HypoxemiaNCT06139081
Oxygen Delivery Methods of Nasal Catheter on the Incidence of Hypoxemia in Patients With Painless Gastroscopy
A study testing Oxygen delivery mode in people with Hypoxemia, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
In this study, patients undergoing painless gastroscopy were selected to change the nasal catheter oxygen delivery mode to oral oxygen delivery after endoscope implantation, in order to explore the effect of this oxygen delivery mode on the incidence of hypoxemia during general anesthesia gastroscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Oxygen delivery mode
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2023to 14 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who receiving gastroscopy under general anesthesia, accompanied with one of the following risk factors of hypoxia:
- Patients combined with heart or respiratory diseases
- Age older than 60
- ASA grading II-III
- BMI≥30kg/m²,
- Snoring or having sleep apnea syndrome
- Patients with a STOP-Bang score ≥ 3 (the risk of OSAS is high) are considered to be highly risk of hypoxia.
Who cannot join
- Severe cardiovascular, pulmonary, liver, or kidney disease
- Patients with infections or tumors of airway
- History of difficult intubation under general anesthesia
- Severe sleep apnea syndrome [hypopnea/apnea hypopnea index (AHI)>40]
- Patients allergic to propofol, eggs, soy or egg whites
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Oxygen Delivery Methods of Nasal Catheter on the Incidence of Hypoxemia in Patients With High Risk of Hypoxia During Painless Gastroscopy
In this study, patients undergoing painless gastroscopy were selected to change the nasal catheter oxygen delivery mode to oral oxygen delivery after endoscope implantation, in order to explore the effect of this oxygen delivery mode on the incidence of hypoxemia during general anesthesia gastroscopy.
Read the detailed description
This study was a randomized controlled study in which patients undergoing elective painless gastroscopy were selected and grouped by random number table. The control group used conventional nasal cannula oxygen method: nasal cannula was used before, during and after gastroscopy was implanted and after withdrawing from the gastroscopy. Test group: Before the gastroscope enters the oral cavity, oxygen is administered through a nasal catheter via the nose. After the gastroscope enters the oral cavity, oxygen is administered through the nasal catheter via the mouth. After the gastroscope is withdrawn, oxygen is administered through the nasal catheter via the nose. The incidence of intraoperative hypoxemia was observed.
- Conditions
- Hypoxemia
- Being tested
- Oxygen delivery mode
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen delivery modeOther
After the implantation of the mirror, nasal catheter was used to give oxygen through the mouth
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Transnasal oxygen was administered by nasal catheter before gastroscopy, transoral oxygen was administered by nasal catheter during gastroscopy, and transnasal oxygen was administered by nasal catheter after withdrawal of gastroscope. Receives: Other: Oxygen delivery mode |
| Group B | No intervention | Nasal catheter was used to give oxygen before, during and after withdrawal of gastroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxemia
SpO2<92%
Measured: Five minutes after finishing gastroscopy examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start22 Dec 2023
- Primary completion13 Dec 2024
- Study completion14 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 648 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gu Jianping, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139081
- Sponsor's protocol ID
- KY20230915-10
- Status last verified
- Jul 2026
- First submitted
- 26 Oct 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tas Z, Hosten T, Kus A, Cesur S, Turkyilmaz N, Arikan A, Solak ZM. Comparison of tidal volume and deep breath preoxygenation techniquesundergoing coronary artery bypass graft surgery: effects of hemodynamicresponse and arterial oxygenation. Turk J Med Sci. 2017 Nov 13;47(5):1576-1582. doi: 10.3906/sag-1606-132.
PubMed 29151335Chen DX, Yang H, Wu XP, Niu W, Ding L, Zeng HL, Li Q. Comparison of a Nasal Mask and Traditional Nasal Cannula During Intravenous Anesthesia for Gastroscopy Procedures: A Randomized Controlled Trial. Anesth Analg. 2022 Mar 1;134(3):615-623. doi: 10.1213/ANE.0000000000005828.
PubMed 34878412Gavrilovska-Brzanov A, Shosholcheva M, Kartalov A, Jovanovski-Srceva M, Brzanov N, Kuzamanovska B. Medium-Flow Oxygenation Through Facial Mask and Nasal Cannula in a Limited Resource Setting. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2022 Jul 13;43(2):101-109. doi: 10.2478/prilozi-2022-0023.
