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

Study of the change in Intra-Abdominal Pressure during spine surgery in the prone position - SIAP - Spine Intra-Abdominal Pressure study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49958

Enrollment

Registered

2020-05-27

Start date

2020-11-24

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intra-abdominal pressure pressure within the abdominal cavity

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Abdominal or urethral surgery during past 12 months. Contraindication to use of transurethral bladder catheter History of recent (

Design outcomes

Primary

Measure	Time frame
The change in Intra-Abdominal Pressure (IAP) caused by inflation of the IPS (IAP before inflation versus IAP after inflation of the IPS) with the subject under general anesthesia in prone position.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results