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

ConditionHypoxemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese PLA General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients undergoing gastroscopy and colonoscopy under intravenous anesthesia

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

460 Participants
are divided into 2 treatment groups
Group A: Group CNo intervention 0 interventions
Group B: Group TExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: