HypoxemiaNCT07487051
THRIVE in Sedated Gastrointestinal Endoscopy
An observational study of Hypoxemia and Gastrointestinal Endoscopy, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia, Gastrointestinal Endoscopy
- What is being tested?
- High-Flow Nasal Oxygen (THRIVE) and Standard Nasal Cannula Oxygen
- Type of treatment
- Medical device
- How many people
- 222 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
Istanbul
About this study
Official title: THRIVE Versus Standard Nasal Cannula for Oxygenation, Oxygen Reserve Index, and Hypoxemia During Sedated Gastrointestinal Endoscopy
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.
Read the 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.
- Conditions
- Hypoxemia, Gastrointestinal Endoscopy
- Being tested
- High-Flow Nasal Oxygen (THRIVE), Standard Nasal Cannula Oxygen
- Keywords
- THRIVE, High-Flow Nasal Oxygen, Procedural Sedation, Gastroscopy, Oxygen Reserve Index, Sedation-related Hypoxemia, Endoscopy Sedation
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow Nasal Oxygen (THRIVE)Device
Also called HFNO
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.
Standard Nasal Cannula OxygenDevice
Also called SNC
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Standard Nasal Cannula Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Proportion of patients requiring any of the following interventions during the procedure: jaw thrust or head extension maneuver, escalation of supplemental oxygen flow, or mask ventilation with 100% oxygen continued until SpO₂ ≥98%. Interventions were triggered by apnea (absence of respiratory activity or loss of ETCO₂ tracing for >20 seconds) or SpO₂ ≤93% for ≥20 seconds.
Measured: From induction of sedation until end of the endoscopic procedure (estimated 10-30 minutes)
Oxygen Reserve Index (ORi) Throughout the Procedure
ORi was continuously monitored using a non-invasive multiwavelength pulse co-oximetry sensor. Values were recorded at baseline, pre-induction, post-induction, during the procedure, and at procedure end. ORi reflects oxygen reserve in the moderate hyperoxic range (PaO₂ 100-200 mmHg) and was compared between groups at each time point.
Measured: Baseline, pre-induction, post-induction, intraoperative, and immediately after procedure completion
Peripheral Oxygen Saturation (SpO₂) Throughout the Procedure
SpO₂ was continuously monitored via pulse oximetry and recorded at baseline, pre-induction, post-induction, during the procedure, and at procedure end. Mean SpO₂ values and the number and duration of desaturation episodes were compared between the THRIVE and standard nasal cannula groups.
Measured: Baseline, pre-induction, post-induction, intraoperative, and immediately after procedure completion
Intraoperative Hemodynamic Stability
Mean arterial pressure (MAP) and heart rate (HR) were recorded at baseline, pre-induction, post-induction, during the procedure, and at procedure end. Hypotension was defined as MAP ≥25% below baseline; hypertension as ≥20% increase in systolic blood pressure from baseline; bradycardia as HR <60 bpm. The incidence of each event was compared between groups.
Measured: Baseline, pre-induction, post-induction, intraoperative, and immediately after procedure completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Jul 2025
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oznur Demiroluk, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- oznur demiroluk, MD, Principal investigator, fatih sultan mehmet research and training hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487051
- Sponsor's protocol ID
- THRIVE-FSM
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No formal data sharing plan has been established at this time. Individual participant data sharing will be considered upon reasonable request, subject to ethical approval and institutional regulations.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THRIVE Versus Standard Nasal Cannula for Oxygenation, Oxygen Reserve Index, and Hypoxemia During Sedated Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT07487051
- Acronym / sponsor ID
- THRIVE-FSM
- Conditions
- Hypoxemia, Gastrointestinal Endoscopy
- Keywords
- THRIVE, High-Flow Nasal Oxygen, Procedural Sedation, Gastroscopy, Oxygen Reserve Index, Sedation-related Hypoxemia, Endoscopy Sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 OxygenAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Flow Nasal Oxygen (THRIVE)Also: HFNOHeated 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. | Device | THRIVE Group (High-Flow Nasal Oxygen) |
| Standard Nasal Cannula OxygenAlso: SNCSupplemental 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. | Device | SNC Group (Standard Nasal Cannula) |
Primary outcome
Incidence of Hypoxemia During Procedural Sedation
Time frame: From induction of sedation until end of the endoscopic procedure (estimated 10-30 minutes)
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.
4 secondary outcomes
Need for Airway Intervention Due to Hypoxemia or Apnea
Time frame: From induction of sedation until end of the endoscopic procedure (estimated 10-30 minutes)
Oxygen Reserve Index (ORi) Throughout the Procedure
Time frame: Baseline, pre-induction, post-induction, intraoperative, and immediately after procedure completion
Peripheral Oxygen Saturation (SpO₂) Throughout the Procedure
Time frame: Baseline, pre-induction, post-induction, intraoperative, and immediately after procedure completion
Intraoperative Hemodynamic Stability
Time frame: Baseline, pre-induction, post-induction, intraoperative, and immediately after procedure completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided. No formal data sharing plan has been established at this time. Individual participant data sharing will be considered upon reasonable request, subject to ethical approval and institutional regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
oznur demiroluk, MD principal investigator
fatih sultan mehmet research and training hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxemia and Gastrointestinal Endoscopy, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hypoxemia During Procedural Sedation (time frame: From induction of sedation until end of the endoscopic procedure (estimated 10-30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.