Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:49 AM
Study NCT ID:
NCT07487051
Status:
COMPLETED
Last Update Posted:
2026-03-23
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
THRIVE in Sedated Gastrointestinal Endoscopy
Sponsor:
Fatih Sultan Mehmet Training and Research Hospital
Organization:
Study Overview
Official Title:
THRIVE Versus Standard Nasal Cannula for Oxygenation, Oxygen Reserve Index, and Hypoxemia During Sedated Gastrointestinal Endoscopy
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: