HypoxemiaNCT06085859
Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment
A study testing Routine nasal catheter group and Mask group in people with Hypoxemia, run by Sichuan Provincial People's Hospital at 5 sites in China.
Trial summary
To investigate the efficacy and safety of new-type mask compared with nasal tube oxygen delivery in patients undergoing sedation of upper gastrointestinal endoscopy Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Routine nasal catheter group and Mask group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,208 participants
- Where
- 5 sitesChina
- Study dates
- 18 Oct 2023to 8 Dec 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Upcoming upper gastrointestinal sedation procedure;
- Classification under the American Association of Anesthesiologists (ASA) status I-III;
- Baseline oxygen saturation (SpO2) ≥95% in ambient air conditions.
Who cannot join
- Individuals with previously documented difficulties in mask ventilation (DMV);
- Patients predisposed to aspiration risks or episodes of vomiting;
- Facial or jaw injuries or congenital abnormalities that render conventional face mask application infeasible;
- An inability or unwillingness to utilize the novel disposable anesthesia face mask.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Mengchang Yang, Doctor, +8618140049936, ymc681@126.com
- Recruiting
First People's Hospital of Liangshan Yi Autonomous Prefecture
Liangshan, Sichuan
Xiang Shen, 18981561217, 455517537@qq.com
- Recruiting
Chengdu Second People's Hospital
Sichuan
Shaoxing Liu, +8618030611589, liu110022@126.com
- Recruiting
Second People's Hospital of Yibin
Yibin, Sichuan
Jinghua Ren, 15351350950, 272171373@qq.com
- Recruiting
Ziyang People's Hospital
Ziyang, Sichuan
Xinquan Liu, 15892348079, 1355302984@qq.com
About this study
Official title: Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment: Multi-center, Prospective, Randomized Control, Open Clinical Research
To investigate the efficacy and safety of new-type mask compared with nasal tube oxygen delivery in patients undergoing sedation of upper gastrointestinal endoscopy
Read the detailed description
This study aims to utilize a large sample, multicenter, prospective clinical trial using a new mask oxygen supply technology. If the study confirms that the new mask can improve the airway safety and effectiveness in patient examinations, while improving examination efficiency and reducing failure rates, it will provide safety assurance for the early diagnosis and treatment of upper gastrointestinal diseases in high-risk populations.
- Conditions
- Hypoxemia
- Being tested
- Routine nasal catheter group, Mask group
- Keywords
- hypoxemia, sedation, gastrointestinal sedation procedure, non-invasive ventilation, endoscopy mask
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine nasal catheter groupDevice
The anaesthesia provider supplied oxygen via a nasal cannula at an oxygen flow rate of 8 Litres/minute supplied from an oxygen flowmeter as described in the guide
Mask groupDevice
The study team applied the mask with a head strap to ensure a proper seal,simultaneously ensuring the same oxygen flow rate as the control group
| Study group | Role | What they receive |
|---|---|---|
| Mask oxygen supply group | Experimental | The anaesthesia provider supplied oxygen via a nasal cannula at an oxygen flow rate of 8 Litres/minute supplied from an oxygen flowmeter Receives: Device: Mask group |
| Nasal oxygen supply group | Experimental | The study team applied the mask with a head strap to ensure a proper seal,simultaneously ensuring the same oxygen flow rate as the control group Receives: Device: Routine nasal catheter group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxemia
Incidences of oxygen saturation falling below 92%
Measured: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Secondary outcomes (11)
Incidence of compromised ventilation mandating primary manual intervention
For the nasal catheter cohort, this entailed jaw elevation and deploying a standard mask to augment the oxygen concentration inhaled. Concurrently, for the mask cohort, primary intervention involved mandible lifting and secure fastening of the mask sleeve for inflation (while ensuring the operational aperture remains sealed).
Measured: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Incidence necessitating sophisticated manual ventilatory support during pain-free gastroscopy
If SpO2 levels further descended to ≤70% or persistently hovered below 85% for a duration exceeding 60 seconds, it mandated an immediate cessation of the ongoing procedure. The endoscope would be retracted, followed by the insertion of a standard oropharyngeal mask for assisted ventilation. In dire circumstances, the anesthesiologist might opt for advanced airway interventions, such as laryngeal mask application or endotracheal intubation.
Measured: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Juxtaposition of hypoxemia onset time in both ventilation techniques
The time span from the start of drug administration by the researcher to the first occurrence of blood oxygen saturation below 92%.
Measured: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
the temporal span from initial decline to recovery to 92% saturation in both ventilation techniques
The time span from oxygen saturation below 92% to recovery to 92% after manual ventilatory support. If multiple episodes of hypoxia occur, all times will be added up
Measured: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
the lowest oxygen saturation in both ventilation techniques
the lowest oxygen saturation from the start of medication administration to the participants's Aldrete score of 9.
