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

Intraoperative Abdominal Pressure Measurement in Patients Undergoing Spine Surgeries in Prone Position as a Marker of Renal Damage

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.

Study Overview

• Status: Recruiting
• Conditions: Spine Surgery; Intraabdominal Hypertension; Prone Postion
• Intervention / Treatment: Device: Intra abdominal pressure measurement

• Study Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

• Study Contact: Name: Bartosz Stangiewicz, MD; Phone Number: +48605941973; Email: bartosz.stangiewicz@wum.edu.pl

Study Locations

• Poland
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-005
      • Recruiting
      • Medical University of Warsaw: 1st Department of Anaesthesiology and Intensive Therapy
      • Contact: Rafał Kowałczyk, MD; Phone Number: +48 22 5021685; Email: rafal.kowalczyk@wum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients qualified for spinal surgery in prone position, who consent to praticipate in the study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients for spine surgery in prone position	Device: Intra abdominal pressure measurement; Device: Biometrix - Intraabdominal pressure monitoring set Intraabdominal pressure monitoring with the intended set in values of milimeters of mercury (mmHg) in real time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in intra abdominal pressure during surgery.	Change in intra abdominal pressure during surgery in prone position.	Intraoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Rafał Kowalczyk, MD, Medical Unieveristy of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Actual): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes; Intra-Abdominal Hypertension
• Other Study ID Numbers: MG/M/37/37/20(1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No