NCT02319213

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

10 months

First QC Date

December 7, 2014

Last Update Submit

December 17, 2014

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • intra-abdominal pressure

    Changes in intraabdominal pressure

    1 day after the surgery.

Study Arms (4)

Group C

NO INTERVENTION

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

Group L

EXPERIMENTAL

Intraocular pressure measurement with 9 mmHg insufflation

Other: Intraocular pressure measurement with 9 mmHg insufflation

Group M

EXPERIMENTAL

Intraocular pressure measurement with 12 mmHg insufflation

Other: Intraocular pressure measurement with 12 mmHg insufflation

Group H

EXPERIMENTAL

Intraocular pressure measurement with 15 mmHg insufflation

Other: Intraocular pressure measurement with 15 mmHg insufflation

Interventions

Comparison of intraocular pressure levels at different abdominal pressure

Group L

Comparison of intraocular pressure levels at different abdominal pressure

Group M

Comparison of intraocular pressure levels at different abdominal pressure

Group H

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) of 30 kg/m2 or less
  • American Society of Anesthesiologists (ASA) status I-II

You may not qualify if:

  • Pre-existing eye disease,
  • Cardiovascular or neuromuscular disease,
  • Difficult intubation,
  • The use of any antihypertensive agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, Konya, 42075, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Interventions

Intraocular Pressure

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Study Officials

  • İlhan Ece

    Selcuk Universitesi Tip Fakultesi Genel Cerrahi poliklinigi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Surgery.

Study Record Dates

First Submitted

December 7, 2014

First Posted

December 18, 2014

Study Start

March 1, 2008

Primary Completion

January 1, 2009

Study Completion

November 1, 2009

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations