HypoxemiaNCT07234188
POM vs HFNC for Hypoxemia Prevention in Children
A study testing Procedural Oxygen Mask and High-Flow Nasal Cannula in people with Hypoxemia, run by Bedirhan Günel at 1 site in Turkey (Türkiye).
Trial summary
Upper gastrointestinal endoscopy is a commonly performed diagnostic and therapeutic procedure in children, allowing evaluation of the esophagus, stomach, and duodenum, as well as interventions such as biopsy, foreign body removal, and polypectomy. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Procedural Oxygen Mask and High-Flow Nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2026to 21 May 2026
- Phase
- Interventional
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who consented to participate in the study
- Aged between 6 and 16 years
- Body weight >30 kg
- ASA physical status I-II
- Children scheduled to undergo procedural sedation for non-emergency upper gastrointestinal endoscopy
Who cannot join
- Lack of parental consent or refusal to sign the participant consent form
- History of endotracheal intubation within the past 3 months
- History of lower respiratory tract infection within the past 3 months
- History of intensive care unit (ICU) admission within the past 3 months
- Presence of a tracheostomy
- History of tracheostomy placement
Show all 10Show fewer
- Patients with oxygen dependency due to any underlying disease
- Known pulmonary or cardiac disease
- Known congenital craniofacial anomalies
- Congenital or acquired upper airway malformations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a Procedural Oxygen Mask and High-Flow Nasal Cannula for the Prevention of Hypoxemia During Pediatric Upper Gastrointestinal Endoscopy Under Sedation: A Single-Center Randomized Controlled Pilot Trial
Upper gastrointestinal endoscopy is a commonly performed diagnostic and therapeutic procedure in children, allowing evaluation of the esophagus, stomach, and duodenum, as well as interventions such as biopsy, foreign body removal, and polypectomy. Sedation is routinely used, often at greater depths than for standard examinations. Due to anatomical and physiological differences, including smaller airway diameter, higher oxygen consumption, and lower functional residual capacity, pediatric patients are at higher risk of airway obstruction, hypoxemia, and hypoventilation compared to adults. The passage of the endoscope through the mouth further limits airway access and increases the risk of desaturation. Oxygenation during pediatric endoscopy is typically supported using nasal cannulas, high-flow systems, or procedural oxygen masks (POM™). This pilot randomized study aims to compare POM™ and high-flow nasal cannula in preventing hypoxemia during sedated pediatric upper gastrointestinal endoscopy, contributing evidence for safer sedation and airway management practices in children.
- Conditions
- Hypoxemia
- Being tested
- Procedural Oxygen Mask, High-Flow Nasal Cannula
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedural Oxygen MaskDevice
Delivers oxygen through the mouth and nose during sedation while allowing endoscope passage.
High-Flow Nasal CannulaDevice
Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Experimental | Oxygen delivered via Procedural Oxygen Mask (POM™) at a fixed flow of 15 L/min (approx. FiO₂ 95%) throughout the procedure. Receives: Device: Procedural Oxygen Mask |
| Group H | Active comparator | Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure. Receives: Device: High-Flow Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest SpO₂ level during procedure
The lowest peripheral oxygen saturation (SpO₂) recorded between the initiation of sedation and the removal of the gastroscope was defined as the primary outcome.
It was measured via continuous pulse oximetry, and when SpO₂ fluctuated, the value maintained for more than 10 seconds was recorded.
Measured: From the start of sedation to end of endoscopy (typically 5-20 minutes)
Secondary outcomes (7)
Incidence of hypoxemia
Defined as any drop in SpO₂ <94% lasting for at least 10 seconds. Based on pulse oximetry recordings.
Measured: During endoscopic procedure (from sedation start to endoscope removal)
Number of hypoxemic episodes
Recurrent desaturations: counted when SpO₂ falls <94% again, at least 30 seconds after a return to ≥94%.
Measured: During endoscopic procedure
Duration of hypoxemia (in seconds)
Time required for SpO₂ to return to ≥94% after each episode of desaturation (<94%).
Measured: During endoscopic procedure
Airway interventions
Number of occurrences requiring airway maneuvers (chin lift, jaw thrust, or mask ventilation).
Measured: During endoscopic procedure
Hemodynamic complications
Incidence of hypotension (>20% drop from baseline systolic BP), hypertension (>20% increase), bradycardia or tachycardia per age-specific thresholds.
