HypoxiaNCT07389083
The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation for Deep Sedation Fiberoptic Bronchoscopy
A study testing wire-reinforced tracheal tube in people with Hypoxia and Pulmonary Nodule, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Bronchoscopy is now widely used for the diagnosis and treatment of various respiratory diseases. However, the procedure is highly stimulating and provokes a strong stress response; because the airway is shared, patients are prone to hypoxia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia, Pulmonary Nodule, Pulmonary Infection
- What is being tested?
- wire-reinforced tracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2025to 30 Mar 2026
- 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
- Undergoing fiberoptic bronchoscopy under deep sedation.
- Written informed consent obtained from the patient or their legal representative.
- Clear understanding of, and voluntary participation in, the study, with informed-consent form signed by the patient or their legal representative.
Who cannot join
- Age < 18 years
- BMI > 30 kg/m²
- Previous history of abnormal recovery from anesthesia/surgery
- History of recurrent epistaxis, nasal bone fracture, nasal polyps, or sinus surgery
- Chronic use of opioid analgesics, benzodiazepine hypnotics, or antidepressant medications
- Known allergy to any of the anesthetic agents employed
Show all 13Show fewer
- Anticipated difficult airway
- Increased intracranial pressure
- Active upper-respiratory-tract infection of the oral, nasal, or pharyngeal regions
- Severe cardiac insufficiency (functional capacity < 4 METs)
- Severe renal failure requiring dialysis prior to surgery
- Pre-operative oxygen saturation on room air < 92 %
- Any condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this trial
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
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Yeke Zhu, +8613515815457, 21618018@zju.edu.cn
21618018@zju.edu.cn
About this study
Official title: The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation Reduce the Incidence of Hypoxia in Patients Undergoing Sedated Fiberoptic Bronchoscopy.
Bronchoscopy is now widely used for the diagnosis and treatment of various respiratory diseases. However, the procedure is highly stimulating and provokes a strong stress response; because the airway is shared, patients are prone to hypoxia. With the growing emphasis on comfortable care, demand for anesthesia during bronchoscopy has increased. Deep sedation is the most common approach, but when administered in the supine position it often causes the tongue base to fall back. Both nasopharyngeal and oropharyngeal airways can relieve this obstruction, yet neither connects seamlessly to an oxygen supply line, resulting in insufficient oxygen delivery.We therefore replaced the nasopharyngeal airway with a wired endotracheal tube (size 4.0 or 4.5) inserted via the nose. This thinner tube couples easily to an oxygen line or ventilator circuit, partially relieves airway obstruction, and allows ample supraglottic oxygenation. The present study was designed to evaluate the feasibility and safety of this modified oxygen-delivery method in patients undergoing deep sedation for bronchoscopy.
- Conditions
- Hypoxia, Pulmonary Nodule, Pulmonary Infection
- Being tested
- wire-reinforced tracheal tube
- Keywords
- fiberoptic bronchoscopy, Hypoxia, Deep sedation, supine position, tongue-base fallback, supraglottic oxygenation
- Medical subject headings
- Hypoxia, Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wire-reinforced tracheal tubeDevice
Supraglottic oxygen therapy delivered via wire-reinforced nasotracheal tube
| Study group | Role | What they receive |
|---|---|---|
| Supraglottic oxygenation via nasotracheal catheterization Airway Group | Other | In this group, patients received supraglottic oxygen therapy via nasotracheal intubation. Receives: Device: wire-reinforced tracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）
Measured: Periprocedural
Secondary outcomes (2)
The incidence of sub-clinical respiratory depression(90% ≤ SpO2 < 95%)
Measured: Periprocedural
The incidence of severe hypoxia(SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s)
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start28 Dec 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yueying Zheng, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389083
- Sponsor's protocol ID
- ZJU2025C180
- Status last verified
- Nov 2025
- First submitted
- 31 Dec 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation Reduce the Incidence of Hypoxia in Patients Undergoing Sedated Fiberoptic Bronchoscopy.
- ClinicalTrials.gov ID
- NCT07389083
- Acronym / sponsor ID
- ZJU2025C180
- Conditions
- Hypoxia, Pulmonary Nodule, Pulmonary Infection
- Keywords
- fiberoptic bronchoscopy, Hypoxia, Deep sedation, supine position, tongue-base fallback, supraglottic oxygenation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 28 Dec 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 5 Feb 2026 (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.
Bronchoscopy is now widely used for the diagnosis and treatment of various respiratory diseases. However, the procedure is highly stimulating and provokes a strong stress response; because the airway is shared, patients are prone to hypoxia. With the growing emphasis on comfortable care, demand for anesthesia during bronchoscopy has increased. Deep sedation is the most common approach, but when administered in the supine position it often causes the tongue base to fall back. Both nasopharyngeal and oropharyngeal airways can relieve this obstruction, yet neither connects seamlessly to an oxygen supply line, resulting in insufficient oxygen delivery.We therefore replaced the nasopharyngeal airway with a wired endotracheal tube (size 4.0 or 4.5) inserted via the nose. This thinner tube couples easily to an oxygen line or ventilator circuit, partially relieves airway obstruction, and allows ample supraglottic oxygenation. The present study was designed to evaluate the feasibility and safety of this modified oxygen-delivery method in patients undergoing deep sedation for bronchoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supraglottic oxygenation via nasotracheal catheterization Airway Group | Other | Device: wire-reinforced tracheal tubeIn this group, patients received supraglottic oxygen therapy via nasotracheal intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing fiberoptic bronchoscopy under deep sedation.
- Written informed consent obtained from the patient or their legal representative.
- Clear understanding of, and voluntary participation in, the study, with informed-consent form signed by the patient or their legal representative.
Key exclusion criteria (13 listed)
- Age < 18 years
- BMI > 30 kg/m²
- Previous history of abnormal recovery from anesthesia/surgery
- History of recurrent epistaxis, nasal bone fracture, nasal polyps, or sinus surgery
- Chronic use of opioid analgesics, benzodiazepine hypnotics, or antidepressant medications
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 |
|---|---|---|
| wire-reinforced tracheal tubeSupraglottic oxygen therapy delivered via wire-reinforced nasotracheal tube | Device | Supraglottic oxygenation via nasotracheal catheterization Airway Group |
Primary outcome
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）
Time frame: Periprocedural
2 secondary outcomes
The incidence of sub-clinical respiratory depression(90% ≤ SpO2 < 95%)
Time frame: Periprocedural
The incidence of severe hypoxia(SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s)
Time frame: Periprocedural
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 5 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wire-reinforced tracheal tube in people with Hypoxia and Pulmonary Nodule, run by First Affiliated Hospital of Zhejiang University 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 3 inclusion and 13 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 5 Feb 2026. 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 Yueying Zheng (+8613777408863, 1507128@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s） (time frame: Periprocedural). 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 5 Feb 2026.