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

NCT ID: NCT05626868

Last Updated: 2022-11-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients for spine surgery in prone position

Intra abdominal pressure measurement

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafał Kowalczyk, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Unieveristy of Warsaw

Locations

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

Warsaw, Masovian Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Bartosz Stangiewicz, MD

Role: CONTACT

bartosz.stangiewicz@wum.edu.pl

+48605941973

Facility Contacts

Rafał Kowałczyk, MD

Role: primary

rafal.kowalczyk@wum.edu.pl

+48 22 5021685

Other Identifiers

MG/M/37/37/20(1)

Identifier Type: -

Identifier Source: org_study_id