Gastric CancerHRISKNCT05510388
HFNO Reduces Hypoxia During Sedated Gastroscopy or Colonoscopy in High Risk Patients
A study testing High-flow nasal cannula oxygenation and Regular nasal cannula oxygenation in people with Gastric Cancer and Intestinal Cancer, run by RenJi Hospital at 2 sites in China.
Trial summary
The objective of this study is to observe the preventive effects of high flow nasal oxygenation on the incidence of hypoxia during gastroscopy or colonoscopy sedated with propofol in high-risk patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Intestinal Cancer, Intestine Adenoma
- What is being tested?
- High-flow nasal cannula oxygenation and Regular nasal cannula oxygenation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2022to 30 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranging from 18 to 80, both sexes
- Patients receiving selective gastroscopy or colonoscopy or gastroscopy and colonoscopy procedure
- ASA Ⅲ~Ⅳ
- 18 kg/m2<BMI<28kg/m2
- The anticipated operation time of the procedure shall be less than 30min.
- Patients should clearly understand and voluntarily participate in the study, with signed informed consent.
Who cannot join
- Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc. who can not tolerate high-flow nasal cannula.
- Patients diagnosed POCD
- Patients clearly identified difficult airway
- Patients with mechanical ventilation
- Patients with acute respiratory infection and asthma
- Patients with acute upper gastrointestinal hemorrhage accompanied by shock, severe anemia, gastrointestinal obstruction accompanied by retention of gastric contents
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- Patients with aortic stenosis and carotid stenosis
- Patients allergic to sedatives such as propofol
- Patients without civil capacity such as cognitive dysfunction
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Second Hospital Affiliated to Chongqing Medical University
Chongqing, Chongqing Municipality, 404100
He Huang
Henan Provincial people's hospital
Zhengzhou, Henan, 450000
Jiaqiang Zhang
About this study
Official title: High-flow Nasal Cannula Oxygenation Reduces the Incidence of Hypoxia During Gastroscopy or Colonoscopy Sedated With Propofol in High-risk Patients: a Multi Central Randomized Controlled Study
The objective of this study is to observe the preventive effects of high flow nasal oxygenation on the incidence of hypoxia during gastroscopy or colonoscopy sedated with propofol in high-risk patients.
- Conditions
- Gastric Cancer, Intestinal Cancer, Intestine Adenoma, Gastritis
- Being tested
- High-flow nasal cannula oxygenation, Regular nasal cannula oxygenation
- Keywords
- Gastroscopy, High-flow nasal oxygenation, Hypoxia, High-risk, Colonoscopy
- Medical subject headings
- Stomach Neoplasms, Intestinal Neoplasms, Gastritis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannula oxygenationDevice
The patients receive oxygen flow of 6L/min for preoxygenation with an high-flow canular oxygenation device before losing of conscious. Then, the oxygen flow is adjusted to 60L/min with the oxygen concentration of 100% and the temperature of 37℃ until the end of procedure.
Regular nasal cannula oxygenationDevice
The patients receive an oxygen flow of 6L/min for preoxygenation with a disposal regular nasal cannula until the end of procedure.
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal cannula oxygenation group | Experimental | Not described Receives: Device: High-flow nasal cannula oxygenation |
| Regular nasal cannula oxygenation group | Active comparator | Not described Receives: Device: Regular nasal cannula oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypoxia
Hypoxia refers to 75%≤SpO2<90%,<60S
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes (4)
The incidence of severe hypoxia
Severe hypoxia refers to SpO2<75% lasting for any time, or 75%≤SpO2<90%, ≥60s
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The incidence of subclinical respiratory depression
Subclinical respiratory depression refers to 90%≤ SpO2<95%
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other adverse events evaluated by the tool of World SIVA
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Complications related to high-flow nasal cannula
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 posted22 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510388
- Sponsor's protocol ID
- KY2022-116-B
- Acronym
- HRISK
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula Oxygenation Reduces the Incidence of Hypoxia During Gastroscopy or Colonoscopy Sedated With Propofol in High-risk Patients: a Multi Central Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05510388
- Acronym / sponsor ID
- HRISK / KY2022-116-B
- Conditions
- Gastric Cancer, Intestinal Cancer, Intestine Adenoma, Gastritis
- Keywords
- Gastroscopy, High-flow nasal oxygenation, Hypoxia, High-risk, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 22 Aug 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.
The objective of this study is to observe the preventive effects of high flow nasal oxygenation on the incidence of hypoxia during gastroscopy or colonoscopy sedated with propofol in high-risk 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 oxygenation group | Experimental | Device: High-flow nasal cannula oxygenation |
| Regular nasal cannula oxygenation group | Active comparator | Device: Regular nasal cannula oxygenation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ranging from 18 to 80, both sexes
- Patients receiving selective gastroscopy or colonoscopy or gastroscopy and colonoscopy procedure
- ASA Ⅲ~Ⅳ
- 18 kg/m2<BMI<28kg/m2
- The anticipated operation time of the procedure shall be less than 30min.
Key exclusion criteria (9 listed)
- Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc. who can not tolerate high-flow nasal cannula.
- Patients diagnosed POCD
- Patients clearly identified difficult airway
- Patients with mechanical ventilation
- Patients with acute respiratory infection and asthma
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 oxygenationThe patients receive oxygen flow of 6L/min for preoxygenation with an high-flow canular oxygenation device before losing of conscious. Then, the oxygen flow is adjusted to 60L/min with the oxygen concentration of 100% and the temperature of 37℃ until the end of procedure. | Device | High-flow nasal cannula oxygenation group |
| Regular nasal cannula oxygenationThe patients receive an oxygen flow of 6L/min for preoxygenation with a disposal regular nasal cannula until the end of procedure. | Device | Regular nasal cannula oxygenation group |
Primary outcome
The incidence of hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Hypoxia refers to 75%≤SpO2<90%,<60S
4 secondary outcomes
The incidence of severe hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The incidence of subclinical respiratory depression
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other adverse events evaluated by the tool of World SIVA
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Complications related to high-flow nasal cannula
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 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.
2 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 and Regular nasal cannula oxygenation in people with Gastric Cancer and Intestinal Cancer, run by RenJi Hospital at 2 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 6 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: status not confirmed, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wanfeng Liu (+8613817793010, liuwanfeng@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 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?
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 22 Aug 2022.