To Prevent Hypercarbia Under the Opthalmology Drape During Surgery.Phase 1NCT02036034
Effectiveness of Modified Ophthalmic Draping Method in Preventing Carbon Dioxide Accumulation in Patient Undergoing Eye Surgery Under Local Anesthesia
A Phase 1 study testing forced air warmer (Bair Hugger) and warming blanket in people with To Prevent Hypercarbia Under the Opthalmology Drape During Surgery. and To Prevent Hypothermia During Opthalmology Surgery., run by University of Malaya at 1 site in Malaysia.
Trial summary
The investigators hypothesize that this modified ophthalmic draping will reduce the accumulation and rebreathing of carbon dioxide during eye surgery. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- To Prevent Hypercarbia Under the Opthalmology Drape During Surgery., To Prevent Hypothermia During Opthalmology Surgery.
- What is being tested?
- forced air warmer (Bair Hugger) and warming blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2010to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pre-existing pulmonary disease,psychological disorders,neurological disorder and patient required sedation.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Center
Kuala Lumpur, Kuala Lumpur, 59100
About this study
The investigators hypothesize that this modified ophthalmic draping will reduce the accumulation and rebreathing of carbon dioxide during eye surgery.
Read the 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.
- Conditions
- To Prevent Hypercarbia Under the Opthalmology Drape During Surgery., To Prevent Hypothermia During Opthalmology Surgery.
- Being tested
- forced air warmer (Bair Hugger), warming blanket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
forced air warmer (Bair Hugger)Device
Also called Forced air warmer brand - Bair Hugger
forced air warmer placed under the chin before draping, forced air warmer inflated after draping is completed.
warming blanketDevice
Also called warming blanket brand - Thermamed warming system
warming blanket placed on torso of patient under the drape.
| Study group | Role | What they receive |
|---|---|---|
| drape with forced air warmer | Active comparator | forced air warmer placed under the chin before draping, inflated after draping completed. Receives: Device: forced air warmer (Bair Hugger) |
| drape with warming blanket | Placebo comparator | warming blanket placed on torso of patient under the drape. Receives: Device: warming blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes, 15 minutes, 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startOct 2010
- Primary completionNov 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Prevent Hypercarbia Under the Opthalmology Drape During Surgery.Studies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvin Tan Siaw Boon, University of Malaya
- Investigators
- Siaw Boon Tan, Principal investigator, University of Malayasukhcharanjit S Singh, Study chair, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036034
- Sponsor's protocol ID
- eyedrapCO2
- Status last verified
- Aug 2011
- First submitted
- 15 Aug 2011
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Modified Ophthalmic Draping Method in Preventing Carbon Dioxide Accumulation in Patient Undergoing Eye Surgery Under Local Anesthesia
- ClinicalTrials.gov ID
- NCT02036034
- Acronym / sponsor ID
- eyedrapCO2
- Conditions
- To Prevent Hypercarbia Under the Opthalmology Drape During Surgery., To Prevent Hypothermia During Opthalmology Surgery.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drape with forced air warmer | Active comparator | Device: forced air warmer (Bair Hugger)forced air warmer placed under the chin before draping, inflated after draping completed. |
| drape with warming blanket | Placebo comparator | Device: warming blanketwarming blanket placed on torso of patient under the drape. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Pre-existing pulmonary disease,psychological disorders,neurological disorder and patient required sedation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| forced air warmer (Bair Hugger)Also: Forced air warmer brand - Bair Huggerforced air warmer placed under the chin before draping, forced air warmer inflated after draping is completed. | Device | drape with forced air warmer |
| warming blanketAlso: warming blanket brand - Thermamed warming systemwarming blanket placed on torso of patient under the drape. | Device | drape with warming blanket |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siaw Boon Tan principal investigator
University of Malaya
sukhcharanjit S Singh study chair
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing forced air warmer (Bair Hugger) and warming blanket in people with To Prevent Hypercarbia Under the Opthalmology Drape During Surgery. and To Prevent Hypothermia During Opthalmology Surgery., run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transcutaneous CO2 level in mmHg under surgical drape with forced air warmer (time frame: 10 minutes, 15 minutes, 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.