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

NCT07489157 | Not Yet Recruiting

• 1 other identifier: PLAGH-L04
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• incidence of hypoxemia

  Incidence of SpO₂ \< 95%(%)

  During gastrointestinal endoscopy

• Duration of hypoxemia

  Duration of of SpO₂ \< 95%(seconds)

  During gastrointestinal endoscopy

Secondary Outcomes (1)

• Incidence of movement

  during gastrointestinal endoscopy

Study Arms (2)

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.

Device: a microstream capnography nasal end-tidal carbon dioxide sampling tube

Interventions

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.

Group T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing gastroscopy and colonoscopy under intravenous anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

Location

Related Publications (2)

• 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.

  PMID: 32925318 RESULT

• 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 RESULT

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 23, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CN (1)