Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000237088
Ethics application status
Approved
Date submitted
12/03/2010
Date registered
22/03/2010
Date last updated
4/02/2020
Date data sharing statement initially provided
4/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Incidence of Respiratory Complications and Nausea and Vomiting following repositioning of fractures in dependence of the time of accident and the time of surgery
Scientific title
Incidence of Respiratory Complications and Nausea and Vomiting following repositioning of fractures in dependence of the time of accident and the time of surgery
Secondary ID [1] 1521 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incidence of Respiratory Complications and Nausea and Vomiting following repositioning of fractures 256962 0
Condition category
Condition code
Anaesthesiology 257105 257105 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Incidence of respiratory complications, nausea and vomiting following repositioning of fractures in dependence of the time of accident and the time of surgery
Complications and their incidence will be monitored by clinical examination.
Recruitment over a period of 12 months.
Intervention code [1] 256139 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258000 0
Incidence of Respiratory Complications following repositioning of fractures in dependence of the time of accident and the time of surgery
Assessment by clinical monitoring.
Timepoint [1] 258000 0
Intraoperatively and immediate recovery period until discharge
Secondary outcome [1] 263554 0
Incidence of postoperative nausea and vomiting and pain following repositioning of fractures in dependence of the time of accident and the time of surgery
Assessment by clinical monitoring.
Timepoint [1] 263554 0
Intraoperatively and immediate recovery period until discharge

Eligibility
Key inclusion criteria
patients undergoing repositioning of fractures of the arm, wrist or lower leg
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.
There are no exclusion criteria: all patients undergoing repositioning of fractures of the arm, wrist or lower leg will be audited.

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
15/03/2010
Actual
26/02/2010
Date of last participant enrolment
Anticipated
Actual
17/02/2011
Date of last data collection
Anticipated
Actual
31/03/2011
Sample size
Target
400
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 15769 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 29202 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 256642 0
Hospital
Name [1] 256642 0
Princess Margaret Hospital for Children
Country [1] 256642 0
Australia
Primary sponsor type
Individual
Name
Britta Regli-von Ungern
Address
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country
Australia
Secondary sponsor category [1] 255929 0
Individual
Name [1] 255929 0
Neil Chambers
Address [1] 255929 0
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country [1] 255929 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305263 0
Hospital Quality Improvement Committee
Ethics committee address [1] 305263 0
Princess Margaret Hospital
Roberts Road
Subiaco
Western Australia
6008
Ethics committee country [1] 305263 0
Australia
Date submitted for ethics approval [1] 305263 0
03/02/2010
Approval date [1] 305263 0
26/02/2010
Ethics approval number [1] 305263 0
2042 - 02/10

Summary
Brief summary
The purpose of this audit is to assess the incidence of nausea, vomiting and pain in children undergoing repositioning of their fractures arm/arms, lower legs in the immediate postoperative period before discharge home.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30928 0
Prof Britta von Ungern-Sternberg
Address 30928 0
Department of Anaesthesia and Pain Management
Perth Children's Hospital
15 Hospital Avenue
Nedlands
6009
WA
Country 30928 0
Australia
Phone 30928 0
+61864564805
Fax 30928 0
Email 30928 0
[email protected]
Contact person for public queries
Name 14175 0
Britta Regli-von Ungern
Address 14175 0
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country 14175 0
Australia
Phone 14175 0
+61893408222
Fax 14175 0
Email 14175 0
[email protected]
Contact person for scientific queries
Name 5103 0
Britta Regli-von Ungern
Address 5103 0
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country 5103 0
Australia
Phone 5103 0
+61893408222
Fax 5103 0
Email 5103 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.