Investigation of the safety of ventilation with Ventrain in patients during a planned operatio
Withdrawn
- Conditions
- Study of the safety of ventilation through a narrow tube during operation10046304
- Registration Number
- NL-OMON40890
- Lead Sponsor
- Orbis Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
- ASA 1-2
- Planned for operation from orthopaedic, gynaecology or ENT
- Aged above 18 years and under 65
Exclusion Criteria
- ASA more than 2
- Aged under 18
- Aged above 65
- Respiratory disease
- Cardiovascular disease
- Smokers
- Obese patients
- Pregnancy
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Demonstrate the safety and efficacy of ventilation with Ventrain® during 5<br /><br>minutes. Safety is demonstrated if the peak pressure during insufflation does<br /><br>not exceed 25 mm H2O and PEEP is not smaller than -5 mm H2O and not higher than<br /><br>6 mm H2O. The number of interventions from the safety-person dr. C will be the<br /><br>primary endpoint. We assume that the interventionrate will be less than 15%.<br /><br><br /><br>Powercalculation<br /><br>As this can be seen as a pilot study and no information is available at this<br /><br>moment.<br /><br>However. the primary outcome is the number of interventions from the<br /><br>safety-person dr. C . We assume that this will be less than 15%. With 20<br /><br>patients we can exclude the possibility that this failure proportion is higher<br /><br>than 13.9%. One sided tested the CI will be less than 13.9%. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Measure the different parameters during ventilation with the Ventrain® as there<br /><br>are lung pressure, peak lung pressure, PEEP, capno, oxygen saturation, tension<br /><br>and heart rhythm.</p><br>