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

Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05626868
• Other study ID #: MG/M/37/37/20(1)
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Medical University of Warsaw
• Contact: Bartosz Stangiewicz, MD
• Phone: +48605941973
• Email: bartosz.stangiewicz[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intra-Abdominal Hypertension
• Intraabdominal Hypertension
• Spine Surgery

Intervention

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.

Locations

Country	Name	City	State
Poland	Medical University of Warsaw: 1st Department of Anaesthesiology and Intensive Therapy	Warsaw	Masovian Voivodeship

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in intra abdominal pressure during surgery.	Change in intra abdominal pressure during surgery in prone position.	Intraoperative
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.