Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy

Hypoxia Clinical Trial

— Endo-Breath  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05972304
• Other study ID #: EndoBreath
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2023
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercapnia
• Hypoxia

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Hypoxia ( SpO2 < 90%, lasting longer than 10 seconds) during the endoscopic procedure		During endoscopic procedure
Primary	Incidence of severe Hypoxia ( SpO2 < 80%, lasting longer than 10 seconds) during the endoscopic procedure		During endoscopic procedure
Secondary	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
Secondary	Number of desaturation episodes (SpO2 < 90%)		During endoscopic procedure
Secondary	Interception of the intervention due to insufficient oxygenation		During endoscopic procedure
Secondary	The emmergence of serious adverse events		During endoscopic procedure