Changes of Intra Abdominal Pressure During Surgeries in Prone Position as a Marker of Renal Damage

Recruiting

• Conditions: Spine Surgery; Intraabdominal Hypertension; Prone Postion
• Interventions: Device: Intra abdominal pressure measurement

• Registration Number: NCT05626868
• Lead Sponsor: Medical University of Warsaw

Brief Summary

Background: Patients undergoing surgical operations in prone position do not have a measure of intra abdominal pressure as a standard procedure. Many of them could have elevated values of this parameter and could be exposed to possible renal damage due to a stiffening of the abdominal muscles while being positioned prone.

Purpose of study: Intraoperative intrabdominal pressure measurement and evaluation of correlation with possible postsurgical complications.

Methodology: Electronic device able to measure intra abdominal pressure is connected between a Foley catheter and a urinary collecting bag. During the procedure, values of the intra abdominal pressure are displayed on a monitor next to anaesthetic machine in real time. The numbers representing the pressure in mmHG are assessed and recorded.

Discussion: Possible correlation between intra abdominal hypertension and postsurgical complications in patients operated in prone position could be a foundation to further clinical trials and presurgical assessment of intraabdominal pressure.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-15
• Last Update Submitted: 2022-11-15
• Study First Posted: 2022-11-25
• Last Update Posted: 2022-11-25
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Consent to participate in the study
• Patients qualified for surgical stabilization of the spine in prone position

Exclusion Criteria

• No consent to participate in the study or inability to obtain consent
• The inability to insert a urinary catheter
• No indication for urinary catheter
• Patients undergoing palliative treatment
• Patients with advanced liver and kidney disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients for spine surgery in prone position	Intra abdominal pressure measurement	-

Primary Outcome Measures

Name	Time	Method
Increase in intra abdominal pressure during surgery.	Intraoperative	Change in intra abdominal pressure during surgery in prone position.

Secondary Outcome Measures

Name	Time	Method
Correlation of increased abdominal pressure with renal dysfunction assessed by urea.	From start of surgery to eight hours after the surgery.	Assessment of renal function in labolatory tests: urea change (mg/dl).
Correlation of increased abdominal pressure with renal dysfunction assessed by potassium.	From start of surgery to eight hours after the surgery.	Assessment of renal function in labolatory tests: potassium change (mg/dl).
Correlation of increased abdominal pressure with mioglobin.	From start of surgery to eight hours after the surgery.	Assessment in labolatory tests: mioglobin change (mg/dl).
Correlation of increased abdominal pressure with renal dysfunction assessed by creatinine.	From start to eight hours after the surgery.	Assessment of renal function in labolatory tests: creatinine change (mg/dl).

Trial Locations

Locations (1)

Medical University of Warsaw: 1st Department of Anaesthesiology and Intensive Therapy; 🇵🇱 Warsaw, Masovian Voivodeship, Poland