HypoxemiaNCT07489157
Real-Time End-Tidal Carbon Dioxide Monitoring for Early Warning of Hypoxemia in Painless Gastrointestinal Endoscopy
A study testing a microstream capnography nasal end-tidal carbon dioxide sampling tube in people with Hypoxemia, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Using Capnography for Safer Sedation in Painless Gastrointestinal Endoscopy Why is this study important? For procedures like painless gastroscopy and colonoscopy, patients receive sedation to ensure comfort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia
- What is being tested?
- a microstream capnography nasal end-tidal carbon dioxide sampling tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 gastroscopy and colonoscopy under intravenous anesthesia
Who cannot join
- patients unable to wear the sampling device;
- patients with a pulse oximetry reading (SpO2) of less than 95% when breathing ambient air
- central nervous system abnormalities
- patients who do not consent to participate in the study
- poor bowel preparation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese PLA General Hospital
Beijing, 100853
Peiqi Wang, PhD, 86+13141307586, qiqi218@sina.com
About this study
Official title: Application of Real-Time End-Tidal Carbon Dioxide Monitoring in Painless Gastrointestinal Endoscopy
Using Capnography for Safer Sedation in Painless Gastrointestinal Endoscopy
Why is this study important? For procedures like painless gastroscopy and colonoscopy, patients receive sedation to ensure comfort. However, traditional monitoring (like checking heart rate and blood oxygen levels) can only detect breathing problems after they have already caused a drop in oxygen. This delay can be risky, especially for elderly patients whose breathing function is naturally weaker. This study looks at a better way to monitor patients.
Read more
What is the new method? This study focuses on a technology called real-time end-tidal carbon dioxide (ETCO₂) monitoring, also known as capnography. It is a simple, non-invasive device that continuously measures the carbon dioxide a patient breathes out. This provides an early warning system for doctors, alerting them to breathing issues (like a pause in breathing or an airway blockage) much sooner than traditional monitors can.
What did the study find?
Based on extensive research and clinical experience both in China and internationally (including the US and Europe), integrating ETCO₂ monitoring into painless digestive endoscopy procedures leads to significant improvements in patient safety:
- Reduces Risks: It can decrease the occurrence of hypoxemia (dangerously low oxygen levels) by up to 31%.
- Early Detection: It detects breathing problems 17.6 times more often than relying on traditional observation alone, giving anesthesiologists crucial extra time (often seconds) to intervene before a patient's oxygen drops.
- Safer for Everyone: It is particularly effective in protecting high-risk groups, such as elderly patients and those with mild obesity.
- Better Outcomes: It helps reduce postoperative complications like nausea and vomiting, and can lead to faster recovery from anesthesia.
Value for Patients, Families, and Providers:
- For Patients \& Families: This technology means a safer, more comfortable procedure with a lower risk of breathing complications. It provides peace of mind knowing your breathing is being watched continuously and carefully.
- For Healthcare Providers: It offers a clear, real-time picture of a patient's breathing status. This supports quicker, more confident clinical decisions, reduces workload, and helps establish a standardized, quantifiable safety protocol for non-operating room anesthesia, aligning with the World Health Organization's goals for safer surgery.
- Conditions
- Hypoxemia
- Being tested
- a microstream capnography nasal end-tidal carbon dioxide sampling tube
- Keywords
- hypoxemia, End-Tidal Carbon Dioxide Monitoring, Gastrointestinal Endoscopy, Painless
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a microstream capnography nasal end-tidal carbon dioxide sampling tubeDevice
In addition to routine monitoring (ECG, NIBP, and SpO2), a microstream capnography nasal end-tidal carbon dioxide sampling tube is used for end-tidal carbon dioxide capnography monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Group C | No intervention | The patient was positioned in the left lateral decubitus position, with oxygen being administered via nasal cannula at a rate of 2 liters per minute(2L/min). End-tidal carbon dioxide (ETCO2) was collected using a microstream capnography nasal sampling tube. Both groups of patients wore nasal cannulas for end-tidal carbon dioxide monitoring. the control group (C group) had the capnograph monitor screen obscured and the machine sound muted. |
| Group T | Experimental | The patient was positioned in the left lateral decubitus position, with oxygen being administered via nasal cannula at a rate of 2 liters per minute(2L/min). End-tidal carbon dioxide (ETCO2) was collected using a microstream capnography nasal sampling tube. Both groups of patients wore nasal cannulas for end-tidal carbon dioxide monitoring. The observation group (T group) viewed the capnograph monitor (Capnostream 20P Patient Monitor, Medtronic Inc., Minnesota, Minneapolis, USA), screen and heard the initiation sound of the machine. Receives: Device: a microstream capnography nasal end-tidal carbon dioxide sampling tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hypoxemia
Incidence of SpO₂ < 95%(%)
Measured: During gastrointestinal endoscopy
Duration of hypoxemia
Duration of of SpO₂ < 95%(seconds)
Measured: During gastrointestinal endoscopy
Secondary outcomes (1)
Incidence of movement
Incidence of movement(%)
Measured: during gastrointestinal endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start27 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiqi Wang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489157
- Sponsor's protocol ID
- PLAGH-L04
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.
PubMed 32925318Bisschops R, Saunders R, Dooms C, Hoffman I, van der Merwe S, Weissbrod R, Torres RT, Van Assche G, Demedts I. Implementing capnography to help improve patient safety during procedural sedation: quality improvement in a high-volume gastroenterology department. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e522-e528. doi: 10.1097/MEG.0000000000002144.
