Status:
COMPLETED
Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy
Lead Sponsor:
University of Ulm
Conditions:
Hypercapnia
Hypoxia
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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. Th...
Eligibility Criteria
Inclusion
- 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
- Patients with tracheotomy
- Pregnancy
- Intubation assisted endoscopy
- Procedure without sedation
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05972304
Start Date
April 1 2022
End Date
December 1 2022
Last Update
August 2 2023
Active Locations (1)
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1
Universitätsklinikum Ulm
Ulm, Germany