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OpenTrials
Completed

NCT Number: NCT06938919

Electronic Respiratory Sound Monitoring System in Gastrointestinal Endoscopic Sedation

This study aims to evaluate the application of an electronic respiratory sound monitoring system during sedation for gastrointestinal endoscopy and to determine its effectiveness in improving sedation quality. Gastrointestinal endoscopy is a common medical procedure, but respiratory complications caused by sedation, such as hypoventilation and airway obstruction, are significant safety concerns. Traditional respiratory monitoring methods, such as end-tidal CO2 monitoring, are often unreliable due to difficulties in gas sampling during the procedure. In contrast, an electronic respiratory sound monitoring system can accurately capture tracheal breathing sounds and provide important parameters such as respiratory rate and airway obstruction ratio, helping clinicians avoid over-sedation. This study will conduct a randomized controlled trial with 120 participants, divided into a control group with conventional monitoring and an experimental group using the electronic respiratory sound monitoring system. The study will compare sedation dosage, airway complications, and recovery speed between the two groups, and further analyze the clinical value of the system's parameters. The findings of this study will contribute to improving the safety and precision of sedation during gastrointestinal endoscopy and provide evidence for future clinical guidelines.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital, Taipei, Taiwan

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who undergo routine colonoscopy plus gastroscopy or endoscopic retrograde cholangiopancreatography (ERCP) and require deep sedation

Exclusion criteria

  • Pregnancy
  • Patients diagnosed with sleep apnea or morbid obesity (BMI greater than 40 kg/m2)

Treatment and study plan

routine care without electronic respiratory sound monitoring system

Device

Maintain heart rate between 50-100 bpm; maintain systolic blood pressure between 90-160 mmHg; maintain SpO2 above 94%.

routine care with electronic respiratory sound monitoring system

Device

Maintain heart rate between 50-100 bpm; maintain systolic blood pressure between 90-160 mmHg; maintain SpO2 above 94%; and refer to the following electronic breath sound abnormalities to maintain sedation depth: Maintain respiratory rate (RR) at 12-20 bpm; avoid partial airway obstruction

Primary outcomes

  1. Desaturation

    Time frame: during the procedure

    Incidence and duration of SpO2< 94%

Secondary outcomes

  1. Incidence of airway management for desaturation

    Time frame: during the procedure

    jaw thrust manuever, nasal airway insertion, mask ventilation

  2. Total amount of anesthetics

    Time frame: during the procedure

    Total amount of anesthetics used

Other outcomes

  1. QoR-15 Questionnaire

    Time frame: 24 hours

    QoR-15 Questionnaire

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Metal Industries Research & Development Centre

Registry information

Official study title

Impact of Implementing an Electronic Respiratory Sound Monitoring System for Quality Improvement in Gastrointestinal Endoscopic Sedation: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2025
Registry last updated
Jan 28, 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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