Study of the safety of ventilation through a narrow tube during operation
Conditions
Interventions
None listed
Sponsors
Orbis Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - ASA 1-2 - Planned for operation from orthopaedic, gynaecology or ENT - Aged above 18 years and under 65
Exclusion criteria
Exclusion criteria: - ASA more than 2 - Aged under 18 - Aged above 65 - Respiratory disease - Cardiovascular disease - Smokers - Obese patients - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Demonstrate the safety and efficacy of ventilation with Ventrain® during 5 minutes. Safety is demonstrated if the peak pressure during insufflation does not exceed 25 mm H2O and PEEP is not smaller than -5 mm H2O and not higher than 6 mm H2O. The number of interventions from the safety-person dr. C will be the primary endpoint. We assume that the interventionrate will be less than 15%. Powercalculation As this can be seen as a pilot study and no information is available at this moment. However. the primary outcome is the number of interventions from the safety-person dr. C . We assume that this will be less than 15%. With 20 patients we can exclude the possibility that this failure proportion is higher than 13.9%. One sided tested the CI will be less than 13.9%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measure the different parameters during ventilation with the Ventrain® as there are lung pressure, peak lung pressure, PEEP, capno, oxygen saturation, tension and heart rhythm. | — |
Countries
Netherlands
Outcome results
None listed