Measured: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Evaluation of procedural prolongation due to ventilation issues
The extension time for examination is defined as the total time from stopping the operation and exiting the endoscope until the endoscope re-enters the digestive tract, to the same anatomical position before stopping the operation, If multiple episodes of withdrawal of endoscopy occur, all times will be added up
Measured: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Apnea prevalence in both groups
The study here we define apnea as 10 second without obvious respiratory movements of mesothorax and abdomen or snoring with paradoxical breathing
Measured: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Satisfaction scores1 from patients, endoscopists, and anesthesiologists
The scores of satisfaction 1：Are you satisfied with this endoscopic diagnosis and treatment,a score of 0 represents very dissatisfied, while a score of 10 represents very satisfied.
Measured: Immediately after the procedure.
Satisfaction scores2 from patients, endoscopists, and anesthesiologists
The scores of satisfaction2：If there is a chance, are you willing to use this non-invasive oxygen device again,a score of 0 indicates a strong unwillingness, while a score of 10 indicates a strong willingness.
Measured: Immediately after the procedure.
The incidence of upper respiratory tract discomfort manifestations such as oral, nasal, an pharyngeal dryness and hemorrhage in two groups of participants.
Measured: Immediately after the procedure.
Inaugural insertion success rates in two groups of participants
If the endoscopic operation fails to pass the pharynx after three attempts, recorded as the first insertion failure.
Measured: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start18 Oct 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion8 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomly assign participants to the standard nasal catheter oxygenation group and the endoscopy mask oxygen inhalation group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Sanhong Medical Device Technology Co., Ltd
- Responsible party
- Principal investigator, Mengchang Yang, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085859
- Sponsor's protocol ID
- endoscope mask-1
- Status last verified
- Nov 2023
- First submitted
- 25 Sep 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After December 2024, the original data can be obtained through the author's email address.
Publications
Behrens A, Kreuzmayr A, Manner H, Koop H, Lorenz A, Schaefer C, Plauth M, Jetschmann JU, von Tirpitz C, Ewald M, Sackmann M, Renner W, Kruger M, Schwab D, Hoffmann W, Engelke O, Pech O, Kullmann F, Pampuch S, Lenfers B, Weickert U, Schilling D, Boehm S, Beckebaum S, Cicinnati V, Erckenbrecht JF, Dumoulin FL, Benz C, Rabenstein T, Haltern G, Balsliemke M, de Mas C, Kleber G, Pehl C, Vogt C, Kiesslich R, Fischbach W, Koop I, Kuehne J, Breidert M, Sass NL, May A, Friedrich C, Veitt R, Porschen R, Ellrichmann M, Arlt A, Schmitt W, Dollhopf M, Schmidbaur W, Dignass A, Schmitz V, Labenz J, Kaiser G, Krannich A, Barteska N, Ell C. Acute sedation-associated complications in GI endoscopy (ProSed 2 Study): results from the prospective multicentre electronic registry of sedation-associated complications. Gut. 2019 Mar;68(3):445-452. doi: 10.1136/gutjnl-2015-311037. Epub 2018 Jan 3.
PubMed 29298872Nay MA, Fromont L, Eugene A, Marcueyz JL, Mfam WS, Baert O, Remerand F, Ravry C, Auvet A, Boulain T. High-flow nasal oxygenation or standard oxygenation for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial (ODEPHI trial). Br J Anaesth. 2021 Jul;127(1):133-142. doi: 10.1016/j.bja.2021.03.020. Epub 2021 Apr 28.
PubMed 33933271Goudra B, Nuzat A, Singh PM, Borle A, Carlin A, Gouda G. Association between Type of Sedation and the Adverse Events Associated with Gastrointestinal Endoscopy: An Analysis of 5 Years' Data from a Tertiary Center in the USA. Clin Endosc. 2017 Mar;50(2):161-169. doi: 10.5946/ce.2016.019. Epub 2016 Apr 29.
PubMed 27126387Qin Y, Li LZ, Zhang XQ, Wei Y, Wang YL, Wei HF, Wang XR, Yu WF, Su DS. Supraglottic jet oxygenation and ventilation enhances oxygenation during upper gastrointestinal endoscopy in patients sedated with propofol: a randomized multicentre clinical trial. Br J Anaesth. 2017 Jul 1;119(1):158-166. doi: 10.1093/bja/aex091.
PubMed 28974061Bell GD, Bown S, Morden A, Coady T, Logan RF. Prevention of hypoxaemia during upper-gastrointestinal endoscopy by means of oxygen via nasal cannulae. Lancet. 1987 May 2;1(8540):1022-4. doi: 10.1016/s0140-6736(87)92282-3.
