POM vs HFNC for Hypoxemia Prevention in Children

May 21, 2026 updated by: Bedirhan Günel

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Izmit
      • Kocaeli, Izmit, Turkey (Türkiye), 41100
        • Kocaeli City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Patients with oxygen dependency due to any underlying disease
  • Known pulmonary or cardiac disease
  • Known congenital craniofacial anomalies
  • Congenital or acquired upper airway malformations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group P
Oxygen delivered via Procedural Oxygen Mask (POM™) at a fixed flow of 15 L/min (approx. FiO₂ 95%) throughout the procedure.
Device: Procedural Oxygen Mask
Delivers oxygen through the mouth and nose during sedation while allowing endoscope passage.
Active Comparator: Group H
Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure.
Device: High-Flow Nasal Cannula
Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From the start of sedation to end of endoscopy (typically 5-20 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of hypoxemia
Time Frame: During endoscopic procedure (from sedation start to endoscope removal)
Defined as any drop in SpO₂ <94% lasting for at least 10 seconds. Based on pulse oximetry recordings.
During endoscopic procedure (from sedation start to endoscope removal)
Number of hypoxemic episodes
Time Frame: During endoscopic procedure
Recurrent desaturations: counted when SpO₂ falls <94% again, at least 30 seconds after a return to ≥94%.
During endoscopic procedure
Duration of hypoxemia (in seconds)
Time Frame: During endoscopic procedure
Time required for SpO₂ to return to ≥94% after each episode of desaturation (<94%).
During endoscopic procedure
Airway interventions
Time Frame: During endoscopic procedure
Number of occurrences requiring airway maneuvers (chin lift, jaw thrust, or mask ventilation).
During endoscopic procedure
Hemodynamic complications
Time Frame: During endoscopic procedure
Incidence of hypotension (>20% drop from baseline systolic BP), hypertension (>20% increase), bradycardia or tachycardia per age-specific thresholds.
During endoscopic procedure
Gastroenterologist satisfaction score
Time Frame: During endoscopic procedure
Rated from 0 (poor sedation, interrupted) to 10 (optimal sedation).
During endoscopic procedure
Incidence of Device Repositioning
Time Frame: During endoscopic procedure
Adjustment of POM™ or HFNC due to displacement, leakage, or malfunction.
During endoscopic procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bedirhan Günel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bedirhan Günel, MD, Kocaeli City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 21, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 21, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KSH-ANREA-BG-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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