PubMed 35843919
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Oxygen Delivery Methods of Nasal Catheter on the Incidence of Hypoxemia in Patients With High Risk of Hypoxia During Painless Gastroscopy
- ClinicalTrials.gov ID
- NCT06139081
- Acronym / sponsor ID
- KY20230915-10
- Conditions
- Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 648 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 14 Dec 2024 (actual)
- First posted
- 18 Nov 2023 (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.
In this study, patients undergoing painless gastroscopy were selected to change the nasal catheter oxygen delivery mode to oral oxygen delivery after endoscope implantation, in order to explore the effect of this oxygen delivery mode on the incidence of hypoxemia during general anesthesia gastroscopy.
Detailed description
This study was a randomized controlled study in which patients undergoing elective painless gastroscopy were selected and grouped by random number table. The control group used conventional nasal cannula oxygen method: nasal cannula was used before, during and after gastroscopy was implanted and after withdrawing from the gastroscopy. Test group: Before the gastroscope enters the oral cavity, oxygen is administered through a nasal catheter via the nose. After the gastroscope enters the oral cavity, oxygen is administered through the nasal catheter via the mouth. After the gastroscope is withdrawn, oxygen is administered through the nasal catheter via the nose. The incidence of intraoperative hypoxemia was observed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Oxygen delivery modeTransnasal oxygen was administered by nasal catheter before gastroscopy, transoral oxygen was administered by nasal catheter during gastroscopy, and transnasal oxygen was administered by nasal catheter after withdrawal of gastroscope. |
| Group B | No intervention | –Nasal catheter was used to give oxygen before, during and after withdrawal of gastroscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who receiving gastroscopy under general anesthesia, accompanied with one of the following risk factors of hypoxia:
- Patients combined with heart or respiratory diseases
- Age older than 60
- ASA grading II-III
- BMI≥30kg/m²,
Key exclusion criteria (6 listed)
- Severe cardiovascular, pulmonary, liver, or kidney disease
- Patients with infections or tumors of airway
- History of difficult intubation under general anesthesia
- Severe sleep apnea syndrome [hypopnea/apnea hypopnea index (AHI)>40]
- Patients allergic to propofol, eggs, soy or egg whites
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 |
|---|---|---|
| Oxygen delivery modeAfter the implantation of the mirror, nasal catheter was used to give oxygen through the mouth | Other | Group A |
Primary outcome
Incidence of hypoxemia
Time frame: Five minutes after finishing gastroscopy examination
SpO2<92%
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 27 Jul 2026.
- Results publication: PubMed 29151335Tas Z, Hosten T, Kus A, Cesur S, Turkyilmaz N, Arikan A, Solak ZM. Comparison of tidal volume and deep breath preoxygenation techniquesundergoing coronary artery bypass graft surgery: effects of hemodynamicresponse and arterial oxygenation. Turk J Med Sci. 2017 Nov 13;47(5):1576-1582. doi: 10.3906/sag-1606-132.
- Results publication: PubMed 34878412Chen DX, Yang H, Wu XP, Niu W, Ding L, Zeng HL, Li Q. Comparison of a Nasal Mask and Traditional Nasal Cannula During Intravenous Anesthesia for Gastroscopy Procedures: A Randomized Controlled Trial. Anesth Analg. 2022 Mar 1;134(3):615-623. doi: 10.1213/ANE.0000000000005828.
- Results publication: PubMed 35843919Gavrilovska-Brzanov A, Shosholcheva M, Kartalov A, Jovanovski-Srceva M, Brzanov N, Kuzamanovska B. Medium-Flow Oxygenation Through Facial Mask and Nasal Cannula in a Limited Resource Setting. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2022 Jul 13;43(2):101-109. doi: 10.2478/prilozi-2022-0023.
- 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.
Gu Jianping study chair
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen delivery mode in people with Hypoxemia, run by Nanjing First Hospital, Nanjing Medical University 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 7 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: finished, as of the sponsor's last update on 27 Jul 2026. 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?
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 hypoxemia (time frame: Five minutes after finishing gastroscopy examination). 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 NCT06139081, which also lists 3 linked publications.
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 27 Jul 2026.