PubMed 33905213
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Real-Time End-Tidal Carbon Dioxide Monitoring in Painless Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT07489157
- Acronym / sponsor ID
- PLAGH-L04
- Conditions
- Hypoxemia
- Keywords
- hypoxemia, End-Tidal Carbon Dioxide Monitoring, Gastrointestinal Endoscopy, Painless
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 27 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 23 Mar 2026 (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.
Using Capnography for Safer Sedation in Painless Gastrointestinal Endoscopy
Why is this study important? For procedures like painless gastroscopy and colonoscopy, patients receive sedation to ensure comfort. However, traditional monitoring (like checking heart rate and blood oxygen levels) can only detect breathing problems after they have already caused a drop in oxygen. This delay can be risky, especially for elderly patients whose breathing function is naturally weaker. This study looks at a better way to monitor patients.
What is the new method? This study focuses on a technology called real-time end-tidal carbon dioxide (ETCO₂) monitoring, also known as capnography. It is a simple, non-invasive device that continuously measures the carbon dioxide a patient breathes out. This provides an early warning system for doctors, alerting them to breathing issues (like a pause in breathing or an airway blockage) much sooner than traditional monitors can.
What did the study find?
Based on extensive research and clinical experience both in China and internationally (including the US and Europe), integrating ETCO₂ monitoring into painless digestive endoscopy procedures leads to significant improvements in patient safety:
- Reduces Risks: It can decrease the occurrence of hypoxemia (dangerously low oxygen levels) by up to 31%.
- Early Detection: It detects breathing problems 17.6 times more often than relying on traditional observation alone, giving anesthesiologists crucial extra time (often seconds) to intervene before a patient's oxygen drops.
- Safer for Everyone: It is particularly effective in protecting high-risk groups, such as elderly patients and those with mild obesity.
- Better Outcomes: It helps reduce postoperative complications like nausea and vomiting, and can lead to faster recovery from anesthesia.
Value for Patients, Families, and Providers:
- For Patients \& Families: This technology means a safer, more comfortable procedure with a lower risk of breathing complications. It provides peace of mind knowing your breathing is being watched continuously and carefully.
- For Healthcare Providers: It offers a clear, real-time picture of a patient's breathing status. This supports quicker, more confident clinical decisions, reduces workload, and helps establish a standardized, quantifiable safety protocol for non-operating room anesthesia, aligning with the World Health Organization's goals for safer surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | No intervention | –The patient was positioned in the left lateral decubitus position, with oxygen being administered via nasal cannula at a rate of 2 liters per minute(2L/min). End-tidal carbon dioxide (ETCO2) was collected using a microstream capnography nasal sampling tube. Both groups of patients wore nasal cannulas for end-tidal carbon dioxide monitoring. the control group (C group) had the capnograph monitor screen obscured and the machine sound muted. |
| Group T | Experimental | Device: a microstream capnography nasal end-tidal carbon dioxide sampling tubeThe patient was positioned in the left lateral decubitus position, with oxygen being administered via nasal cannula at a rate of 2 liters per minute(2L/min). End-tidal carbon dioxide (ETCO2) was collected using a microstream capnography nasal sampling tube. Both groups of patients wore nasal cannulas for end-tidal carbon dioxide monitoring. The observation group (T group) viewed the capnograph monitor (Capnostream 20P Patient Monitor, Medtronic Inc., Minnesota, Minneapolis, USA), screen and heard the initiation sound of the machine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing gastroscopy and colonoscopy under intravenous anesthesia
Key exclusion criteria (5 listed)
- patients unable to wear the sampling device;
- patients with a pulse oximetry reading (SpO2) of less than 95% when breathing ambient air
- central nervous system abnormalities
- patients who do not consent to participate in the study
- poor bowel preparation.
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 |
|---|---|---|
| a microstream capnography nasal end-tidal carbon dioxide sampling tubeIn addition to routine monitoring (ECG, NIBP, and SpO2), a microstream capnography nasal end-tidal carbon dioxide sampling tube is used for end-tidal carbon dioxide capnography monitoring. | Device | Group T |
Primary outcome
incidence of hypoxemia
Time frame: During gastrointestinal endoscopy
Incidence of SpO₂ < 95%(%)
Duration of hypoxemia
Time frame: During gastrointestinal endoscopy
Duration of of SpO₂ < 95%(seconds)
1 secondary outcome
Incidence of movement
Time frame: during gastrointestinal endoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Results publication: PubMed 32925318Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.
- Results publication: PubMed 33905213Bisschops R, Saunders R, Dooms C, Hoffman I, van der Merwe S, Weissbrod R, Torres RT, Van Assche G, Demedts I. Implementing capnography to help improve patient safety during procedural sedation: quality improvement in a high-volume gastroenterology department. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e522-e528. doi: 10.1097/MEG.0000000000002144.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a microstream capnography nasal end-tidal carbon dioxide sampling tube in people with Hypoxemia, run by Chinese PLA General Hospital 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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 27 Mar 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?
This study is still under way. Results are not available in the source record yet.
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: During gastrointestinal endoscopy). The study lists 2 primary outcomes in all. 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 NCT07489157, which also lists 2 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 Mar 2026.