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

Official title

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

Overview

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

• Device a 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.

Primary outcome measures

• incidence of hypoxemia [Time frame: During gastrointestinal endoscopy]
• Duration of hypoxemia [Time frame: During gastrointestinal endoscopy]

Secondary outcome measures (1)

• Incidence of movement [Time frame: during gastrointestinal endoscopy]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

China · 1 center

• Chinese PLA General Hospital — Beijing

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) Gro PMID 32925318
• Bisschops 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. PMID 33905213

Identifiers

NCT: NCT07489157 · PLAGH-L04

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