Clinical trial NCT05972304: Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy
Official title: Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopic Procedures in High Risk Patients. Endo-Breath-Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercapnia
Hypoxia
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Hypoxia ( SpO2 < 90%, lasting longer than 10 seconds) during the endoscopic procedure
timeFrame: During endoscopic procedure
measure: Incidence of severe Hypoxia ( SpO2 < 80%, lasting longer than 10 seconds) during the endoscopic procedure
timeFrame: During endoscopic procedure
Secondary outcomes:
measure: Difference of delta tcpCO2 (transcutaneous pCO2) levels between two groups
timeFrame: During endoscopic procedure
measure: Number of desaturation episodes (SpO2 < 90%)
timeFrame: During endoscopic procedure
measure: Interception of the intervention due to insufficient oxygenation
timeFrame: During endoscopic procedure
measure: The emmergence of serious adverse events
timeFrame: During endoscopic procedure
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
References: