Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT05972304
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2022-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy
Sponsor:
University of Ulm
Organization:
Study Overview
Official Title:
Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopic Procedures in High Risk Patients. Endo-Breath-Study
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Endo-Breath
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: