THRIVE in Sedated Gastrointestinal Endoscopy

NCT07487051 | Completed

• 1 other identifier: THRIVE-FSM
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia; Gastrointestinal Endoscopy

Keywords

THRIVE; High-Flow Nasal Oxygen; Procedural Sedation; Gastroscopy; Oxygen Reserve Index; Sedation-related Hypoxemia; Endoscopy Sedation

Outcome Measures

Primary Outcomes (1)

• Incidence of Hypoxemia During Procedural Sedation

  Hypoxemia was defined as peripheral oxygen saturation (SpO₂) falling below 93% for a duration of ≥20 seconds, as measured by continuous pulse oximetry. The proportion of patients experiencing at least one hypoxemic episode was compared between the THRIVE and standard nasal cannula groups.

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

Secondary Outcomes (4)

• Need for Airway Intervention Due to Hypoxemia or Apnea

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

• Oxygen Reserve Index (ORi) Throughout the Procedure

  Baseline, pre-induction, post-induction, intraoperative, and immediately after procedure completion

• Peripheral Oxygen Saturation (SpO₂) Throughout the Procedure

  Baseline, pre-induction, post-induction, intraoperative, and immediately after procedure completion

• Intraoperative Hemodynamic Stability

  Baseline, pre-induction, post-induction, intraoperative, and immediately after procedure completion

Study Arms (2)

THRIVE Group (High-Flow Nasal Oxygen)

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.

Device: High-Flow Nasal Oxygen (THRIVE)

SNC Group (Standard Nasal Cannula)

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.

Device: Standard Nasal Cannula Oxygen

Interventions

High-Flow Nasal Oxygen (THRIVE) DEVICE

Heated and humidified high-flow nasal oxygen was delivered via a THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) system at a flow rate of 30 L/min with FiO₂ of 1.0, initiated 2 minutes prior to propofol induction and maintained continuously until the end of the procedure. The system generates nasopharyngeal positive pressure and reduces dead space, thereby supporting oxygenation and delaying desaturation during apneic episodes.

Also known as: HFNO

THRIVE Group (High-Flow Nasal Oxygen)

Standard Nasal Cannula Oxygen DEVICE

Supplemental oxygen was administered via a standard nasal cannula at a flow rate of 10 L/min, initiated 2 minutes prior to propofol induction and maintained continuously until the end of the procedure. This represents the standard of care for oxygen supplementation during procedural sedation for gastrointestinal endoscopy.

Also known as: SNC

SNC Group (Standard Nasal Cannula)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 years and older with ASA physical status I-III and BMI \<35 kg/m², scheduled for elective diagnostic gastroscopy under propofol sedation at a single tertiary care center. Patients with severe cardiopulmonary disease, pregnancy, prior facial or oropharyngeal surgery, baseline hypoxemia, hemoglobinopathy, or significant anemia were excluded. Supplemental oxygen delivery method (THRIVE vs. standard nasal cannula) was determined by the anesthesia provider independently of the study team.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• oznur demiroluk, MD

  fatih sultan mehmet research and training hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 23, 2026
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

TU (1)