NCT02036034

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
Last Updated

January 14, 2014

Status Verified

August 1, 2011

Enrollment Period

1.1 years

First QC Date

August 15, 2011

Last Update Submit

January 11, 2014

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

drape with forced air warmer

ACTIVE COMPARATOR

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

Device: forced air warmer (Bair Hugger)

drape with warming blanket

PLACEBO COMPARATOR

warming blanket placed on torso of patient under the drape.

Device: warming blanket

Interventions

forced air warmer (Bair Hugger)DEVICE

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

Also known as: Forced air warmer brand - Bair Hugger
drape with forced air warmer
warming blanketDEVICE

warming blanket placed on torso of patient under the drape.

Also known as: warming blanket brand - Thermamed warming system
drape with warming blanket

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • Pre-existing pulmonary disease,psychological disorders,neurological disorder and patient required sedation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Center

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Study Officials

  • Siaw Boon Tan

    Universiti Malaya

    PRINCIPAL INVESTIGATOR

  • sukhcharanjit S Singh

    Universiti Malaya

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 15, 2011

First Posted

January 14, 2014

Study Start

October 1, 2010

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

January 14, 2014

Record last verified: 2011-08

Locations

MY(1)