HypoxemiaNCT07563075
Effect of High-Flow Nasal Cannula Oxygen Therapy on Hypoxemia in Pediatric Sedated Bronchoscopy
A study testing High-flow nasal cannula and Regular Nasal Cannula in people with Hypoxemia and Pneumonia, run by Zhejiang University at 4 sites in China.
Trial summary
Due to children's lower oxygen reserves and higher oxygen consumption, sedation can easily lead to respiratory adverse events such as hypoxemia. It has been reported that the incidence of hypoxemia during pediatric bronchoscopy is high, highlighting that hypoxemia in pediatric painless bronchoscopy is an urgent… Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Hypoxemia, Pneumonia, Pulmonary Neoplasm
- What is being tested?
- High-flow nasal cannula and Regular Nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 4 sitesChina
- Study dates
- 1 Apr 2026to 31 Mar 2027
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1 year ≤ age ≤ 6 years,
- Weight ≥ 10 kg,
- Undergoing elective sedated bronchoscopy,
- Expected procedure duration ≤ 45 minutes,
- Written informed consent obtained from the subject's legal guardian.
Who cannot join
- preoperative SpO₂ < 95% on room air,
- Already sedated and tracheally intubated,
- Known history of pneumothorax, known congenital or acquired upper airway abnormalities (e.g., nasopharyngeal structural anomalies), or history of difficult airway,
- Coagulation disorders or predisposition to oral/nasal bleeding, mucosal injury, or space-occupying lesions,
- Severe cardiac insufficiency (< 4 METs), severe renal insufficiency (requiring dialysis), diagnosed severe hepatic insufficiency, Increased intracranial pressure, or ASA classification ≥ IV,
- Allergy to propofol or sufentanil,
Show all 9Show fewer
- Multiple traumatic injuries,
- Current participation in another clinical trial,
- Other conditions deemed unsuitable by the investigator.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Children's Hospital of Chongqing Medical University
Chongqing
Ping Xu
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Yue Jin
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Diansan Su, +86 18616514088, diansansu@yahoo.com
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 310000
Han Lin
About this study
Official title: Effect of High-Flow Nasal Cannula Oxygen Therapy on Hypoxemia in Pediatric Sedated Bronchoscopy: A Multicenter Randomized Controlled Trial
Due to children's lower oxygen reserves and higher oxygen consumption, sedation can easily lead to respiratory adverse events such as hypoxemia. It has been reported that the incidence of hypoxemia during pediatric bronchoscopy is high, highlighting that hypoxemia in pediatric painless bronchoscopy is an urgent problem requiring a solution. High-flow nasal cannula (HFNC) oxygen therapy delivers heated and humidified breathing gas with a precisely controllable oxygen concentration, at flow rates exceeding the patient's peak inspiratory flow, directly via unsealed nasal prongs. It is a simple, comfortable, effective, and non-invasive respiratory support method that has been widely adopted in clinical practice. However, the effectiveness of HFNC in pediatric sedation remains unclear. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxemia during sedated bronchoscopy in pediatric patients.
- Conditions
- Hypoxemia, Pneumonia, Pulmonary Neoplasm
- Being tested
- High-flow nasal cannula, Regular Nasal Cannula
- Keywords
- Bronchoscopy, Hypoxemia, Sedation, Pediatric, High-flow nasal cannula
- Medical subject headings
- Hypoxia, Pneumonia, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannulaDevice
Using High-flow nasal cannula oxygenation
Regular Nasal CannulaDevice
Using regular nasal cannula for oxygenation
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal cannula Group | Experimental | Not described Receives: Device: High-flow nasal cannula |
| Regular Nasal Cannula Group | Active comparator | Not described Receives: Device: Regular Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypoxemia
75% ≤ SpO2 < 90% for <60 s
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Secondary outcomes (4)
The incidence of sub-clinical respiratory depression
90% ≤ SpO2 < 95%
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of severe hypoxia
SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of Other Adverse Events (Excluding Respiratory-Related)
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of Other Respiratory-Related Adverse Events
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diansan Su, Zhejiang University
- Investigators
- Diansan Su, Study chair, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563075
- Sponsor's protocol ID
- ZJU2025C226
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Flow Nasal Cannula Oxygen Therapy on Hypoxemia in Pediatric Sedated Bronchoscopy: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07563075
- Acronym / sponsor ID
- ZJU2025C226
- Conditions
- Hypoxemia, Pneumonia, Pulmonary Neoplasm
- Keywords
- Bronchoscopy, Hypoxemia, Sedation, Pediatric, High-flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 1 May 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.
Due to children's lower oxygen reserves and higher oxygen consumption, sedation can easily lead to respiratory adverse events such as hypoxemia. It has been reported that the incidence of hypoxemia during pediatric bronchoscopy is high, highlighting that hypoxemia in pediatric painless bronchoscopy is an urgent problem requiring a solution. High-flow nasal cannula (HFNC) oxygen therapy delivers heated and humidified breathing gas with a precisely controllable oxygen concentration, at flow rates exceeding the patient's peak inspiratory flow, directly via unsealed nasal prongs. It is a simple, comfortable, effective, and non-invasive respiratory support method that has been widely adopted in clinical practice. However, the effectiveness of HFNC in pediatric sedation remains unclear. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxemia during sedated bronchoscopy in pediatric patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal cannula Group | Experimental | Device: High-flow nasal cannula |
| Regular Nasal Cannula Group | Active comparator | Device: Regular Nasal Cannula |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 1 year ≤ age ≤ 6 years,
- Weight ≥ 10 kg,
- Undergoing elective sedated bronchoscopy,
- Expected procedure duration ≤ 45 minutes,
- Written informed consent obtained from the subject's legal guardian.
Key exclusion criteria (9 listed)
- preoperative SpO₂ < 95% on room air,
- Already sedated and tracheally intubated,
- Known history of pneumothorax, known congenital or acquired upper airway abnormalities (e.g., nasopharyngeal structural anomalies), or history of difficult airway,
- Coagulation disorders or predisposition to oral/nasal bleeding, mucosal injury, or space-occupying lesions,
- Severe cardiac insufficiency (< 4 METs), severe renal insufficiency (requiring dialysis), diagnosed severe hepatic insufficiency, Increased intracranial pressure, or ASA classification ≥ IV,
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 |
|---|---|---|
| High-flow nasal cannulaUsing High-flow nasal cannula oxygenation | Device | High-flow nasal cannula Group |
| Regular Nasal CannulaUsing regular nasal cannula for oxygenation | Device | Regular Nasal Cannula Group |
Primary outcome
The incidence of hypoxemia
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
75% ≤ SpO2 < 90% for <60 s
4 secondary outcomes
The incidence of sub-clinical respiratory depression
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of severe hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of Other Adverse Events (Excluding Respiratory-Related)
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of Other Respiratory-Related Adverse Events
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 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 1 May 2026.
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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.
Diansan Su study chair
First Affiliated Hospital of Zhejiang University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow nasal cannula and Regular Nasal Cannula in people with Hypoxemia and Pneumonia, run by Zhejiang University at 4 sites 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 5 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Diansan Su (+86 18616514088, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hypoxemia (time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours). 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 1 May 2026.