Study of the change in Intra-Abdominal Pressure during spine surgery in the prone positio

Completed

Conditions: intra-abdominal pressure
pressure within the abdominal cavity
10009720

Registration Number: NL-OMON49958

Lead Sponsor: Ergotrics nv

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Age 18-80 at time of surgery
Subject planned to undergo spine surgery in prone position
Subject planned to have transurethral bladder catheter during surgery
Body weight * 120kg

Exclusion Criteria

Abdominal or urethral surgery during past 12 months.
Contraindication to use of transurethral bladder catheter
History of recent (<3 months) urinary tract or bladder infection.
Known allergy to IPS material
Current systemic infection or local infection
Current known pregnancy
Subject is participating in an investigational study
Coagulation Issues/disorders

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in Intra-Abdominal Pressure (IAP) caused by inflation of the IPS<br /><br>(IAP before inflation versus IAP after inflation of the IPS) with the subject<br /><br>under general anesthesia in prone position.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change in IAP over time (supine before proning, prone before IPS inflation,<br /><br>prone after IPS inflation, prone 45 minutes after IPS inflation, at end of<br /><br>surgery and supine after regaining consciousness from anesthesia).<br /><br>Impact of BMI on IAP change when using the IPS<br /><br>Impact of body weight on IAP change when using the IPS<br /><br>Impact of body morphology on IAP change when using the IPS<br /><br>Impact of delta IAP (difference between the end-inspiratory and the<br /><br>end-expiratory IAP) at baseline on IAP change.<br /><br>Blood loss and correlation with IAP<br /><br>Serious adverse events at 48 hours post procedure</p><br>