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

University of Ulm

Status: Completed

Conditions: Hypercapnia; Hypoxia

Treatments: Device: Nasal positive airway System by Vyaire Medical

Study type: Interventional

Funder types: Other

Identifiers

NCT05972304

EndoBreath

Details and patient eligibility

About

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.

Full 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

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

Device: Nasal positive airway System by Vyaire Medical

Control Group

No Intervention group

Description:

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