Effectiveness of Modified Ophthalmic Draping Method in Preventing Carbon Dioxide Accumulation in Patient Undergoing Eye Surgery Under Local Anesthesia

January 11, 2014 updated by: Alvin Tan Siaw Boon, University of Malaya
The investigators hypothesize that this modified ophthalmic draping will reduce the accumulation and rebreathing of carbon dioxide during eye surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Majority of eye surgery has been widely done under local anesthesia provided by the ophthalmologist with or without sedation.The surgical drapes used often covers the patients face and beyond in order to maintain sterility of the surgical field. This can lead to accumulation of carbon dioxide under ophthalmic drapes due to the exhaled carbon dioxide escapes incompletely through the drapes;hence results in an increase of carbon dioxide in the ambient air surrounding the patient's head.This causes an increase in arterial carbon dioxide partial pressure and thus hyperventilation and patient discomfort with restlessness and unable to stay still during the surgery.

In recent years,several types of ophthalmic drapes have been produced.This study is look for possible difference in accumulation of carbon dioxide under the standard ophthalmic drapes compared to the modified draping.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

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

  • Malaysia
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
        • University Malaya Medical Center

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

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- ASA physical status I,II OR III,adult aged 40 to 80 years old,scheduled to undergo elective eye surgery under local anaesthetic at UMMC will be enrolled in this study.

Exclusion Criteria:

  • Pre-existing pulmonary disease,psychological disorders,neurological disorder and patient required sedation.

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: drape with forced air warmer
forced air warmer placed under the chin before draping, inflated after draping completed.
Device: forced air warmer (Bair Hugger)
forced air warmer placed under the chin before draping, forced air warmer inflated after draping is completed.
Other Names:
  • Forced air warmer brand - Bair Hugger
PLACEBO_COMPARATOR: drape with warming blanket
warming blanket placed on torso of patient under the drape.
Device: warming blanket
warming blanket placed on torso of patient under the drape.
Other Names:
  • warming blanket brand - Thermamed warming system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
transcutaneous CO2 level in mmHg under surgical drape with forced air warmer
Time Frame: 10 minutes, 15 minutes, 30 minutes
baseline transcutanoeus CO2 level will be taken before surgical draping. After draping, CO2 level will be measured with transcutaneous CO2 frome earlobe at 10 minutes, 15 minutes, and 30 minutes.
10 minutes, 15 minutes, 30 minutes

Collaborators and Investigators

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

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Siaw Boon Tan, Universiti Malaya
  • Study Chair: sukhcharanjit S Singh, Universiti Malaya

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

October 1, 2010

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

August 15, 2011

First Submitted That Met QC Criteria

January 11, 2014

First Posted (ESTIMATE)

January 14, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 11, 2014

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eyedrapCO2

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.

Clinical Trials on To Prevent Hypercarbia Under the Opthalmology Drape During Surgery.

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