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

Phase 1

Completed

• Conditions: To Prevent Hypercarbia Under the Opthalmology Drape During Surgery.; To Prevent Hypothermia During Opthalmology Surgery.
• Interventions: Device: forced air warmer (Bair Hugger); Device: warming blanket

• Registration Number: NCT02036034
• Lead Sponsor: University of Malaya

Brief Summary

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

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 Timeline

• Study Start: 2010-10
• Status Verified: 2011-08
• Study First Submitted: 2011-08-15
• Primary Completion: 2011-11
• Study Completion: 2012-01
• Study First Submitted QC: 2014-01-11
• Last Update Submitted: 2014-01-11
• Study First Posted: 2014-01-14
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drape with forced air warmer	forced air warmer (Bair Hugger)	forced air warmer placed under the chin before draping, inflated after draping completed.
drape with warming blanket	warming blanket	warming blanket placed on torso of patient under the drape.

Primary Outcome Measures

Name	Time	Method
transcutaneous CO2 level in mmHg under surgical drape with forced air warmer	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.

Trial Locations

Locations (1)

University Malaya Medical Center; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia