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Trial record 15 of 575 for:    CARBON DIOXIDE AND anesthesia

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

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ClinicalTrials.gov Identifier: NCT02036034
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Alvin Tan Siaw Boon, 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.

Condition or disease Intervention/treatment Phase
To Prevent Hypercarbia Under the Opthalmology Drape During Surgery. To Prevent Hypothermia During Opthalmology Surgery. Device: forced air warmer (Bair Hugger) Device: warming blanket Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Modified Ophthalmic Draping Method in Preventing Carbon Dioxide Accumulation in Patient Undergoing Eye Surgery Under Local Anesthesia
Study Start Date : October 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Active Comparator: drape with forced air warmer
forced air warmer placed under the chin before draping, inflated after draping completed.
Device: forced air warmer (Bair Hugger)
forced air warmer placed under the chin before draping, forced air warmer inflated after draping is completed.
Other Name: Forced air warmer brand - Bair Hugger

Placebo Comparator: drape with warming blanket
warming blanket placed on torso of patient under the drape.
Device: warming blanket
warming blanket placed on torso of patient under the drape.
Other Name: warming blanket brand - Thermamed warming system




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036034


Locations
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Malaysia
University Malaya Medical Center
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: Siaw Boon Tan Universiti Malaya
Study Chair: sukhcharanjit S Singh Universiti Malaya

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Responsible Party: Alvin Tan Siaw Boon, Lecturer, University of Malaya
ClinicalTrials.gov Identifier: NCT02036034     History of Changes
Other Study ID Numbers: eyedrapCO2
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: August 2011
Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs