Gastric CancerNCT05526339
HFNO Combined With NPA Reduces Hypoxia During Sedated Gastrointestinal Endoscopy In Obese Patients
A study testing High-flow nasal oxygenation combined with nasopharyngeal airway and Regular nasal cannula combined with nasopharyngeal airway in people with Gastric Cancer and Gastric Ulcer, run by RenJi Hospital at 2 sites in China.
Trial summary
Obesity is associated with adverse airway events including desaturation during deep sedation. Previous studies have suggested that high-flow nasal oxygenation may be superior to regular (low-flow) nasal cannula for prevention of hypoxia during Sedated Gastrointestinal Endoscopy in non-obesity patients. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Gastric Cancer, Gastric Ulcer, Intestinal Cancer
- What is being tested?
- High-flow nasal oxygenation combined with nasopharyngeal airway and Regular nasal cannula combined with nasopharyngeal airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2022to May 2024
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving selective combined upper intestinal and lower intestinal endoscopy procedure under deep sedation.
- Age ranging from 19 to 80, both male and female
- Obese patients，BMI ≥ 28kg/m^2
- ASA I~III
- Patients should clearly understand and voluntarily participate in the study, with signed informed consent.
Who cannot join
- Patients with acute respiratory infection in the last 2 weeks
- Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery
- hypoxia, defined as oxygen saturation measured by pulse oximetry (SpO2) ≤ 95% before preoxygenation.
- Common advanced gastrointestinal endoscopy procedures meeting eligibility criteria included cholangiopancreatography, endoscopic ultrasound procedures, endoscopic mucosal resection and endoscopic retrograde cholangiopancreatography (ERCP) procedures.
- coagulation disorders or platelets < 100*10^9/L
- Have serious heart diseases such as severe arrhythmia, heart failure, Adams Stokes Disease, unstable angina pectoris, myocardial infarction in the last 6 months, history of tachycardia / bradycardia requiring medical treatment, third degree atrioventricular block or QTC interval ≥ 450ms (corrected according to fridericia's formula), or exercise tolerance < 4mets
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- Allergy to eggs, soy products, opioids and other drugs, propofol, etc.
- Participated in other clinical trials as a subject within 3 months
- Patients with brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, schizophrenia, intellectual disability, mania, psychosis, long-term use of psychotropic drugs, drug addiction, cognitive dysfunction history, etc.
- Emergency procedure
- Pregnant or breast-feeding women
- Patients having procedures with planned tracheal intubation or laryngeal mask
- Investigator considers the patients are inappropriate to participate in this trial
Trial locations and contacts
2 sites in 1 country.
China2 sites
Dushu Lake Hospital Affiliated to Soochow University
Suzhou, Jiangsu, 215000
Second Hospital Affiliated to Soochow University
Suzhou, Jiangsu, 215000
Jiang Zhu
About this study
Official title: High-Flow Nasal Oxygenation Combined With Nasopharyngeal Airway Reduces The Incidence Of Hypoxia During Gastrointestinal Endoscopy Sedated With Propofol In Obese Patients: A Prospective, Randomized Clinical Trial
Obesity is associated with adverse airway events including desaturation during deep sedation. Previous studies have suggested that high-flow nasal oxygenation may be superior to regular (low-flow) nasal cannula for prevention of hypoxia during Sedated Gastrointestinal Endoscopy in non-obesity patients. The prerequisite of high-flow nasal oxygenation is keeping airway patency. Our pervious study demonstrated that nasopharyngeal airway has the similar efficacy of jaw-lift. In present study we aimed to determine whether high-flow nasal oxygenation combined with nasopharyngeal airway could reduce the incidence of hypoxia during Sedated Gastrointestinal Endoscopy in obese patients.
- Conditions
- Gastric Cancer, Gastric Ulcer, Intestinal Cancer, Intestinal Polyps
- Being tested
- High-flow nasal oxygenation combined with nasopharyngeal airway, Regular nasal cannula combined with nasopharyngeal airway
- Keywords
- High-flow nasal oxygenation, Gastrointestinal endoscopy, Hypoxia
- Medical subject headings
- Stomach Neoplasms, Stomach Ulcer, Intestinal Neoplasms, Intestinal Polyps, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal oxygenation combined with nasopharyngeal airwayDevice
The patients receive an oxygen flow of 30 L/min for preoxygenation with a high-flow oxygenation device before losing of conscious. At the time of the abolition of the eyelash reflex, the gas flow was increased to 60 L/min with an inspired oxygen fraction 100% and the nasopharyngeal airway was placed.
