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

Sponsor
University of Ulm (Other)
Overall Status
Completed
CT.gov ID
NCT05972304
Collaborator
(none)
98
Enrollment
1
Location
2
Arms
8
Actual Duration (Months)
12.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Nasal positive airway System by Vyaire Medical
 N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopic Procedures in High Risk Patients. Endo-Breath-Study
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
Nov 1, 2022
Actual Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

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

Device: Nasal positive airway System by Vyaire Medical
Incidence of Hypercarbia and Hypoxia in interventional group and its monitoring using transcutaneous (SpO2) and (tCO2) Sensor
Other Names:
  • Superno2Va
  • Radiometer TCM 5

    		•
    No Intervention: Control Group

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

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Hypoxia ( SpO2 < 90%, lasting longer than 10 seconds) during the endoscopic procedure [During endoscopic procedure]

    2. Incidence of severe Hypoxia ( SpO2 < 80%, lasting longer than 10 seconds) during the endoscopic procedure [During endoscopic procedure]

    Secondary Outcome Measures

    1. Difference of delta tcpCO2 (transcutaneous pCO2) levels between two groups [During endoscopic procedure]

      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

    2. Number of desaturation episodes (SpO2 < 90%) [During endoscopic procedure]

    3. Interception of the intervention due to insufficient oxygenation [During endoscopic procedure]

    4. The emmergence of serious adverse events [During endoscopic procedure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitätsklinikum Ulm Ulm Germany

    Sponsors and Collaborators

    • University of Ulm

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Seufferlein, Prof. Dr. med. Benjamin Walter, University of Ulm
    ClinicalTrials.gov Identifier:
    NCT05972304
    Other Study ID Numbers:
    • EndoBreath
    First Posted:
    Aug 2, 2023
    Last Update Posted:
    Aug 2, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Hypoxia
    Hypercapnia

    Study Results

    No Results Posted as of Aug 2, 2023