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OpenTrials
Completed

NCT Number: NCT02036034

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

The investigators hypothesize that this modified ophthalmic draping will reduce the accumulation and rebreathing of carbon dioxide during eye surgery.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

forced air warmer (Bair Hugger)

Device

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

warming blanket

Device

warming blanket placed on torso of patient under the drape.

Other names: warming blanket brand - Thermamed warming system

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jan 14, 2014
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.