THRIVE Versus Standard Nasal Cannula for Oxygenation, Oxygen Reserve Index, and Hypoxemia During Sedated Gastrointestinal Endoscopy
| Registry | NCT07487051 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 222 (Actual) |
| Sponsor | Fatih Sultan Mehmet Training and Research Hospital (Other) |
| Conditions | Hypoxemia, Gastrointestinal Endoscopy |
| Interventions | High-Flow Nasal Oxygen (THRIVE), Standard Nasal Cannula Oxygen (Device) |
| Dates | start 2025-07-01, primary completion 2025-10-01, completion 2025-10-01, first posted 2026-03-23, last updated 2026-03-23 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Hypoxemia All trials for Gastrointestinal Endoscopy All trials of High-Flow Nasal Oxygen (THRIVE) All trials of Standard Nasal Cannula Oxygen
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.
Procedural sedation for gastrointestinal endoscopy is associated with risks of respiratory depression, airway obstruction, and hypoxemia due to the pharmacological effects of sedative agents. Standard nasal cannula (SNC) oxygen supplementation, while widely used, is limited in its ability to guarantee adequate inspired oxygen concentrations, particularly during apneic episodes.
THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) delivers heated and humidified oxygen at flow rates up to 70 L/min via a non-invasive nasal cannula. The high-flow system generates positive nasopharyngeal pressure, reduces anatomical dead space through a washout effect, increases end-expiratory lung volume, and extends safe apnea time by delaying arterial desaturation. These physiological mechanisms may offer significant advantages over standard low-flow oxygen delivery during sedated endoscopy.
In this single-center prospective observational study, adult patients (age ≥18, ASA I-III, BMI <35 kg/m²) undergoing elective diagnostic gastroscopy under propofol sedation were monitored with continuous SpO₂, ETCO₂, BIS, and non-invasive Oxygen Reserve Index (ORi) monitoring. Supplemental oxygen was provided either via THRIVE at 30 L/min or standard nasal cannula at 10 L/min, based on the attending anesthesiologist's preference. Preoxygenation was initiated 2 minutes before induction and continued until procedure completion. Sedation was maintained with propofol 1-1.5 mg/kg targeting BIS 60-80; fentanyl 0.5-1 mcg/kg was administered when required. Hemodynamic and respiratory parameters were recorded at baseline, pre-induction, post-induction, intraoperatively, and at procedure end. Airway interventions were standardized and applied when apnea lasted ≥20 seconds or SpO₂ dropped ≤93% for ≥20 seconds.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| THRIVE Group (High-Flow Nasal Oxygen) | Device: High-Flow Nasal Oxygen (THRIVE) | Adult patients (age ≥18, ASA I-III, BMI <35 kg/m²) undergoing elective diagnostic gastroscopy under propofol sedation. Supplemental oxygen was provided via a high-flow nasal oxygen system (THRIVE) at 30 L/min, initiated 2 minutes before induction and continued throughout the procedure. Sedation was maintained with propofol 1-1.5 mg/kg targeting BIS 60-80. Fentanyl 0.5-1 mcg/kg was administered if needed. Monitoring included SpO₂, ETCO₂, BIS, and Oxygen Reserve Index (ORi). Primary outcome: incidence of hypoxemia (SpO₂ <93% for ≥20 seconds). Secondary outcomes: need for airway intervention, supplemental oxygen escalation, and ORi/SpO₂ values throughout the procedure. | |
| SNC Group (Standard Nasal Cannula) | Device: Standard Nasal Cannula Oxygen | Adult patients (age ≥18, ASA I-III, BMI <35 kg/m²) undergoing elective diagnostic gastroscopy under propofol sedation. Supplemental oxygen was provided via standard nasal cannula at 10 L/min, initiated 2 minutes before induction and continued throughout the procedure. Sedation was maintained with propofol 1-1.5 mg/kg targeting BIS 60-80. Fentanyl 0.5-1 mcg/kg was administered if needed. Monitoring included SpO₂, ETCO₂, BIS, and Oxygen Reserve Index (ORi). Primary outcome: incidence of hypoxemia (SpO₂ <93% for ≥20 seconds). Secondary outcomes: need for airway intervention, supplemental oxygen escalation, and ORi/SpO₂ values throughout the procedure. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital | Istanbul | Turkey (Türkiye) |