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Real-Time End-Tidal Carbon Dioxide Monitoring for Early Warning of Hypoxemia in Painless Gastrointestinal Endoscopy

Application of Real-Time End-Tidal Carbon Dioxide Monitoring in Painless Gastrointestinal Endoscopy

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07489157
Enrollment
460
Registered
2026-03-23
Start date
2026-03-27
Completion date
2027-01-31
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemia

Keywords

hypoxemia, End-Tidal Carbon Dioxide Monitoring, Gastrointestinal Endoscopy, Painless

Brief 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. 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.

Interventions

DEVICEa microstream capnography nasal end-tidal carbon dioxide sampling tube

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.

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients undergoing gastroscopy and colonoscopy under intravenous anesthesia

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
incidence of hypoxemiaDuring gastrointestinal endoscopyIncidence of SpO₂ \< 95%(%)
Duration of hypoxemiaDuring gastrointestinal endoscopyDuration of of SpO₂ \< 95%(seconds)

Secondary

MeasureTime frameDescription
Incidence of movementduring gastrointestinal endoscopyIncidence of movement(%)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026