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

Primary Purpose

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

Status

Completed

Phase

Phase 1

Locations

Malaysia

Study Type

Interventional

Intervention

forced air warmer (Bair Hugger)

warming blanket

About this trial

This is an interventional prevention trial for To Prevent Hypercarbia Under the Opthalmology Drape During Surgery.

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Malaya Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

drape with forced air warmer

drape with warming blanket

Arm Description

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

warming blanket placed on torso of patient under the drape.

Outcomes

Primary Outcome Measures

transcutaneous CO2 level in mmHg under surgical drape with forced air warmer

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02036034

First Posted

August 15, 2011

Last Updated

January 11, 2014

Sponsor

University of Malaya

1. Study Identification

Unique Protocol Identification Number

NCT02036034

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Malaya

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

drape with forced air warmer

Arm Type

Active Comparator

Arm Description

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

Arm Title

drape with warming blanket

Arm Type

Placebo Comparator

Arm Description

warming blanket placed on torso of patient under the drape.

Intervention Type

Device

Intervention Name(s)

forced air warmer (Bair Hugger)

Other Intervention Name(s)

Forced air warmer brand - Bair Hugger

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

warming blanket

Other Intervention Name(s)

warming blanket brand - Thermamed warming system

Intervention Description

warming blanket placed on torso of patient under the drape.

Primary Outcome Measure Information:

Title

transcutaneous CO2 level in mmHg under surgical drape with forced air warmer

Description

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.

Time Frame

10 minutes, 15 minutes, 30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Siaw Boon Tan

Organizational Affiliation

Universiti Malaya

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

sukhcharanjit S Singh

Organizational Affiliation

Universiti Malaya

Official's Role

Study Chair

Facility Information:

Facility Name

University Malaya Medical Center

City

Kuala Lumpur

State/Province

Wilayah Persekutuan

ZIP/Postal Code

59100

Country

Malaysia

12. IPD Sharing Statement

Learn more about this trial

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

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