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

NCT ID: NCT02036034

Last Updated: 2014-01-14

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

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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To Prevent Hypercarbia Under the Opthalmology Drape During Surgery. To Prevent Hypothermia During Opthalmology Surgery.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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drape with forced air warmer

forced air warmer placed under the chin before draping, inflated after draping completed.

Group Type ACTIVE_COMPARATOR

forced air warmer (Bair Hugger)

Intervention Type DEVICE

forced air warmer placed under the chin before draping, forced air warmer inflated after draping is completed.

drape with warming blanket

warming blanket placed on torso of patient under the drape.

Group Type PLACEBO_COMPARATOR

warming blanket

Intervention Type DEVICE

warming blanket placed on torso of patient under the drape.

Interventions

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forced air warmer (Bair Hugger)

forced air warmer placed under the chin before draping, forced air warmer inflated after draping is completed.

Intervention Type DEVICE

warming blanket

warming blanket placed on torso of patient under the drape.

Intervention Type DEVICE

Other Intervention Names

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Forced air warmer brand - Bair Hugger warming blanket brand - Thermamed warming system

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Alvin Tan Siaw Boon

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Siaw Boon Tan

Role: PRINCIPAL_INVESTIGATOR

Universiti Malaya

sukhcharanjit S Singh

Role: STUDY_CHAIR

Universiti Malaya

Locations

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University Malaya Medical Center

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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eyedrapCO2

Identifier Type: -

Identifier Source: org_study_id

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