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Trial registered on ANZCTR


Registration number
ACTRN12609000297224
Ethics application status
Approved
Date submitted
12/03/2009
Date registered
18/05/2009
Date last updated
9/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Does prewarming children improve outcomes in children with cerebral palsy having major lower limb surgery?
Scientific title
A randomised study assessing the effect of prewarming on outcomes of children with cerebral palsy undergoing orthopaedic surgery to prevent hypothermia
Secondary ID [1] 284143 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children with severe cerebral palsy undergoing elective bilateral femoral valgus derotational osteotomies 4466 0
Condition category
Condition code
Anaesthesiology 4736 4736 0 0
Other anaesthesiology
Surgery 4739 4739 0 0
Other surgery
Neurological 237150 237150 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is for patients to lie in a bed and be prewarmed with a forced air warming blanket set at 40 degrees for one hour prior to induction of anaesthesia.
Intervention code [1] 4211 0
Treatment: Other
Comparator / control treatment
The control group will receive routine care (ie: no prewarming). The control group are not required to lie on a theatre trolley for an hour prior to their surgery and will simply wait for their operation as they would for usual surgery.
Control group
Active

Outcomes
Primary outcome [1] 5604 0
To determine whether prewarming can prevent hypothermia. Skin temperature and core temperature (tympanic) will be measured pre and post anaesthesia. During anaesthesia, temperature will be measured using an oesophageal temperature probe.
Timepoint [1] 5604 0
Temperature will measured pre-operatively, intra-operatively and post-operatively every 30 minutes until discharge from the post-anaesthesia care unit (PACU).
Secondary outcome [1] 9431 0
To determine whether prewarming effects the duration of recovery from anaesthesia.
Timepoint [1] 9431 0
Time spent in the post anaesthesia care unit (from arrival until discharge).
Secondary outcome [2] 9432 0
To determine whether prewarming effects the amount of surgical blood loss. To assess intraoperative and postoperative blood loss we will use (a) Weighing packs, (b) Measuring Drains and (c) Haemoglobin Balance method.
Timepoint [2] 9432 0
Blood loss measured intraoperatively and postoperatively. These measurements will take place at frequent intervals within these periods.
Secondary outcome [3] 9433 0
To determine whether effects the rate of wound infections. Wounds will be classified as infected if there was a purulent discharge or painful erythema that lasted for 5 days and was treated with antibiotics within 6 weeks of surgery.
Timepoint [3] 9433 0
Postoperative wound infection will be assessed during their inpatient stay and also in their scheduled outpatient visits at 3 and 6 weeks post discharge.

Eligibility
Key inclusion criteria
1)Children with severe cerebral palsy undergoing elective bilateral femoral valgus derotational osteotomies
2) Children aged between 5 -20 years
3) Any weight
Minimum age
5 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Any contraindication to inhaled anaesthetic agents (desflurane/nitrous oxide) (eg: malignant hyperthermia)
2) Severe comorbidities that require postoperative admission to intensive care.
3) Contraindications to epidural anaesthesia
(eg: iatrogenic or pathological coagulopathy or platelet dysfunction, local Sepsis, parental refusal to consent)
3) Ambient room temperature > 28 degrees in the pre-surgical centre

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be identified from the orthopaedic booking list. Patients routinely attend the hospital in the week(s) prior to their surgery. At this point, they will be assessed for inclusion in the study. If they are eligible and the parents provide informed consent, they will be randomised into the study. The allocation concealment was carried out using sealed opaque envelopes. The study will be single blinded (the patient and parent will be aware which treatment group they are allocated to, the anaesthetist will be aware, the surgeon will be blinded, the recovery nurse assessing readiness for discharge will be blinded).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will undergo computer generated block randomisation into two groups: prewarmed versus routine care. Blocks will not be of fixed length.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
30/03/2009
Actual
10/02/2010
Date of last participant enrolment
Anticipated
Actual
22/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4657 0
Hospital
Name [1] 4657 0
Royal Children's Hospital
Country [1] 4657 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
Flemington Road,
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 4204 0
None
Name [1] 4204 0
Address [1] 4204 0
Country [1] 4204 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6693 0
Royal Children's Hospital Research Ethics Committee
Ethics committee address [1] 6693 0
Royal Children's Hospital
Flemington Road,
Parkville
VIC 3052
Ethics committee country [1] 6693 0
Australia
Date submitted for ethics approval [1] 6693 0
Approval date [1] 6693 0
24/07/2008
Ethics approval number [1] 6693 0
27157

Summary
Brief summary
This is a controlled single-blind randomised study assessing the effect of prewarming on outcomes of patients with severe cerebral palsy undergoing major orthopaedic surgery.
The study objectives are to assess the effect of prewarming participants prior to anaesthesia with regard to:
i) Avoiding hypothermia.
ii) Duration of recovery from anaesthesia.
iii) Amount of surgical blood loss.
iv) Rate of wound infections.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29388 0
Dr Ben Hallett
Address 29388 0
Department of Anaesthesia & Pain Management
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country 29388 0
Australia
Phone 29388 0
+61393455233
Fax 29388 0
+61393456003
Email 29388 0
[email protected]
Contact person for public queries
Name 12635 0
Suzette Sheppard
Address 12635 0
Department of Anaesthesia
Royal Children's Hospital
Flemington Road,
Parkville
VIC 3052
Country 12635 0
Australia
Phone 12635 0
+61 3 9345 5233
Fax 12635 0
+61 3 9345 6003
Email 12635 0
[email protected]
Contact person for scientific queries
Name 3563 0
Dr Ben Hallett
Address 3563 0
Department of Anaesthesia
Royal Children's Hospital
Flemington Road,
Parkville
VIC 3052
Country 3563 0
Australia
Phone 3563 0
+61 3 9345 5233
Fax 3563 0
+61 3 9345 6003
Email 3563 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

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

Documents added automatically
No additional documents have been identified.