Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed in tracheostomized patients. Receives: Procedure: Standard high flow tracheal oxygen |
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 start20 Feb 2025 (estimated)
- 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.
- 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
- NCT06816745
- Sponsor's protocol ID
- IIT2024-158-002
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physiological Effects of Standard and Modified High-Flow Oxygen Therapy in Tracheostomized Patients
- ClinicalTrials.gov ID
- NCT06816745
- Acronym / sponsor ID
- IIT2024-158-002
- Conditions
- Critical Care, Oxygen Therapy, Tracheostomy
- Keywords
- high-flow tracheal oxygen, tracheostomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jian-Xin ZhouUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- 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.
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.
Detailed description
High-flow nasal oxygen therapy 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. It has been widely utilized in managing acute hypoxemic respiratory failure and preventing hypoxemia after extubation.
High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. Previous studies have reported successful cases of using high-flow tracheal oxygen to facilitate weaning from prolonged mechanical ventilation in patients with restrictive and obstructive pulmonary disorders. 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, thus simulating the physiological effects of high-flow nasal cannula. This is a prospective randomized crossover physiological trial designed to compare the effects of standard and modified high-flow oxygen therapy in tracheostomized patients. 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified high flow tracheal oxygen | Experimental | Procedure: Modified high flow tracheal oxygenModified high-flow tracheal oxygen with flow rates of 40L/ min and 60L/min will be performed in tracheostomized patients. |
| Standard high flow tracheal oxygen | Experimental | Procedure: Standard high flow tracheal oxygenStandard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed in tracheostomized patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Tracheostomy with stable spontaneous breathing.
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 oxygenModified high-flow tracheal oxygen with flow rates of 40L/min and 60L/min will be performed. | Procedure or surgery | Modified high flow tracheal oxygen |
| Standard high flow tracheal oxygenStandard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed. | Procedure or surgery | Standard high flow tracheal oxygen |
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.
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.
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.
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 10 Feb 2025.
- 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 and Standard high flow tracheal oxygen 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 1 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: opening soon, as of the sponsor's last update on 10 Feb 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?
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 10 Feb 2025.