This Study Performed to Develop a New Technique for Measuring the Intra Abdominal Pressure

Abdominal Compartment Syndrome Clinical Trial

Official title:

The Increase of Intra-abdominal Pressure Can Affect Intra-ocular Pressure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319213
• Other study ID #: SU 08-38
• Status: Completed
• Phase: N/A
• First received: December 7, 2014
• Last updated: December 17, 2014
• Start date: March 2008
• Est. completion date: November 2009

Study information

• Verified date: December 2014
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the changes of intraocular pressure due to the increase of intra abdominal pressure.

Description:

In this prospective study, 40 patients undergoing elective surgery were included. Patients were divided into four groups of 10 patients. The control group (Group C) was not subjected to laparoscopic intervention. Laparoscopic surgery was respectively performed with an intra-abdominal pressure of 9, 12 and 15 mmHg in Groups L (low), M (medium), and H (high pressure). Intraocular pressure was measured binocularly in each patient at three different time (before, during and end of surgery) using a contact tonometer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) of 30 kg/m2 or less

• American Society of Anesthesiologists (ASA) status I-II

Exclusion Criteria:

• Pre-existing eye disease,

• Cardiovascular or neuromuscular disease,

• Difficult intubation,

• The use of any antihypertensive agents.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abdominal Compartment Syndrome
• Compartment Syndromes
• Intra-Abdominal Hypertension

Intervention

Other:
• Intraocular pressure measurement with 9 mmHg insufflation
Comparison of intraocular pressure levels at different abdominal pressure
• Intraocular pressure measurement with 12 mmHg insufflation
Comparison of intraocular pressure levels at different abdominal pressure
• Intraocular pressure measurement with 15 mmHg insufflation
Comparison of intraocular pressure levels at different abdominal pressure

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intra-abdominal pressure	Changes in intraabdominal pressure	1 day after the surgery.	Yes