HypoxiaHONCHONCT03332433
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol
A study testing High-flow nasal cannula oxygenation in people with Hypoxia and Gastric Cancer, run by RenJi Hospital at 3 sites in China.
Trial summary
Hypoxia is the most common adverse events during sedated gastroscopy. In present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the hypoxia. At the same time the feasibility and safety will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia, Gastric Cancer, Esophagus Cancer
- What is being tested?
- High-flow nasal cannula oxygenation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,034 participants
- Where
- 3 sitesChina
- Study dates
- 10 Nov 2017to 30 Mar 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing gastroscope
- age over 18 years old
- Signed informed consent form
Who cannot join
- Coagulation disorders or a tendency of nose bleeding;
- An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;
- Severe aortic stenosis or mitral stenosis;
- Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;
- Acute myocardial infarction in the last 6 months;
- Acute arrhythmia (including any tachycardia - or bradycardia) with hemodynamic instability;
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- Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);
- Increased intracranial pressure;
- ASA >III;
- Mouth, nose, or throat infection;
- Fever, defined as core body temperature > 37.5oC ;
- Pregnancy, breastfeeding or positive pregnancy test
- Emergency procedure
Trial locations and contacts
3 sites in 1 country.
China3 sites
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200065
Renji hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai Municipality
About this study
Official title: High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol: a Randomized Multicentre Clinical Trial
Hypoxia is the most common adverse events during sedated gastroscopy. In present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the hypoxia. At the same time the feasibility and safety will be evaluated.
- Conditions
- Hypoxia, Gastric Cancer, Esophagus Cancer, Adverse Event
- Being tested
- High-flow nasal cannula oxygenation
- Keywords
- Hypoxia, Gastroscope, High-flow nasal cannula
- Medical subject headings
- Hypoxia, Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannula oxygenationDevice
Oxygen is supplied with a high-flow nasal cannula oxygenation device，the flow is up to 60L/min
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Oxygen(2L/min) supplied with nasal catheter |
| High-flow nasal cannula group | Experimental | Oxygen(up to 60L/min) supplied with high-flow nasal cannula Receives: Device: High-flow nasal cannula oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxia
(75% ≤ SpO2 < 90% for <60 s)
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes (3)
Incidence of subclinical respiratory depression
(90% ≤ SpO2 < 95%)
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Incidence of severe hypoxia
(SpO2 < 75% for any duration or 75% ≤ SpO2 < 90% for >/=60 s)
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other adverse events
Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start10 Nov 2017
- Primary completion28 Feb 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pudong New Area People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332433
- Sponsor's protocol ID
- RenJiH-20170724
- Acronym
- HONCHO
- Status last verified
- Sep 2018
- First submitted
- 26 Oct 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin Y, Zhang X, Li L, Wei M, Zhao B, Wang X, Pan Z, Tian J, Yu W, Su D. High-flow nasal cannula oxygen therapy and hypoxia during gastroscopy with propofol sedation: a randomized multicenter clinical trial. Gastrointest Endosc. 2019 Oct;90(4):591-601. doi: 10.1016/j.gie.2019.06.033. Epub 2019 Jul 3.
PubMed 31278907
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol: a Randomized Multicentre Clinical Trial
- ClinicalTrials.gov ID
- NCT03332433
- Acronym / sponsor ID
- HONCHO / RenJiH-20170724
- Conditions
- Hypoxia, Gastric Cancer, Esophagus Cancer, Adverse Event
- Keywords
- Hypoxia, Gastroscope, High-flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,034 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Pudong New Area People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 6 Nov 2017 (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.
Hypoxia is the most common adverse events during sedated gastroscopy. In present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the hypoxia. At the same time the feasibility and safety will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Oxygen(2L/min) supplied with nasal catheter |
| High-flow nasal cannula group | Experimental | Device: High-flow nasal cannula oxygenationOxygen(up to 60L/min) supplied with high-flow nasal cannula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing gastroscope
- age over 18 years old
- Signed informed consent form
Key exclusion criteria (13 listed)
- Coagulation disorders or a tendency of nose bleeding;
- An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;
- Severe aortic stenosis or mitral stenosis;
- Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;
- Acute myocardial infarction in the last 6 months;
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 cannula oxygenationOxygen is supplied with a high-flow nasal cannula oxygenation device，the flow is up to 60L/min | Device | High-flow nasal cannula group |
Primary outcome
Incidence of hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
(75% ≤ SpO2 < 90% for <60 s)
3 secondary outcomes
Incidence of subclinical respiratory depression
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Incidence of severe hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other adverse events
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Derived from this study: PubMed 31278907Lin Y, Zhang X, Li L, Wei M, Zhao B, Wang X, Pan Z, Tian J, Yu W, Su D. High-flow nasal cannula oxygen therapy and hypoxia during gastroscopy with propofol sedation: a randomized multicenter clinical trial. Gastrointest Endosc. 2019 Oct;90(4):591-601. doi: 10.1016/j.gie.2019.06.033. Epub 2019 Jul 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 oxygenation in people with Hypoxia and Gastric Cancer, run by RenJi Hospital at 3 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 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: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxia (time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours). 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 NCT03332433, which also lists 1 linked publication.
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 Sep 2018.