Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000931673
Ethics application status
Approved
Date submitted
23/08/2014
Date registered
29/08/2014
Date last updated
29/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
'Keeping them Warm' - A randomised controlled trial of two passive perioperative warming methods
Scientific title
A prospective randomised controlled trial to determine if thermal insulation with reflective blankets is more effective than cotton blankets in reducing the temperature gradient from the body's periphery to the core during the preoperative phase in adult patients undergoing short surgery and thus reducing the intraoperative drop in core temperature.
Secondary ID [1] 285210 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inadvertent Perioperative Hypothermia 292828 0
Condition category
Condition code
Anaesthesiology 293127 293127 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are randomised into two groups:
1. the reflective blanket group will receive a reflective blanket (MEDIflex, desposable emergency blanket, 140x210cm) close to the skin and one cotton sheet on top to contain the light weight reflective blanket.
2. patients allocated to the cotton will receive a cotton sheet to the skin and a cotton blanket on top of the sheet.

In both groups the blankets will be tucked around the patient, leaving only the head and at times their arms exposed, for the preoperative period from admission to the anaesthetic bay until discharge from the Post- anaesthesia recovery unit (PARU).
Intervention code [1] 290084 0
Prevention
Comparator / control treatment
Patients in the control group receive a cotton sheet to the skin and a cotton blanket on top of the sheet
Control group
Active

Outcomes
Primary outcome [1] 292990 0
The difference between the foot and the temporal artery temperatures in the admitting ward and anaesthetic bay in the two groups.
Timepoint [1] 292990 0
Temperatures will be measured on either the right or left temporal artery and the right or left sole of the foot on admission and in the anesthetic bay before leaving into the operating room.
Time will be recorded between the two measurements with a timer.
Temperatures will be measured with a non-contact infrared digital thermometer.
Primary outcome [2] 292991 0
The preoperative change in foot temperature between the admitting ward and the anaesthetic bay in the two groups.
Timepoint [2] 292991 0
Temperatures are taken on admission and in the anaesthetic bay befor entering the operating room with a non-contact infrared digital thermometer.
Primary outcome [3] 292992 0
The average difference in temperature will be calculated for each group (reflective vs. cotton blankets). Temperatures will be measured on either the right or left temporal artery and the right or left some of the foot with a non-contact infrared digital thermometer.
Timepoint [3] 292992 0
Independent sample t-test will be used to compare average difference in temporal artery and foot temperature for each group from admission to anaesthetic bay.
Secondary outcome [1] 310092 0
The 15 minute time interval at which the lowest intra-operative decrease in temperature will occour.
Timepoint [1] 310092 0
From start of operation every 15 minutes up to 60 minutes with non-contact infrared digital thermometer.
Secondary outcome [2] 310093 0
The proportion of people who arrive normothermic in recovery for each group.
Timepoint [2] 310093 0
Temporal artery temperatures are measured within 5 minutes of arrival to recovery with a non-contact infrared digital thermometer.
Secondary outcome [3] 310094 0
The proportion of patients who request additional warmed blankets.
Timepoint [3] 310094 0
during any time of the perioperative journey

Eligibility
Key inclusion criteria
- adult patients 18 years and over who undergo elective surgery where the estimated time of surgery is less tha one hour;
- American Society of Anesthesiologists (ASA) classification 3 and under;
- general anaesthesia or combined general/regional
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- ASA 4 and over;
- surgery predicted longer than one hour;
- predicted local/regional anaesthesia or sedation;
- patients who do not consent for their data to be collected to be used for research purposes;
- patients whose surgery will be cancelled or postponed;
- when nurses are not able to consent patients due to workload
- surgery to the head, nose and throat

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The lead researcher will prepare sequentially numbered, opaque envelopes, enclose the particular intervention sheet for group 1 or 2 to the assigned corresponding number as per randomisation schedule and seal the envelops. The admitting nurse will assign the envelopes in numerical sequence to the patients as they consent to partake in the study. The nurse will be unaware towards the intervention concealed in the envelope to prevent selection bias. The envelope will only be opened by the perioperative nurse preparing the patient for surgery.