PubMed 2883355Terblanche NCS, Middleton C, Choi-Lundberg DL, Skinner M. Efficacy of a new dual channel laryngeal mask airway, the LMA(R)Gastro Airway, for upper gastrointestinal endoscopy: a prospective observational study. Br J Anaesth. 2018 Feb;120(2):353-360. doi: 10.1016/j.bja.2017.11.075. Epub 2017 Dec 1.
PubMed 29406183King AB, Alvis BD, Hester D, Taylor S, Higgins M. Randomized trial of a novel double lumen nasopharyngeal catheter versus traditional nasal cannula during total intravenous anesthesia for gastrointestinal procedures. J Clin Anesth. 2017 May;38:52-56. doi: 10.1016/j.jclinane.2017.01.025. Epub 2017 Jan 22.
PubMed 28372678Hung KC, Chang YJ, Chen IW, Soong TC, Ho CN, Hsing CH, Chu CC, Chen JY, Sun CK. Efficacy of high flow nasal oxygenation against hypoxemia in sedated patients receiving gastrointestinal endoscopic procedures: A systematic review and meta-analysis. J Clin Anesth. 2022 May;77:110651. doi: 10.1016/j.jclinane.2022.110651. Epub 2022 Jan 12.
PubMed 35030538
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment: Multi-center, Prospective, Randomized Control, Open Clinical Research
- ClinicalTrials.gov ID
- NCT06085859
- Acronym / sponsor ID
- endoscope mask-1
- Conditions
- Hypoxemia
- Keywords
- hypoxemia, sedation, gastrointestinal sedation procedure, non-invasive ventilation, endoscopy mask
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,208 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Anhui Sanhong Medical Device Technology Co., Ltd
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 8 Dec 2023 (estimated)
- First posted
- 17 Oct 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.
To investigate the efficacy and safety of new-type mask compared with nasal tube oxygen delivery in patients undergoing sedation of upper gastrointestinal endoscopy
Detailed description
This study aims to utilize a large sample, multicenter, prospective clinical trial using a new mask oxygen supply technology. If the study confirms that the new mask can improve the airway safety and effectiveness in patient examinations, while improving examination efficiency and reducing failure rates, it will provide safety assurance for the early diagnosis and treatment of upper gastrointestinal diseases in high-risk populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomly assign participants to the standard nasal catheter oxygenation group and the endoscopy mask oxygen inhalation group
| Arm | Type | Receives |
|---|---|---|
| Mask oxygen supply group | Experimental | Device: Mask groupThe anaesthesia provider supplied oxygen via a nasal cannula at an oxygen flow rate of 8 Litres/minute supplied from an oxygen flowmeter |
| Nasal oxygen supply group | Experimental | Device: Routine nasal catheter groupThe study team applied the mask with a head strap to ensure a proper seal,simultaneously ensuring the same oxygen flow rate as the control group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Upcoming upper gastrointestinal sedation procedure;
- Classification under the American Association of Anesthesiologists (ASA) status I-III;
- Baseline oxygen saturation (SpO2) ≥95% in ambient air conditions.
Key exclusion criteria (4 listed)
- Individuals with previously documented difficulties in mask ventilation (DMV);
- Patients predisposed to aspiration risks or episodes of vomiting;
- Facial or jaw injuries or congenital abnormalities that render conventional face mask application infeasible;
- An inability or unwillingness to utilize the novel disposable anesthesia face mask.
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 |
|---|---|---|
| Routine nasal catheter groupThe anaesthesia provider supplied oxygen via a nasal cannula at an oxygen flow rate of 8 Litres/minute supplied from an oxygen flowmeter as described in the guide | Device | Nasal oxygen supply group |
| Mask groupThe study team applied the mask with a head strap to ensure a proper seal,simultaneously ensuring the same oxygen flow rate as the control group | Device | Mask oxygen supply group |
Primary outcome
Incidence of hypoxemia
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Incidences of oxygen saturation falling below 92%
11 secondary outcomes
Incidence of compromised ventilation mandating primary manual intervention
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Incidence necessitating sophisticated manual ventilatory support during pain-free gastroscopy
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Juxtaposition of hypoxemia onset time in both ventilation techniques
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
the temporal span from initial decline to recovery to 92% saturation in both ventilation techniques
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
the lowest oxygen saturation in both ventilation techniques
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Evaluation of procedural prolongation due to ventilation issues
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Apnea prevalence in both groups
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Satisfaction scores1 from patients, endoscopists, and anesthesiologists
Time frame: Immediately after the procedure.
Satisfaction scores2 from patients, endoscopists, and anesthesiologists
Time frame: Immediately after the procedure.
The incidence of upper respiratory tract discomfort manifestations such as oral, nasal, an pharyngeal dryness and hemorrhage in two groups of participants.