Measured: During endoscopic procedure
Gastroenterologist satisfaction score
Rated from 0 (poor sedation, interrupted) to 10 (optimal sedation).
Measured: During endoscopic procedure
Incidence of Device Repositioning
Adjustment of POM™ or HFNC due to displacement, leakage, or malfunction.
Measured: During endoscopic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start4 Mar 2026
- Primary completion21 May 2026
- Study completion21 May 2026
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bedirhan Günel
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Bedirhan Günel, Kocaeli City Hospital
- Investigators
- Bedirhan Günel, MD, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234188
- Sponsor's protocol ID
- KSH-ANREA-BG-09
- Status last verified
- May 2026
- First submitted
- 14 Nov 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Procedural Oxygen Mask and High-Flow Nasal Cannula for the Prevention of Hypoxemia During Pediatric Upper Gastrointestinal Endoscopy Under Sedation: A Single-Center Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07234188
- Acronym / sponsor ID
- KSH-ANREA-BG-09
- Conditions
- Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bedirhan GünelOther government
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 18 Nov 2025 (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.
Upper gastrointestinal endoscopy is a commonly performed diagnostic and therapeutic procedure in children, allowing evaluation of the esophagus, stomach, and duodenum, as well as interventions such as biopsy, foreign body removal, and polypectomy. Sedation is routinely used, often at greater depths than for standard examinations. Due to anatomical and physiological differences, including smaller airway diameter, higher oxygen consumption, and lower functional residual capacity, pediatric patients are at higher risk of airway obstruction, hypoxemia, and hypoventilation compared to adults. The passage of the endoscope through the mouth further limits airway access and increases the risk of desaturation. Oxygenation during pediatric endoscopy is typically supported using nasal cannulas, high-flow systems, or procedural oxygen masks (POM™). This pilot randomized study aims to compare POM™ and high-flow nasal cannula in preventing hypoxemia during sedated pediatric upper gastrointestinal endoscopy, contributing evidence for safer sedation and airway management practices in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P | Experimental | Device: Procedural Oxygen MaskOxygen delivered via Procedural Oxygen Mask (POM™) at a fixed flow of 15 L/min (approx. FiO₂ 95%) throughout the procedure. |
| Group H | Active comparator | Device: High-Flow Nasal CannulaOxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients who consented to participate in the study
- Aged between 6 and 16 years
- Body weight >30 kg
- ASA physical status I-II
- Children scheduled to undergo procedural sedation for non-emergency upper gastrointestinal endoscopy
Key exclusion criteria (10 listed)
- Lack of parental consent or refusal to sign the participant consent form
- History of endotracheal intubation within the past 3 months
- History of lower respiratory tract infection within the past 3 months
- History of intensive care unit (ICU) admission within the past 3 months
- Presence of a tracheostomy
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 |
|---|---|---|
| Procedural Oxygen MaskDelivers oxygen through the mouth and nose during sedation while allowing endoscope passage. | Device | Group P |
| High-Flow Nasal CannulaOxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure. | Device | Group H |
Primary outcome
Lowest SpO₂ level during procedure
Time frame: From the start of sedation to end of endoscopy (typically 5-20 minutes)
The lowest peripheral oxygen saturation (SpO₂) recorded between the initiation of sedation and the removal of the gastroscope was defined as the primary outcome. It was measured via continuous pulse oximetry, and when SpO₂ fluctuated, the value maintained for more than 10 seconds was recorded.
7 secondary outcomes
Incidence of hypoxemia
Time frame: During endoscopic procedure (from sedation start to endoscope removal)
Number of hypoxemic episodes
Time frame: During endoscopic procedure
Duration of hypoxemia (in seconds)
Time frame: During endoscopic procedure
Airway interventions
Time frame: During endoscopic procedure
Hemodynamic complications
Time frame: During endoscopic procedure
Gastroenterologist satisfaction score
Time frame: During endoscopic procedure
Incidence of Device Repositioning
Time frame: During endoscopic procedure
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 22 May 2026.
- Individual participant dataSharing planned: No. Data will be shared upon reasonable request.
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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.
Bedirhan Günel, MD principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedural Oxygen Mask and High-Flow Nasal Cannula in people with Hypoxemia, run by Bedirhan Günel 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 5 inclusion and 10 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 22 May 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?
Lowest SpO₂ level during procedure (time frame: From the start of sedation to end of endoscopy (typically 5-20 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 22 May 2026.