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

December 17, 2014 updated by: İlhan Ece, Selcuk University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42075
        • Selcuk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group C
The control group (Group C) was not subjected to laparoscopic intervention
Experimental: Group L
Intraocular pressure measurement with 9 mmHg insufflation
Other: Intraocular pressure measurement with 9 mmHg insufflation
Comparison of intraocular pressure levels at different abdominal pressure
Experimental: Group M
Intraocular pressure measurement with 12 mmHg insufflation
Other: Intraocular pressure measurement with 12 mmHg insufflation
Comparison of intraocular pressure levels at different abdominal pressure
Experimental: Group H
Intraocular pressure measurement with 15 mmHg insufflation
Other: Intraocular pressure measurement with 15 mmHg insufflation
Comparison of intraocular pressure levels at different abdominal pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intra-abdominal pressure
Time Frame: 1 day after the surgery.
Changes in intraabdominal pressure
1 day after the surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selcuk University

Investigators

  • Study Director: İlhan Ece, Selcuk Universitesi Tip Fakultesi Genel Cerrahi poliklinigi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 7, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (Estimate)

December 18, 2014

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU 08-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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