Time frame: Immediately after the procedure.
Inaugural insertion success rates in two groups of participants
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 29298872Behrens A, Kreuzmayr A, Manner H, Koop H, Lorenz A, Schaefer C, Plauth M, Jetschmann JU, von Tirpitz C, Ewald M, Sackmann M, Renner W, Kruger M, Schwab D, Hoffmann W, Engelke O, Pech O, Kullmann F, Pampuch S, Lenfers B, Weickert U, Schilling D, Boehm S, Beckebaum S, Cicinnati V, Erckenbrecht JF, Dumoulin FL, Benz C, Rabenstein T, Haltern G, Balsliemke M, de Mas C, Kleber G, Pehl C, Vogt C, Kiesslich R, Fischbach W, Koop I, Kuehne J, Breidert M, Sass NL, May A, Friedrich C, Veitt R, Porschen R, Ellrichmann M, Arlt A, Schmitt W, Dollhopf M, Schmidbaur W, Dignass A, Schmitz V, Labenz J, Kaiser G, Krannich A, Barteska N, Ell C. Acute sedation-associated complications in GI endoscopy (ProSed 2 Study): results from the prospective multicentre electronic registry of sedation-associated complications. Gut. 2019 Mar;68(3):445-452. doi: 10.1136/gutjnl-2015-311037. Epub 2018 Jan 3.
- Background: PubMed 33933271Nay MA, Fromont L, Eugene A, Marcueyz JL, Mfam WS, Baert O, Remerand F, Ravry C, Auvet A, Boulain T. High-flow nasal oxygenation or standard oxygenation for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial (ODEPHI trial). Br J Anaesth. 2021 Jul;127(1):133-142. doi: 10.1016/j.bja.2021.03.020. Epub 2021 Apr 28.
- Background: PubMed 27126387Goudra B, Nuzat A, Singh PM, Borle A, Carlin A, Gouda G. Association between Type of Sedation and the Adverse Events Associated with Gastrointestinal Endoscopy: An Analysis of 5 Years' Data from a Tertiary Center in the USA. Clin Endosc. 2017 Mar;50(2):161-169. doi: 10.5946/ce.2016.019. Epub 2016 Apr 29.
- Background: PubMed 28974061Qin Y, Li LZ, Zhang XQ, Wei Y, Wang YL, Wei HF, Wang XR, Yu WF, Su DS. Supraglottic jet oxygenation and ventilation enhances oxygenation during upper gastrointestinal endoscopy in patients sedated with propofol: a randomized multicentre clinical trial. Br J Anaesth. 2017 Jul 1;119(1):158-166. doi: 10.1093/bja/aex091.
- Background: PubMed 2883355Bell GD, Bown S, Morden A, Coady T, Logan RF. Prevention of hypoxaemia during upper-gastrointestinal endoscopy by means of oxygen via nasal cannulae. Lancet. 1987 May 2;1(8540):1022-4. doi: 10.1016/s0140-6736(87)92282-3.
- Background: PubMed 29406183Terblanche NCS, Middleton C, Choi-Lundberg DL, Skinner M. Efficacy of a new dual channel laryngeal mask airway, the LMA(R)Gastro Airway, for upper gastrointestinal endoscopy: a prospective observational study. Br J Anaesth. 2018 Feb;120(2):353-360. doi: 10.1016/j.bja.2017.11.075. Epub 2017 Dec 1.
- Background: PubMed 28372678King AB, Alvis BD, Hester D, Taylor S, Higgins M. Randomized trial of a novel double lumen nasopharyngeal catheter versus traditional nasal cannula during total intravenous anesthesia for gastrointestinal procedures. J Clin Anesth. 2017 May;38:52-56. doi: 10.1016/j.jclinane.2017.01.025. Epub 2017 Jan 22.
- Background: PubMed 35030538Hung KC, Chang YJ, Chen IW, Soong TC, Ho CN, Hsing CH, Chu CC, Chen JY, Sun CK. Efficacy of high flow nasal oxygenation against hypoxemia in sedated patients receiving gastrointestinal endoscopic procedures: A systematic review and meta-analysis. J Clin Anesth. 2022 May;77:110651. doi: 10.1016/j.jclinane.2022.110651. Epub 2022 Jan 12.
- Individual participant dataSharing planned: Yes. After December 2024, the original data can be obtained through the author's email address.
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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.
First People's Hospital of Liangshan Yi Autonomous Prefecture
Liangshan, China
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine nasal catheter group and Mask group in people with Hypoxemia, run by Sichuan Provincial People's Hospital at 5 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 4 inclusion and 4 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxemia (time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the 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 NCT06085859, which also lists 8 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 18 Nov 2023.