CompletedNot Applicable

THRIVE in Sedated Gastrointestinal Endoscopy

Turkey (Türkiye)222 participantsStarted 2025-07-01

Plain-language summary

This prospective observational study aims to evaluate the effectiveness of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) compared to standard nasal cannula (SNC) oxygen supplementation in patients undergoing elective diagnostic gastroscopy under propofol sedation. The primary outcome is the incidence of hypoxemia (SpO₂ \<93% for ≥20 seconds) during the procedure. Secondary outcomes include the need for airway intervention, Oxygen Reserve Index (ORi) values, peripheral oxygen saturation (SpO₂) levels, and hemodynamic parameters recorded throughout the procedure. Oxygen delivery method was selected by the attending anesthesia provider independent of the study team.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years * ASA physical status I-III * Body mass index (BMI) \<35 kg/m² * Scheduled for elective diagnostic gastroscopy under propofol sedation * Baseline SpO₂ \>93% on room air prior to the procedure * Hemoglobin level ≥10.0 g/dL prior to the procedure * Willing and able to provide written informed consent Exclusion Criteria: * Severe chronic pulmonary disease (e.g., COPD, interstitial lung disease) * Severe chronic cardiac disease * BMI ≥35 kg/m² * Pregnancy * History of facial or oropharyngeal surgery * Baseline SpO₂ ≤93% on room air prior to the procedure * Hemoglobinopathy * Hemoglobin level \<10.0 g/dL prior to the procedure

What they're measuring

Incidence of Hypoxemia During Procedural Sedation

Timeframe: From induction of sedation until end of the endoscopic procedure (estimated 10-30 minutes)

Trial details

NCT IDNCT07487051

SponsorFatih Sultan Mehmet Training and Research Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-01