HypoxemiaNCT07234175
Procedural Oxygen Mask vs Nasal Cannula in Pediatric Endoscopy
A study testing Procedural Oxygen Mask and 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, when necessary, therapeutic procedure in pediatric patients for the evaluation of the esophagus, stomach, and duodenum. Additional interventions such as biopsy, foreign body removal, or polypectomy can also be performed during the same session. 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 Nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2025to 3 Mar 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 Nasal Cannula for the Prevention of Hypoxemia During Pediatric Upper Gastrointestinal Endoscopy Under Sedation: A Single-Center Prospective Randomized Controlled Trial
Upper gastrointestinal endoscopy is a commonly performed diagnostic and, when necessary, therapeutic procedure in pediatric patients for the evaluation of the esophagus, stomach, and duodenum. Additional interventions such as biopsy, foreign body removal, or polypectomy can also be performed during the same session. Sedation is generally required during the procedure, and the depth of sedation is often greater than that used for routine examinations.
Because of anatomical and physiological differences in children-such as smaller airway diameter, higher oxygen consumption, and lower functional residual capacity-the risks of upper airway obstruction, hypoxemia, and hypoventilation are higher than in adults. The passage of the endoscope through the mouth, combined with the respiratory depressant effects of sedatives and the smaller airway diameter, increases the likelihood of hypoxemia and limits the anesthesia team's access to the airway. Therefore, maintaining airway stability and optimizing oxygenation during sedation are particularly critical in pediatric patients.
Read more
Currently, several oxygen delivery methods are used during upper gastrointestinal endoscopy, including conventional nasal cannulas, high-flow nasal oxygen systems, and procedural oxygen masks. The Procedural Oxygen Mask (POM™) is a specially designed device that delivers oxygen through both the mouth and nose while allowing endoscope passage and continuous capnography monitoring. Previous studies in adults have shown that the use of POM™ or high-flow nasal oxygen reduces the incidence of hypoxemia during endoscopy. However, in children, there is a lack of randomized controlled trials directly comparing POM™ with nasal cannula use.
This single-center prospective randomized controlled trial aims to compare the effectiveness of the Procedural Oxygen Mask (POM™) and nasal cannula in preventing hypoxemia during pediatric upper gastrointestinal endoscopy under sedation. The findings are expected to contribute to safer sedation practices and improved airway management strategies in pediatric endoscopic procedures.
- Conditions
- Hypoxemia
- Being tested
- Procedural Oxygen Mask, 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.
Nasal CannulaDevice
Provides standard oxygen delivery through the nostrils during sedation.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Experimental | Participants will receive oxygen via a Procedural Oxygen Mask (POM) at a flow rate of 5 L/min during upper gastrointestinal endoscopy under sedation. Receives: Device: Procedural Oxygen Mask |
| Group N | Active comparator | Participants will receive oxygen via a conventional nasal cannula at a flow rate of 5 L/min during upper gastrointestinal endoscopy under sedation. Receives: Device: 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 (6)
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
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 start20 Nov 2025
- Primary completion3 Mar 2026
- Study completion3 Mar 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
- 114 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
- NCT07234175
- Sponsor's protocol ID
- KSH-ANREA-BG-08
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Procedural Oxygen Mask and Nasal Cannula for the Prevention of Hypoxemia During Pediatric Upper Gastrointestinal Endoscopy Under Sedation: A Single-Center Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07234175
- Acronym / sponsor ID
- KSH-ANREA-BG-08
- Conditions
- Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Bedirhan GünelOther government
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 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, when necessary, therapeutic procedure in pediatric patients for the evaluation of the esophagus, stomach, and duodenum. Additional interventions such as biopsy, foreign body removal, or polypectomy can also be performed during the same session. Sedation is generally required during the procedure, and the depth of sedation is often greater than that used for routine examinations.
Because of anatomical and physiological differences in children-such as smaller airway diameter, higher oxygen consumption, and lower functional residual capacity-the risks of upper airway obstruction, hypoxemia, and hypoventilation are higher than in adults. The passage of the endoscope through the mouth, combined with the respiratory depressant effects of sedatives and the smaller airway diameter, increases the likelihood of hypoxemia and limits the anesthesia team's access to the airway. Therefore, maintaining airway stability and optimizing oxygenation during sedation are particularly critical in pediatric patients.
Currently, several oxygen delivery methods are used during upper gastrointestinal endoscopy, including conventional nasal cannulas, high-flow nasal oxygen systems, and procedural oxygen masks. The Procedural Oxygen Mask (POM™) is a specially designed device that delivers oxygen through both the mouth and nose while allowing endoscope passage and continuous capnography monitoring. Previous studies in adults have shown that the use of POM™ or high-flow nasal oxygen reduces the incidence of hypoxemia during endoscopy. However, in children, there is a lack of randomized controlled trials directly comparing POM™ with nasal cannula use.
This single-center prospective randomized controlled trial aims to compare the effectiveness of the Procedural Oxygen Mask (POM™) and nasal cannula in preventing hypoxemia during pediatric upper gastrointestinal endoscopy under sedation. The findings are expected to contribute to safer sedation practices and improved airway management strategies in pediatric endoscopic procedures.
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 MaskParticipants will receive oxygen via a Procedural Oxygen Mask (POM) at a flow rate of 5 L/min during upper gastrointestinal endoscopy under sedation. |
| Group N | Active comparator | Device: Nasal CannulaParticipants will receive oxygen via a conventional nasal cannula at a flow rate of 5 L/min during upper gastrointestinal endoscopy under sedation. |
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 |
| Nasal CannulaProvides standard oxygen delivery through the nostrils during sedation. | Device | Group N |
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.
6 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
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 5 Mar 2026.
- Individual participant dataSharing planned: No. Data will be made available 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 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 5 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?
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 5 Mar 2026.