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

To Prevent Hypercarbia Under the Opthalmology Drape During Surgery. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036034
• Other study ID #: eyedrapCO2
• Status: Completed
• Phase: Phase 1
• First received: August 15, 2011
• Last updated: January 11, 2014
• Start date: October 2010
• Est. completion date: January 2012

Study information

• Verified date: August 2011
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: University Malaya
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Device:
• forced air warmer (Bair Hugger)
forced air warmer placed under the chin before draping, forced air warmer inflated after draping is completed.
• warming blanket
warming blanket placed on torso of patient under the drape.

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Center	Kuala Lumpur	Wilayah Persekutuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes, 15 minutes, 30 minutes	Yes