HypoxiaNCT05474287
SJOV vs. HFNO for Hypoxia During Procedural Sedation at High Altitudes
A study testing SJOV and HFNO in people with Hypoxia and High Altitude, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study aims to compare the effect of the use of supraglottic jet oxygenation and ventilation (SJOV) with high-flow nasal oxygen therapy (HFNO) on reducing the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients at high altitudes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, High Altitude
- What is being tested?
- SJOV and HFNO
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older;
- underwent routine gastrointestinal endoscopy under procedural sedation;
- consented to participate in this trial.
Who cannot join
- infection of the upper airway;
- anatomical abnormalities of the face, nose, and upper airway;
- coagulopathies;
- anticipated or known difficult airway;
- known allergy against propofol, soybeans, and egg;
- absence from the high-altitude environment during the past 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tibet autonomous region people's hospital
Lhasa, Tibet
Ciren Laba
About this study
Official title: Hypoxemia During Deep Sedation for Gastrointestinal Endoscopy at High Altitudes: High-flow Nasal Oxygen Therapy vs. Supraglottic Jet Oxygenation and Ventilation
This study aims to compare the effect of the use of supraglottic jet oxygenation and ventilation (SJOV) with high-flow nasal oxygen therapy (HFNO) on reducing the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients at high altitudes.
Read the detailed description
The participants will be randomly allocated to either SJOV or HFNO in a 1:1 ratio using block randomization with variable block sizes of four or six randomized. In the HFNO group, oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (FiO2) of 100%. In the SJOV group, SJOV is conducted using a Wei nasal jet tube (WNJ, Well Lead Medical Co. Ltd, Guangzhou, China) which is connected to a manual jet ventilator (Well Lead Medical Co. Ltd, Guangzhou, China) via its jet port. The initial settings of SJOV were as follows: driving pressure (DP) 15 psi; respiratory rate (RR) 20 bpm; inspiratory-to-expiratory (I/E) ratio 1:2, and gas supply, 100% oxygen.
- Conditions
- Hypoxia, High Altitude
- Being tested
- SJOV, HFNO
- Medical subject headings
- Hypoxia, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SJOVProcedure or surgery
SJOV is conducted using a Wei nasal jet tube (WNJ, Well Lead Medical Co. Ltd, Guangzhou, China) which is connected to a manual jet ventilator (Well Lead Medical Co. Ltd, Guangzhou, China) via its jet port. The initial settings of SJOV were as follows: driving pressure (DP) 15 psi; respiratory rate (RR) 20 bpm; inspiratory-to-expiratory (I/E) ratio 1:2, and gas supply, 100% oxygen.
HFNOProcedure or surgery
HFNO is conducted. Oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (FiO2) of 100%.
| Study group | Role | What they receive |
|---|---|---|
| Supraglottic jet oxygenation and ventilation | Experimental | Supraglottic jet oxygenation and ventilation is conducted for the participants during sedation. Receives: Procedure: SJOV |
| High-flow nasal oxygen therapy | Active comparator | High-flow nasal oxygen therapy is conducted for the participants during sedation. Receives: Procedure: HFNO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxia during sedation
An SPO2 of 75 - 89% for < 60 s
Measured: During sedation procedure
Secondary outcomes (3)
respiratory-related complications
pulmonary aspiration, respiratory depression (SPO2 = 90-95%) and severe hypoxia (SPO2 < 75% or < 90% for > 60s)
Measured: During sedation procedure
cardiovascular-related complications
hypotension (systolic blood pressure < 90 mmHg), hypertension (systolic blood pressure > 160 mmHg), bradycardia (heart rate < 50 beats/min), tachycardia (heart rate > 120 beats/min)
Measured: During sedation procedure
fatal complications
severe anaphylactic reactions, myocardial infarction, cardiac arrest and death
Measured: from sedation initiation to 20 min after patients are awake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start14 Oct 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (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 Peking University People's HospitalThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tibet Autonomous Region People's Hospital
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
- Investigators
- Yi Feng, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474287
- Sponsor's protocol ID
- XZ2022ZR-ZY11-Z
- Status last verified
- Oct 2022
- First submitted
- 22 Jul 2022
- Last updated
- 17 Oct 2022
- 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 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxemia During Deep Sedation for Gastrointestinal Endoscopy at High Altitudes: High-flow Nasal Oxygen Therapy vs. Supraglottic Jet Oxygenation and Ventilation
- ClinicalTrials.gov ID
- NCT05474287
- Acronym / sponsor ID
- XZ2022ZR-ZY11-Z
- Conditions
- Hypoxia, High Altitude
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Tibet Autonomous Region People's Hospital
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 26 Jul 2022 (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.
This study aims to compare the effect of the use of supraglottic jet oxygenation and ventilation (SJOV) with high-flow nasal oxygen therapy (HFNO) on reducing the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients at high altitudes.
Detailed description
The participants will be randomly allocated to either SJOV or HFNO in a 1:1 ratio using block randomization with variable block sizes of four or six randomized. In the HFNO group, oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (FiO2) of 100%. In the SJOV group, SJOV is conducted using a Wei nasal jet tube (WNJ, Well Lead Medical Co. Ltd, Guangzhou, China) which is connected to a manual jet ventilator (Well Lead Medical Co. Ltd, Guangzhou, China) via its jet port. The initial settings of SJOV were as follows: driving pressure (DP) 15 psi; respiratory rate (RR) 20 bpm; inspiratory-to-expiratory (I/E) ratio 1:2, and gas supply, 100% oxygen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supraglottic jet oxygenation and ventilation | Experimental | Procedure: SJOVSupraglottic jet oxygenation and ventilation is conducted for the participants during sedation. |
| High-flow nasal oxygen therapy | Active comparator | Procedure: HFNOHigh-flow nasal oxygen therapy is conducted for the participants during sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older;
- underwent routine gastrointestinal endoscopy under procedural sedation;
- consented to participate in this trial.
Key exclusion criteria (6 listed)
- infection of the upper airway;
- anatomical abnormalities of the face, nose, and upper airway;
- coagulopathies;
- anticipated or known difficult airway;
- known allergy against propofol, soybeans, and egg;
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 |
|---|---|---|
| SJOVSJOV is conducted using a Wei nasal jet tube (WNJ, Well Lead Medical Co. Ltd, Guangzhou, China) which is connected to a manual jet ventilator (Well Lead Medical Co. Ltd, Guangzhou, China) via its jet port. The initial settings of SJOV were as follows: driving pressure (DP) 15 psi; respiratory rate (RR) 20 bpm; inspiratory-to-expiratory (I/E) ratio 1:2, and gas supply, 100% oxygen. | Procedure or surgery | Supraglottic jet oxygenation and ventilation |
| HFNOHFNO is conducted. Oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (FiO2) of 100%. | Procedure or surgery | High-flow nasal oxygen therapy |
Primary outcome
Hypoxia during sedation
Time frame: During sedation procedure
An SPO2 of 75 - 89% for < 60 s
3 secondary outcomes
respiratory-related complications
Time frame: During sedation procedure
cardiovascular-related complications
Time frame: During sedation procedure
fatal complications
Time frame: from sedation initiation to 20 min after patients are awake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- 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. This study is not recruiting at the moment.
Yi Feng principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SJOV and HFNO in people with Hypoxia and High Altitude, run by Peking University People's Hospital 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 6 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: status not confirmed, as of the sponsor's last update on 17 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bailin Jiang (86-13810986114, jiangbailin@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxia during sedation (time frame: During sedation procedure). 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 17 Oct 2022.