Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001161910
Ethics application status
Approved
Date submitted
4/11/2011
Date registered
7/11/2011
Date last updated
7/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Eye surgery under regional anaesthesia - what's going on beneath the drapes?
Scientific title
Novel oxygen delivery system to elective opthalmic surgery patients comparing inspired oxygen & carbon dioxide and end-tidal carbon dioxide levels under the surgical drapes & their effect on patient's vital signs.
Secondary ID [1] 273330 0
Nil
Universal Trial Number (UTN)
U1111-1125-6592
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Level of inspired oxygen under drapes used for elective opthalmic surgical procedures. 279099 0
Level of inspired carbon dioxide under drapes used for elective opthalmic surgical procedures. 279103 0
Level of end-tidal carbon dioxide under drapes used for elective opthalmic surgical procedures. 279104 0
Condition category
Condition code
Anaesthesiology 279290 279290 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational pilot study.

Patients undergoing elective ophthalmic operations under regional anaesthesia were enrolled in this study after informed consent.

Standard, waterproof ophthalmic drapes were used to cover the patients during the procedure and oxygen was administered via a modified plastic canister at a flow rate of 6L/min.

In this study we characterise this elderly population and show patients are exposed to an increased FiO2, FiCO2 and EtCO2 as the operation progressed without adverse events.

The overall duration of the study was 3 months.
Intervention code [1] 283677 0
Not applicable
Comparator / control treatment
This current observational pilot study referred to looks at the oxygen delivery system used at our institution.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279906 0
Primary outcome: Inspired oxygen (FiO2) level under surgical drapes.
Assessed with gas monitoring line under surgical drape.
Timepoint [1] 279906 0
Time interval: at 5-10 min intervals until cessation of surgical procedure.
Primary outcome [2] 279915 0
Primary outcome: Inspired & End-tidal carbon dioxide level under surgical drapes.
Assessed with gas monitoring line under surgical drape.
Timepoint [2] 279915 0
Time interval: at 5-10 min intervals until cessation of surgical procedure.
Primary outcome [3] 279916 0
Primary outcome: Inspired and end-tidal carbon dioxide level under surgical drapes.
Assessed with gas monitoring line under surgical drape.
Timepoint [3] 279916 0
Time interval: at 5-10 min intervals until cessation of surgical procedure.
Secondary outcome [1] 294745 0
Secondary outcome: Patient's oxygen saturation (SaO2) and mean arterial blood pressure (MAP)
Assessed with pulse oximeter.
Timepoint [1] 294745 0
Time interval: at 5-10 min intervals until cessation of surgical procedure
Secondary outcome [2] 294771 0
Secondary outcome: Patient's heart & respiratory rate (HR & RR).
Assessed with ECG monitor and clinical assessment.
Timepoint [2] 294771 0
Time interval: at 5-10 min intervals until cessation of surgical procedure

Eligibility
Key inclusion criteria
Patients were included in the study if they were undergoing ophthalmic surgery under regional or topical anaesthesia, over 18 and able to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None elective opthalmic surgery
No informed consent
General anaesthesia
Contra-indication to regional opthalmic anaesthesia
Inability to lie flat & still for operation duration
Under 18 years

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284158 0
Hospital
Name [1] 284158 0
Department of Anaesthesia, Fremantle Hospital, WA
Country [1] 284158 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia, Fremantle Hospital, WA
Address
Fremantle Hospital
Alma Street
Fremantle
WA 6160
Country
Australia
Secondary sponsor category [1] 269116 0
None
Name [1] 269116 0
Address [1] 269116 0
Country [1] 269116 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272120 0
South Metropolitan Area Health Service
Ethics committee address [1] 272120 0
Fremantle Hospital
Alma Street
Fremantle
WA 6160
Ethics committee country [1] 272120 0
Australia
Date submitted for ethics approval [1] 272120 0
01/05/2010
Approval date [1] 272120 0
01/06/2010
Ethics approval number [1] 272120 0

Summary
Brief summary
Thirty four patients undergoing elective ophthalmic operations under regional anaesthesia were enrolled in this study after informed consent. Standard, waterproof ophthalmic drapes were used to cover the patients during the procedure and oxygen was administered via a modified plastic canister at a flow rate of 6L/min. In this study we characterise this elderly population and show patients are exposed to an increased inspired oxygen (FiO2), inspired carbon dioxide (FiCO2) and end-tidal carbon dioxide (EtCO2) level. The operation progressed without adverse events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33353 0
Address 33353 0
Country 33353 0
Phone 33353 0
Fax 33353 0
Email 33353 0
Contact person for public queries
Name 16600 0
Dr Laura Tarry
Address 16600 0
Department of Anaesthesia
Fremantle Hospital
Alma Street
Fremantle
WA 6160
Country 16600 0
Australia
Phone 16600 0
+61894312551
Fax 16600 0
Email 16600 0
[email protected]
Contact person for scientific queries
Name 7528 0
Dr Edmond O'Loughlin
Address 7528 0
Department of Anaesthesia
Fremantle Hospital
Alma Street
Fremantle
WA 6160
Country 7528 0
Australia
Phone 7528 0
+61894312551
Fax 7528 0
Email 7528 0
Edmond.O'[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.