Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy

Study Overview
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Brief Summary
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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
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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

Official Title
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Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopic Procedures in High Risk Patients. Endo-Breath-Study

Conditions
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Hypercapnia, Hypoxia

Intervention / Treatment
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* Device: Nasal positive airway System by Vyaire Medical


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Patients undergoing endoscopic procedures receiving oxygen supplementation through nasal positive airway pressure system ( 10 litters/minute). | Device: Nasal positive airway System by Vyaire Medical<br>* Incidence of Hypercarbia and Hypoxia in interventional group and its monitoring using transcutaneous (SpO2) and (tCO2) Sensor<br>* Other names: Radiometer TCM 5;|
| No Intervention: Control Group<br>Patients undergoing endoscopic procedures receiving conventional oxygen supplementation through nasal cannula (6 litters/minute). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Hypoxia ( SpO2 < 90%, lasting longer than 10 seconds) during the endoscopic procedure |  | During endoscopic procedure | 
| Incidence of severe Hypoxia ( SpO2 < 80%, lasting longer than 10 seconds) during the endoscopic procedure |  | During endoscopic procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of desaturation episodes (SpO2 < 90%) |  | During endoscopic procedure | 
| Interception of the intervention due to insufficient oxygenation |  | During endoscopic procedure | 
| The emmergence of serious adverse events |  | During endoscopic procedure |