Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy

Not Applicable

Completed

• Conditions: Hypoxia; Hypercapnia
• Interventions: Device: Nasal positive airway System by Vyaire Medical

• Registration Number: NCT05972304
• Lead Sponsor: University of Ulm

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

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-01
• Study First Submitted: 2022-12-29
• Status Verified: 2023-07
• Study First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-01
• Study First Posted: 2023-08-02
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Nasal positive airway System by Vyaire Medical	Patients undergoing endoscopic procedures receiving oxygen supplementation through nasal positive airway pressure system ( 10 litters/minute).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Interception of the intervention due to insufficient oxygenation	During endoscopic procedure
The emmergence of serious adverse events	During endoscopic procedure
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
Number of desaturation episodes (SpO2 < 90%)	During endoscopic procedure

Trial Locations

Locations (1)

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany