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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05972304
Other study ID # EndoBreath
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date December 1, 2022

Study information

Verified date July 2023
Source University of Ulm
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date December 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany Universitätsklinikum Ulm Ulm

Sponsors (1)

Lead Sponsor Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Hypoxia ( SpO2 < 90%, lasting longer than 10 seconds) during the endoscopic procedure During endoscopic procedure
Primary Incidence of severe Hypoxia ( SpO2 < 80%, lasting longer than 10 seconds) during the endoscopic procedure During endoscopic procedure
Secondary 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 During endoscopic procedure
Secondary Number of desaturation episodes (SpO2 < 90%) During endoscopic procedure
Secondary Interception of the intervention due to insufficient oxygenation During endoscopic procedure
Secondary The emmergence of serious adverse events During endoscopic procedure
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