The project manager will review the operation schedule the day prior and identify subjects who meet the inclusion criteria for the study. To confirm ASA patient medical records will be consulted.

A list with names of the eligible patients will be generated for the admission nurse for recruitment.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A biostatistician, with no clinical involvement in the trial, will create a computer generated randomization sequence using a Microsoft Excel spread sheet random number generator. Space blankets are allocated numbers between 0 – 0.5 and cotton blanket above 0.5 – 1. Consecutive number from 1 - 328 will be assigned to each intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculation for the study is based on an expected treatment effect of 0.50C on post-intervention preoperative peripheral foot temperature. We assumed a type 1 error (alpha) of 0.05 for a two tailed test and a correlation coefficient of 0.8 for temperature measures taken within each individual. A sample size of 274 patients, divided into two groups, is estimated to provide 90% power. An extra 54 patients will be recruited to the study to allow for a 20% buffer for withdrawals of patients who become ineligible due to extended surgery times or for incomplete data collection. The data will be grouped in pre-, intra- and post-operative and if data in either of these sections is incomplete others can still be analyzed. The total sample size will be 328 patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2013
Actual
12/02/2013
Date of last participant enrolment
Anticipated
Actual
4/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
328
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2907 0
Lismore Base Hospital - Lismore
Recruitment postcode(s) [1] 8633 0
2480 - Lismore

Funding & Sponsors
Funding source category [1] 289825 0
Government body
Name [1] 289825 0
Health Education and Training Institute
Country [1] 289825 0
Australia
Primary sponsor type
Individual
Name
Michael Koenen
Address
Lismore Base Hospital
Operating Theatre
Uralba Street
Lismore, NSW 2480
Country
Australia
Secondary sponsor category [1] 288517 0
None
Name [1] 288517 0
Address [1] 288517 0
Country [1] 288517 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291558 0
North Coast NSW Human Research Ethics Committee
Ethics committee address [1] 291558 0
Research Ethics Officer
NCNSW Human Research Ethics Committee
PO Box 821
Murwillumbah NSW 2484
Ethics committee country [1] 291558 0
Australia
Date submitted for ethics approval [1] 291558 0
Approval date [1] 291558 0
12/12/2012
Ethics approval number [1] 291558 0
LNR 048

Summary
Brief summary
Inadvertent perioperative hypothermia (IPH) is a common problem for patients undergoing surgery. Heat redistribution from the body’s core to the periphery after induction of anaesthesia is the major contributor to heat loss.
Both cotton and reflective blankets are currently in routine use in operating theatres for perioperative warming of patients undergoing short procedures.
This study aims to determine if thermal insulation with reflective blankets is more effective than cotton blankets in reducing the temperature gradient from the body’s periphery to the core during the preoperative phase in adult patients undergoing short surgery and thus in reducing the intraoperative drop in core temperature.
Trial website
Trial related presentations / publications
not applicable
Public notes

Contacts
Principal investigator
Name 50874 0
Mr Michael Koenen
Address 50874 0
Lismore Base Hospital
Operating Theatre
60 Uralba Street
Lismore, NSW 2480
Country 50874 0
Australia
Phone 50874 0
61 2 66202580
Fax 50874 0
Email 50874 0
[email protected]
Contact person for public queries
Name 50875 0
Mr Michael Koenen
Address 50875 0
Lismore Base Hospital
Operating Theatre
60 Uralba Street
Lismore, NSW 2480
Country 50875 0
Australia
Phone 50875 0
61 2 66202580
Fax 50875 0
Email 50875 0
[email protected]
Contact person for scientific queries
Name 50876 0
Mr Michael Koenen
Address 50876 0
Lismore Base Hospital
Operating Theatre
60 Uralba Street
Lismore, NSW 2480
Country 50876 0
Australia
Phone 50876 0
61 2 66202580
Fax 50876 0
Email 50876 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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