Evaluation of the Efficacy and Safety of High-Flow Oxygen Therapy Compared With a Nasal Positive Airway Pressure (nPAP) Mask Using Transcutaneous Capnometry During Endoscopic Procedures in High-Risk Patients (HiPERion)

November 6, 2026 updated by: Thomas Seufferlein, University of Ulm

The HiPERion Trial is a prospective, randomized, controlled, non-inferiority study designed to compare the efficacy and safety of two oxygen and respiratory support methods during sedated endoscopic procedures in patients at increased risk of respiratory complications.

Patients with significant pre-existing medical conditions (American Society of Anesthesiologists [ASA] physical status III or IV) have an increased risk of breathing-related complications during endoscopic procedures performed under sedation. These complications include low blood oxygen levels (hypoxemia) and elevated carbon dioxide levels in the blood (hypercapnia).

The study will compare two respiratory support methods: high-flow nasal cannula (HFNC) oxygen therapy and a nasal positive airway pressure (nPAP) system using the SuperNO2VA mask. Both methods are used to support breathing and maintain adequate oxygen levels during medical procedures. However, they differ in their technical approach and in the way they support ventilation.

A total of 140 adult patients undergoing diagnostic or therapeutic endoscopic procedures lasting more than 15 minutes will be enrolled at the University Hospital Ulm, Germany. Eligible participants will be randomly assigned to receive either HFNC oxygen therapy or respiratory support via the nPAP mask during the procedure.

Throughout the endoscopic procedure, patients will receive standard clinical monitoring, including measurement of oxygen saturation, heart rate, and blood pressure. In addition, carbon dioxide levels will be continuously monitored using a non-invasive transcutaneous capnometry sensor attached to the patient's forehead. This method allows continuous measurement of carbon dioxide levels through the skin without the need for additional blood sampling.

The primary objective is to compare the occurrence of hypoxemic events between the two respiratory support methods. Hypoxemia is defined as a decrease in oxygen saturation below 90% lasting more than 10 seconds. Severe hypoxemic events, defined as a decrease in oxygen saturation below 80% lasting more than 10 seconds, will also be assessed.

Secondary objectives include comparing changes in transcutaneous carbon dioxide levels during the procedure, the number of interventions required to maintain an open airway or optimize respiratory support, and the occurrence of adverse events.

The study aims to determine whether respiratory support using the nPAP mask is not inferior to HFNC oxygen therapy in terms of safety and prevention of hypoxemic events during endoscopic procedures in high-risk patients. The findings may help identify an effective and safe respiratory support strategy for this patient population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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 (Estimated)

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.
140

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 Locations

  • Germany
      • Ulm, Germany, 89081
        • University Hospital Ulm

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 18 years or older.
  • American Society of Anesthesiologists (ASA) physical status III or IV.
  • Patients undergoing diagnostic or therapeutic endoscopic procedures with an expected duration of more than 15 minutes.
  • Written informed consent to participate in the study.

Exclusion Criteria:

  • Patients unable or unwilling to provide informed consent.
  • Known pregnancy.
  • Intolerance or contraindications to sedation.

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: Other
  • 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: HFNC Group

High-Flow Nasal Cannula (HFNC) Oxygen Therapy
Device: High-Flow Nasal Cannula (HFNC) Oxygen Therapy

Patients assigned to the HFNC group will receive high-flow nasal cannula oxygen therapy during the endoscopic procedure. The oxygen flow rate will be set at 40 L/min with an inspired oxygen concentration (FiO₂) of 40%. Transcutaneous carbon dioxide levels will be continuously monitored using a non-invasive forehead sensor. Standard monitoring of peripheral oxygen saturation (SpO₂), heart rate, and blood pressure will be performed throughout the procedure.
Active Comparator: nPAP Group

Nasal Positive Airway Pressure (nPAP) Using the SuperNO2VA Mask
Device: nPAP

Patients assigned to the nPAP group will receive respiratory support using a nasal positive airway pressure (nPAP) system with the SuperNO2VA nasal mask throughout the endoscopic procedure. Transcutaneous carbon dioxide levels will be continuously monitored using a non-invasive forehead sensor. Standard monitoring of peripheral oxygen saturation (SpO₂), heart rate, and blood pressure will be performed throughout 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
Number of Hypoxemic Events
Time Frame: During the endoscopic procedure.

Number of hypoxemic events, defined as a peripheral oxygen saturation (SpO₂) below 90% lasting more than 10 seconds, during the endoscopic procedure.
During the endoscopic procedure.
Number of Severe Hypoxemic Events
Time Frame: During the endoscopic procedure.

Number of severe hypoxemic events, defined as a peripheral oxygen saturation (SpO₂) below 80% lasting more than 10 seconds, during the endoscopic procedur
During the endoscopic procedure.

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
Change in Transcutaneous Carbon Dioxide Levels (tcPCO₂)
Time Frame: During the endoscopic procedure.

Difference between the initial transcutaneous carbon dioxide level (tcPCO₂) and the mean tcPCO₂ level measured during the endoscopic procedure. Continuous non-invasive monitoring will be performed using a transcutaneous forehead sensor.
During the endoscopic procedure.
Number of Airway Support Interventions
Time Frame: During the endoscopic procedure.

Number of airway support interventions required during the endoscopic procedure, including head repositioning and repositioning or adjustment of the nPAP mask or HFNC nasal cannula.
During the 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.
University of Ulm

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.
October 13, 2026

Primary Completion (Estimated)

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.
March 13, 2027

Study Completion (Estimated)

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.
June 13, 2027

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 6, 2026

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 6, 2026

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 12, 2026

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.
November 12, 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.
November 6, 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.
October 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.
  • 20/25 FSt/Sta Ulm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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