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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Patients undergoing endoscopic procedures receiving oxygen supplementation through nasal positive airway pressure system ( 10 litters/minute). |
|
| Control Group | No Intervention | Patients undergoing endoscopic procedures receiving conventional oxygen supplementation through nasal cannula (6 litters/minute). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal positive airway System by Vyaire Medical | Device | Incidence of Hypercarbia and Hypoxia in interventional group and its monitoring using transcutaneous (SpO2) and (tCO2) Sensor |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hypoxia ( SpO2 < 90%, lasting longer than 10 seconds) during the endoscopic procedure | During endoscopic procedure | |
| Incidence of severe Hypoxia ( SpO2 < 80%, lasting longer than 10 seconds) during the endoscopic procedure | During endoscopic procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of desaturation episodes (SpO2 < 90%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Ulm | Ulm | Germany |
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| ID | Term |
|---|---|
| D006935 | Hypercapnia |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| During endoscopic procedure |
| Interception of the intervention due to insufficient oxygenation | During endoscopic procedure |
| The emmergence of serious adverse events | During endoscopic procedure |