search
Back to results

Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy (Endo-Breath)

Primary Purpose

Hypercapnia, Hypoxia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Nasal positive airway System by Vyaire Medical
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercapnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ASA III (poorly controlled Diabetes Melitus (DM) or arterial hypertension (HTN), Chronic obstructive Pulmonary Disease (COPD), morbid obesity (BMI≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, End Stage Renal Disease (ESRD), Advanced Liver Disease ( ACLD) ; history (>3 months) of Myocardial Infarction, coronary artery disease (CAD) , transient ischemic attack (TIA), or CAD/stents) ASA IV (recent (<3 months MI, CVA, TIA, or CAD/stents, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, sepsis, ARD or ESRD not undergoing regularly scheduled dialysis Active Malignancy (ECOG Performance >2) Exclusion Criteria: Patients with tracheotomy Pregnancy Intubation assisted endoscopy Procedure without sedation

Sites / Locations

  • Universitätsklinikum Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Patients undergoing endoscopic procedures receiving oxygen supplementation through nasal positive airway pressure system ( 10 litters/minute).

Patients undergoing endoscopic procedures receiving conventional oxygen supplementation through nasal cannula (6 litters/minute).

Outcomes

Primary Outcome Measures

Incidence of Hypoxia ( SpO2 < 90%, lasting longer than 10 seconds) during the endoscopic procedure
Incidence of severe Hypoxia ( SpO2 < 80%, lasting longer than 10 seconds) during the endoscopic procedure

Secondary Outcome Measures

Difference of delta tcpCO2 (transcutaneous pCO2) levels between two groups
Delta tcpCO2 is the difference of tpCO2 values from the beginning of the intervention to the mean tpCO2 levels observed throughout the procedure, between two groups
Number of desaturation episodes (SpO2 < 90%)
Interception of the intervention due to insufficient oxygenation
The emmergence of serious adverse events

Full Information

First Posted
December 29, 2022
Last Updated
August 1, 2023
Sponsor
University of Ulm
search

1. Study Identification

Unique Protocol Identification Number
NCT05972304
Brief Title
Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy
Acronym
Endo-Breath
Official Title
Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopic Procedures in High Risk Patients. Endo-Breath-Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Goal of our study is to investigate whether the implication of nasal positive airway pressure (nPAP) system on patients with high periprocedural risk could significantly lower the incidence of severe hypoxia and hypercarbia. Furthermore, we have set up goals to assess key components and factors, which lead to development of hypercarbia during endoscopy.
Detailed Description
Sedation of high-risk patients resemble a relevant issue in interventional endoscopy. This especially because standard oximetric monitoring displays only hypoxia and not the preceding hypercapnia. Therefore, the question arises whether the implication of a nasal positive airway pressure (nPAP) system can decrease the rate of sedation associated events. The Null Hypothesis: The incidence of hypoxia in interventional group, using nasal positive airway pressure system, in comparison to control group with conventional oxygen supplementation canula is not significant. Alternative Hypothesis: The incidence of hypoxia in interventional group, using nasal positive airway pressure system is significantly lower, than in a control group with conventional oxygen supplementation canula

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnia, Hypoxia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Patients undergoing endoscopic procedures receiving oxygen supplementation through nasal positive airway pressure system ( 10 litters/minute).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients undergoing endoscopic procedures receiving conventional oxygen supplementation through nasal cannula (6 litters/minute).
Intervention Type
Device
Intervention Name(s)
Nasal positive airway System by Vyaire Medical
Other Intervention Name(s)
Superno2Va, Radiometer TCM 5
Intervention Description
Incidence of Hypercarbia and Hypoxia in interventional group and its monitoring using transcutaneous (SpO2) and (tCO2) Sensor
Primary Outcome Measure Information:
Title
Incidence of Hypoxia ( SpO2 < 90%, lasting longer than 10 seconds) during the endoscopic procedure
Time Frame
During endoscopic procedure
Title
Incidence of severe Hypoxia ( SpO2 < 80%, lasting longer than 10 seconds) during the endoscopic procedure
Time Frame
During endoscopic procedure
Secondary Outcome Measure Information:
Title
Difference of delta tcpCO2 (transcutaneous pCO2) levels between two groups
Description
Delta tcpCO2 is the difference of tpCO2 values from the beginning of the intervention to the mean tpCO2 levels observed throughout the procedure, between two groups
Time Frame
During endoscopic procedure
Title
Number of desaturation episodes (SpO2 < 90%)
Time Frame
During endoscopic procedure
Title
Interception of the intervention due to insufficient oxygenation
Time Frame
During endoscopic procedure
Title
The emmergence of serious adverse events
Time Frame
During endoscopic procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA III (poorly controlled Diabetes Melitus (DM) or arterial hypertension (HTN), Chronic obstructive Pulmonary Disease (COPD), morbid obesity (BMI≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, End Stage Renal Disease (ESRD), Advanced Liver Disease ( ACLD) ; history (>3 months) of Myocardial Infarction, coronary artery disease (CAD) , transient ischemic attack (TIA), or CAD/stents) ASA IV (recent (<3 months MI, CVA, TIA, or CAD/stents, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, sepsis, ARD or ESRD not undergoing regularly scheduled dialysis Active Malignancy (ECOG Performance >2) Exclusion Criteria: Patients with tracheotomy Pregnancy Intubation assisted endoscopy Procedure without sedation
Facility Information:
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy

We'll reach out to this number within 24 hrs