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

NCT ID: NCT02319213

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Abdominal Compartment Syndrome

Keywords

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Intra-abdominal pressure, intraocular pressure, abdominal hypertension, laparoscopy, critical care

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group C

The control group (Group C) was not subjected to laparoscopic intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Group L

Intraocular pressure measurement with 9 mmHg insufflation

Group Type EXPERIMENTAL

Intraocular pressure measurement with 9 mmHg insufflation

Intervention Type OTHER

Comparison of intraocular pressure levels at different abdominal pressure

Group M

Intraocular pressure measurement with 12 mmHg insufflation

Group Type EXPERIMENTAL

Intraocular pressure measurement with 12 mmHg insufflation

Intervention Type OTHER

Comparison of intraocular pressure levels at different abdominal pressure

Group H

Intraocular pressure measurement with 15 mmHg insufflation

Group Type EXPERIMENTAL

Intraocular pressure measurement with 15 mmHg insufflation

Intervention Type OTHER

Comparison of intraocular pressure levels at different abdominal pressure

Interventions

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Intraocular pressure measurement with 9 mmHg insufflation

Comparison of intraocular pressure levels at different abdominal pressure

Intervention Type OTHER

Intraocular pressure measurement with 12 mmHg insufflation

Comparison of intraocular pressure levels at different abdominal pressure

Intervention Type OTHER

Intraocular pressure measurement with 15 mmHg insufflation

Comparison of intraocular pressure levels at different abdominal pressure

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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İlhan Ece

Department of Surgery.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İlhan Ece

Role: STUDY_DIRECTOR

Selcuk Universitesi Tip Fakultesi Genel Cerrahi poliklinigi

Locations

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Selcuk University

Konya, Konya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 25648230 (View on PubMed)

Other Identifiers

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SU 08-38

Identifier Type: -

Identifier Source: org_study_id