Back to resultsThis Study Performed to Develop a New Technique for Measuring the Intra Abdominal Pressure
Primary Purpose
Abdominal Compartment Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intraocular pressure measurement with 9 mmHg insufflation
Intraocular pressure measurement with 12 mmHg insufflation
Intraocular pressure measurement with 15 mmHg insufflation
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Compartment Syndrome focused on measuring Intra-abdominal pressure,, intraocular pressure,, abdominal hypertension,, laparoscopy,, critical care
Eligibility Criteria
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.
Sites / Locations
- Selcuk University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Group C
Group L
Group M
Group H
Arm Description
The control group (Group C) was not subjected to laparoscopic intervention
Intraocular pressure measurement with 9 mmHg insufflation
Intraocular pressure measurement with 12 mmHg insufflation
Intraocular pressure measurement with 15 mmHg insufflation
Outcomes
Primary Outcome Measures
intra-abdominal pressure
Changes in intraabdominal pressure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02319213
Brief Title
This Study Performed to Develop a New Technique for Measuring the Intra Abdominal Pressure
Official Title
The Increase of Intra-abdominal Pressure Can Affect Intra-ocular Pressure.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the changes of intraocular pressure due to the increase of intra abdominal pressure.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Compartment Syndrome
Keywords
Intra-abdominal pressure,, intraocular pressure,, abdominal hypertension,, laparoscopy,, critical care
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group C
Arm Type
No Intervention
Arm Description
The control group (Group C) was not subjected to laparoscopic intervention
Arm Title
Group L
Arm Type
Experimental
Arm Description
Intraocular pressure measurement with 9 mmHg insufflation
Arm Title
Group M
Arm Type
Experimental
Arm Description
Intraocular pressure measurement with 12 mmHg insufflation
Arm Title
Group H
Arm Type
Experimental
Arm Description
Intraocular pressure measurement with 15 mmHg insufflation
Intervention Type
Other
Intervention Name(s)
Intraocular pressure measurement with 9 mmHg insufflation
Intervention Description
Comparison of intraocular pressure levels at different abdominal pressure
Intervention Type
Other
Intervention Name(s)
Intraocular pressure measurement with 12 mmHg insufflation
Intervention Description
Comparison of intraocular pressure levels at different abdominal pressure
Intervention Type
Other
Intervention Name(s)
Intraocular pressure measurement with 15 mmHg insufflation
Intervention Description
Comparison of intraocular pressure levels at different abdominal pressure
Primary Outcome Measure Information:
Title
intra-abdominal pressure
Description
Changes in intraabdominal pressure
Time Frame
1 day after the surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İlhan Ece
Organizational Affiliation
Selcuk Universitesi Tip Fakultesi Genel Cerrahi poliklinigi
Official's Role
Study Director
Facility Information:
Facility Name
Selcuk University
City
Konya
ZIP/Postal Code
42075
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
25648230
Citation
Ece I, Vatansev C, Kucukkartallar T, Tekin A, Kartal A, Okka M. The increase of intra-abdominal pressure can affect intraocular pressure. Biomed Res Int. 2015;2015:986895. doi: 10.1155/2015/986895. Epub 2015 Jan 14.
Results Reference
derived
Learn more about this trial
This Study Performed to Develop a New Technique for Measuring the Intra Abdominal Pressure
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