NCT05972304

Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypercapnia
• Hypoxia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-11-01
• Completion: 2022-12-01
• First posted: 2023-08-02
• Last updated: 2023-08-02

Locations

1 site across 1 country: Germany