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NCT Number: NCT07489157

Real-Time End-Tidal Carbon Dioxide Monitoring for Early Warning of Hypoxemia 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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA General Hospital

Beijing, 100853, China

Location contact

Peiqi Wang, PhD

CONTACT

[email protected]

86+13141307586

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a microstream capnography nasal end-tidal carbon dioxide sampling tube

Device

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.

Primary outcomes

  1. incidence of hypoxemia

    Time frame: During gastrointestinal endoscopy

    Incidence of SpO₂ < 95%(%)

  2. Duration of hypoxemia

    Time frame: During gastrointestinal endoscopy

    Duration of of SpO₂ < 95%(seconds)

Secondary outcomes

  1. Incidence of movement

    Time frame: during gastrointestinal endoscopy

    Incidence of movement(%)

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 23, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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