Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000328673
Ethics application status
Approved
Date submitted
5/09/2005
Date registered
7/09/2005
Date last updated
7/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Australasian Obstetric General Anaesthesia for Caesarean Section Survey
Scientific title
The Australasian Obstetric General Anaesthesia for Caesarean Section Survey
Universal Trial Number (UTN)
Trial acronym
OBGACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General anaesthesia for caesarean section 416 0
Condition category
Condition code
Anaesthesiology 489 489 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aims of this prospective survey will be to collect contemporary perioperative data in parturients undergoing general anaesthesia for caesarean section in Australasia. The 2 key objectives will be

1. To identify the number of patients identified as difficult to intubate and the approximte incidence of failed intubation in an Australasian population

2. To approximate the incidence of awareness.

Other objectives will be to define patient demographics and details of general anaesthesia for caesarean section in contemporary Australasian practice.
Intervention code [1] 351 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 558 0
To collect a series of data from cases of general anaesthesia for caesarean section reflecting contemporary Australasian practice.
Timepoint [1] 558 0
Data to be collected at the time of operation and at 1 and 4 days postoperatively.
Secondary outcome [1] 1184 0
Difficult intubation as determined by the anaesthetist based on more than one attempt to intubate or immediate decision to use alternative approach to airway based on clinical circumstances.
Timepoint [1] 1184 0
Secondary outcome [2] 1185 0
Failed intubation - the abandonment of intubation as a means of airway management, whether because general anaesthesia is also abandoned or because an alternative approach to airway management is used.
Timepoint [2] 1185 0
Secondary outcome [3] 1186 0
Confirmed aspiration - diagnosis will be based on typical clinical symptoms and signs, with concurrent hypoxaemia, with or without bronchoscopic or CXR changes, and for which other diagnoses have been excluded.
Timepoint [3] 1186 0
Secondary outcome [4] 1187 0
Awareneness - patients will be asked on Day 1 and Day 4 postoperatively whether they have any recall of events or of dreaming between going to sleep and waking up after their operation.
Timepoint [4] 1187 0

Eligibility
Key inclusion criteria
Patients undergoing elective or emergency caesarean section under general anaesthesia between 1.6.05 and 31.5.06.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parturients under 18 years of age.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 553 0
Other Collaborative groups
Name [1] 553 0
ANZCA Research Grant 2006
Country [1] 553 0
Primary sponsor type
Individual
Name
Professor Michael Paech
Address
King Edward Memorial Hospital
374 Bagot Road
Subiaco
Perth WA 6008
Country
Australia
Secondary sponsor category [1] 447 0
Individual
Name [1] 447 0
Dr Karen Scott, Registrar in Anaesthetics
Address [1] 447 0
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
Perth WA 6008
Country [1] 447 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1565 0
King Edward Memorial Hospital for Women
Ethics committee address [1] 1565 0
Ethics committee country [1] 1565 0
Australia
Date submitted for ethics approval [1] 1565 0
Approval date [1] 1565 0
Ethics approval number [1] 1565 0
Ethics committee name [2] 1566 0
Mercy Hospital
Ethics committee address [2] 1566 0
Ethics committee country [2] 1566 0
Australia
Date submitted for ethics approval [2] 1566 0
Approval date [2] 1566 0
Ethics approval number [2] 1566 0
Ethics committee name [3] 1567 0
Royal Women's Hospital
Ethics committee address [3] 1567 0
Ethics committee country [3] 1567 0
Australia
Date submitted for ethics approval [3] 1567 0
Approval date [3] 1567 0
Ethics approval number [3] 1567 0
Ethics committee name [4] 1568 0
Middlemore Hospital
Ethics committee address [4] 1568 0
Ethics committee country [4] 1568 0
New Zealand
Date submitted for ethics approval [4] 1568 0
Approval date [4] 1568 0
Ethics approval number [4] 1568 0
Ethics committee name [5] 1569 0
National Women's Hospital
Ethics committee address [5] 1569 0
Ethics committee country [5] 1569 0
New Zealand
Date submitted for ethics approval [5] 1569 0
Approval date [5] 1569 0
Ethics approval number [5] 1569 0
Ethics committee name [6] 1570 0
Royal North Shore Hospital
Ethics committee address [6] 1570 0
Ethics committee country [6] 1570 0
Australia
Date submitted for ethics approval [6] 1570 0
Approval date [6] 1570 0
Ethics approval number [6] 1570 0
Ethics committee name [7] 1571 0
Royal Women's Hospital
Ethics committee address [7] 1571 0
Ethics committee country [7] 1571 0
Australia
Date submitted for ethics approval [7] 1571 0
Approval date [7] 1571 0
Ethics approval number [7] 1571 0
Ethics committee name [8] 1572 0
Royal Hospital for Women
Ethics committee address [8] 1572 0
Ethics committee country [8] 1572 0
Australia
Date submitted for ethics approval [8] 1572 0
Approval date [8] 1572 0
Ethics approval number [8] 1572 0
Ethics committee name [9] 1573 0
Women and Children's Hospital
Ethics committee address [9] 1573 0
Ethics committee country [9] 1573 0
Australia
Date submitted for ethics approval [9] 1573 0
Approval date [9] 1573 0
Ethics approval number [9] 1573 0
Ethics committee name [10] 1574 0
Wellington Hospital
Ethics committee address [10] 1574 0
Ethics committee country [10] 1574 0
New Zealand
Date submitted for ethics approval [10] 1574 0
Approval date [10] 1574 0
Ethics approval number [10] 1574 0
Ethics committee name [11] 1575 0
Frankston Hospital
Ethics committee address [11] 1575 0
Ethics committee country [11] 1575 0
Australia
Date submitted for ethics approval [11] 1575 0
Approval date [11] 1575 0
Ethics approval number [11] 1575 0
Ethics committee name [12] 1576 0
Gold Coast Hospital
Ethics committee address [12] 1576 0
Ethics committee country [12] 1576 0
Australia
Date submitted for ethics approval [12] 1576 0
Approval date [12] 1576 0
Ethics approval number [12] 1576 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35994 0
Address 35994 0
Country 35994 0
Phone 35994 0
Fax 35994 0
Email 35994 0
Contact person for public queries
Name 9540 0
Professor Michael Paech or Research Nurses, Desiree Cavill & Tracy Bingham
Address 9540 0
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco Perth WA 6008
Country 9540 0
Australia
Phone 9540 0
+61 8 93402222 Pager 3223 (Mike Paech) or 3433 (Research Nurses)
Fax 9540 0
+61 8 93402260
Email 9540 0
[email protected]
Contact person for scientific queries
Name 468 0
Professor Michael Paech
Address 468 0
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco Perth WA 6008
Country 468 0
Australia
Phone 468 0
+61 8 93402222 Pager 3223
Fax 468 0
+61 8 93402260
Email 468 0
[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

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