Regular nasal cannula combined with nasopharyngeal airwayDevice
The patients receive an oxygen flow of 6 L/min for preoxygenation with a regular nasal cannula until the end of procedure. At the time of abolition of the eyelash reflex, the nasopharyngeal airway was placed.
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal oxygenation combined with nasopharyngeal airway | Experimental | High-flow nasal oxygenation combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol. Receives: Device: High-flow nasal oxygenation combined with nasopharyngeal airway |
| Regular nasal cannula combined with nasopharyngeal airway | Active comparator | Regular nasal cannula combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol. Receives: Device: Regular nasal cannula combined with nasopharyngeal airway |
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 (3)
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
The incidence of other adverse events
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 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 posted2 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (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
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Soochow University, Dushu Lake Hospital Affiliated to Soochow University
- Responsible party
- Sponsor
- Investigators
- Diansan Su, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526339
- Sponsor's protocol ID
- LY2022-018-A
- Status last verified
- Aug 2022
- First submitted
- 31 Aug 2022
- Last updated
- 2 Sep 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 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Flow Nasal Oxygenation Combined With Nasopharyngeal Airway Reduces The Incidence Of Hypoxia During Gastrointestinal Endoscopy Sedated With Propofol In Obese Patients: A Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05526339
- Acronym / sponsor ID
- LY2022-018-A
- Conditions
- Gastric Cancer, Gastric Ulcer, Intestinal Cancer, Intestinal Polyps
- Keywords
- High-flow nasal oxygenation, Gastrointestinal endoscopy, Hypoxia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Soochow University, Dushu Lake Hospital Affiliated to Soochow University
- Study start
- Sep 2022 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 2 Sep 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.
Obesity is associated with adverse airway events including desaturation during deep sedation. Previous studies have suggested that high-flow nasal oxygenation may be superior to regular (low-flow) nasal cannula for prevention of hypoxia during Sedated Gastrointestinal Endoscopy in non-obesity patients. The prerequisite of high-flow nasal oxygenation is keeping airway patency. Our pervious study demonstrated that nasopharyngeal airway has the similar efficacy of jaw-lift. In present study we aimed to determine whether high-flow nasal oxygenation combined with nasopharyngeal airway could reduce the incidence of hypoxia during Sedated Gastrointestinal Endoscopy in obese patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal oxygenation combined with nasopharyngeal airway | Experimental | Device: High-flow nasal oxygenation combined with nasopharyngeal airwayHigh-flow nasal oxygenation combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol. |
| Regular nasal cannula combined with nasopharyngeal airway | Active comparator | Device: Regular nasal cannula combined with nasopharyngeal airwayRegular nasal cannula combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients receiving selective combined upper intestinal and lower intestinal endoscopy procedure under deep sedation.
- Age ranging from 19 to 80, both male and female
- Obese patients，BMI ≥ 28kg/m^2
- ASA I~III
- Patients should clearly understand and voluntarily participate in the study, with signed informed consent.
Key exclusion criteria (13 listed)
- Patients with acute respiratory infection in the last 2 weeks
- Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery
- hypoxia, defined as oxygen saturation measured by pulse oximetry (SpO2) ≤ 95% before preoxygenation.
- Common advanced gastrointestinal endoscopy procedures meeting eligibility criteria included cholangiopancreatography, endoscopic ultrasound procedures, endoscopic mucosal resection and endoscopic retrograde cholangiopancreatography (ERCP) procedures.
- coagulation disorders or platelets < 100*10^9/L
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 oxygenation combined with nasopharyngeal airwayThe patients receive an oxygen flow of 30 L/min for preoxygenation with a high-flow oxygenation device before losing of conscious. At the time of the abolition of the eyelash reflex, the gas flow was increased to 60 L/min with an inspired oxygen fraction 100% and the nasopharyngeal airway was placed. | Device | High-flow nasal oxygenation combined with nasopharyngeal airway |
| Regular nasal cannula combined with nasopharyngeal airwayThe patients receive an oxygen flow of 6 L/min for preoxygenation with a regular nasal cannula until the end of procedure. At the time of abolition of the eyelash reflex, the nasopharyngeal airway was placed. | Device | Regular nasal cannula combined with nasopharyngeal airway |
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
3 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
The incidence of other adverse events
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 2 Sep 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.
Diansan Su principal investigator
RenJi Hospital
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 oxygenation combined with nasopharyngeal airway and Regular nasal cannula combined with nasopharyngeal airway in people with Gastric Cancer and Gastric Ulcer, 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 5 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: status not confirmed, as of the sponsor's last update on 2 Sep 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 Diansan Su (+8618616514088, 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 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 2 Sep 2022.