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

NCT05626868 | Unknown

• 1 other identifier: MG/M/37/37/20(1)
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraabdominal Hypertension; Prone Postion; Spine Surgery

Outcome Measures

Primary Outcomes (1)

• Increase in intra abdominal pressure during surgery.

  Change in intra abdominal pressure during surgery in prone position.

  Intraoperative

Secondary Outcomes (4)

• Correlation of increased abdominal pressure with renal dysfunction assessed by creatinine.

  From start to eight hours after the surgery.

• Correlation of increased abdominal pressure with renal dysfunction assessed by urea.

  From start of surgery to eight hours after the surgery.

• Correlation of increased abdominal pressure with renal dysfunction assessed by potassium.

  From start of surgery to eight hours after the surgery.

• Correlation of increased abdominal pressure with mioglobin.

  From start of surgery to eight hours after the surgery.

Study Arms (1)

Patients for spine surgery in prone position

Device: Intra abdominal pressure measurement

Interventions

Intra abdominal pressure measurement DEVICE

Device: Biometrix - Intraabdominal pressure monitoring set Intraabdominal pressure monitoring with the intended set in values of milimeters of mercury (mmHg) in real time.

Patients for spine surgery in prone position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw: 1st Department of Anaesthesiology and Intensive Therapy

Warsaw, Masovian Voivodeship, 02-005, Poland

RECRUITING

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rafał Kowalczyk, MD

  Medical Unieveristy of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bartosz Stangiewicz, MD

CONTACT

+48605941973; bartosz.stangiewicz@wum.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 25, 2022
• Study Start: May 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)