Clinical trial NCT05626868: Changes of Intra Abdominal Pressure During Surgeries in Prone Position as a Marker of Renal Damage
Official title: Intraoperative Abdominal Pressure Measurement in Patients Undergoing Spine Surgeries in Prone Position as a Marker of Renal Damage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intraabdominal Hypertension
Prone Postion
Spine Surgery
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients qualified for spinal surgery in prone position, who consent to praticipate in the study.

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.


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

Primary outcomes:
measure: Increase in intra abdominal pressure during surgery.
timeFrame: Intraoperative
Secondary outcomes:
measure: Correlation of increased abdominal pressure with renal dysfunction assessed by creatinine.
timeFrame: From start to eight hours after the surgery.
measure: Correlation of increased abdominal pressure with renal dysfunction assessed by urea.
timeFrame: From start of surgery to eight hours after the surgery.
measure: Correlation of increased abdominal pressure with renal dysfunction assessed by potassium.
timeFrame: From start of surgery to eight hours after the surgery.
measure: Correlation of increased abdominal pressure with mioglobin.
timeFrame: From start of surgery to eight hours after the surgery.
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw: 1st Department of Anaesthesiology and Intensive Therapy
state: Masovian Voivodeship
Study officials:
affiliation: Medical Unieveristy of Warsaw
name: Rafał Kowalczyk, MD
role: PRINCIPAL_INVESTIGATOR
References: