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Not yet recruitingNCT07489157Updated Mar 27, 2026

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

An interventional study of a microstream capnography nasal end-tidal carbon dioxide sampling tube in Hypoxemia, sponsored by Chinese PLA General Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
460
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
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Conditions studied

  • Hypoxemia

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Keywords

  • hypoxemia
  • End-Tidal Carbon Dioxide Monitoring
  • Gastrointestinal Endoscopy
  • Painless
03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 242 are open to participants now.

This study's planned enrollment of 460 is above the median of 45 across 854 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients undergoing gastroscopy and colonoscopy under intravenous anesthesia

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
460 participants (estimated)

Study arms

  • No intervention
    Group C

    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.

  • Experimental
    Group T

    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

  • 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.

06

What researchers measure

Primary outcomes

  1. incidence of hypoxemia

    Incidence of SpO₂ \< 95%(%)

    Time frame: During gastrointestinal endoscopy

  2. Duration of hypoxemia

    Duration of of SpO₂ \< 95%(seconds)

    Time frame: During gastrointestinal endoscopy

Secondary outcomes

  1. Incidence of movement

    Incidence of movement(%)

    Time frame: during gastrointestinal endoscopy

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Study locations

1 site
  • Chinese PLA General Hospital
    Beijing, 100853, China
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References and documents

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 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. PubMed 33905213 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07489157
Lead sponsor
Chinese PLA General Hospital
Responsible party
Peiqi Wang (Principal Investigator, Chinese PLA General Hospital) — Principal investigator
First posted
Mar 23, 2026
Start date
Mar 27, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Mar 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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