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Trial registered on ANZCTR


Registration number
ACTRN12621000438853
Ethics application status
Approved
Date submitted
2/02/2021
Date registered
16/04/2021
Date last updated
19/04/2022
Date data sharing statement initially provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous Temperature monitoring for Maintenance of Perioperative Thermoregulation (Co-TEMPT): a pilot study.
Scientific title
Continuous Temperature monitoring for Maintenance of Perioperative Thermoregulation (Co-TEMPT) in adult patients: a pilot study.
Secondary ID [1] 302782 0
Nil
Universal Trial Number (UTN)
Trial acronym
Co-TEMPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perioperative hypothermia 319726 0
Condition category
Condition code
Surgery 317659 317659 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
On arrival to the pre-operative holding area, and prior to the induction of anaesthesia, the zero heat flux monitoring Bair Hugger™ device will be attached to the forehead, above the orbital ridge. The placement of the device will be undertaken by the registered nurse working in the pre-operative holding area. The Research Nurse will be present for assistance. The device then requires a ramp-up time of three minutes for temperature readings to stabilise. The ZHF (Bair Hugger™) device will be utilized until patients are assessed as ‘ready for discharge’ from the Post Anaesthetic Care Unit (PACU). Treatment adherence and fidelity will be prospectively monitored and assessed via direct observation.
Intervention code [1] 319058 0
Prevention
Comparator / control treatment
Pre-post design: data will be prospectively collected from 40 patients prior to and, following a wash-out period of 20 patients, for 40 patients post-introduction of the ZHF,
Control group
Active

Outcomes
Primary outcome [1] 325710 0
Feasibility: composite outcome (as appropriate for a pilot study)including
- numbers of patients screened, and numbers of participants recruited (retrospectively assessed via recruitment log)
- retention (retrospectively assessed via study log)
-treatment adherence and fidelity (retrospectively assessed via activity log)
-missing data (percentage) (retrospectively assessed via data collection form)
- device failure (number and reason) (prospectively assessed and recorded via data collection form)
- adverse outcomes (ie adverse reaction to zero-heat-flux device) (prospectively assessed and recorded via data collection form)
- data collection time (in hours, retrospectively assessed via activity log)
Timepoint [1] 325710 0
End of study.
Secondary outcome [1] 388869 0
Intervention Feasibility and acceptability (composite outcome)
- Acceptability of Intervention (AIM) via AIM tool distributed via staff survey
- Intervention Appropriateness Measure (IAM) via IAM tool distributed via staff survey
- Feasibility of Intervention Measure (FIM) via FIM tool distributed via staff survey
- Practicality assessed by 5-piont Likert scale distributed via staff survey
Timepoint [1] 388869 0
Via staff survey at the end of patient data collection.
Secondary outcome [2] 392555 0
Clinical effectiveness outcome:
- Temperature documentation assessed via retrospective chart review
Timepoint [2] 392555 0
• within hour prior to transfer to the perioperative department;
• on arrival to holding area;
• immediately prior to anaesthesia induction
• intraoperatively every 15 minutes where forced air warming is place or every 30 minutes for all patients;
• on admission to Post Anaesthetic Care Unit (PACU);
• every 15 minutes in PACU;
• prior to ‘ready for discharge’ decision and upon discharge from PACU
Secondary outcome [3] 393660 0
Clinical effectiveness outcome:
- Perioperative hypothermia incidence (<36 degrees Celsius) assessed via retrospective chart review
Timepoint [3] 393660 0
within hour prior to transfer to the perioperative department;
• on arrival to holding area;
• immediately prior to anaesthesia induction
• intraoperatively every 15 minutes where forced air warming is place or every 30 minutes for all patients;
• on admission to Post Anaesthetic Care Unit (PACU);
• every 15 minutes in PACU;
• prior to ‘ready for discharge’ decision and upon discharge from PACU
Secondary outcome [4] 393661 0
Clinical effectiveness outcome:
- Documented warming interventions: intravenous (IV) fluid warming, forced air or other active warming measure assessed via retrospective chart review
Timepoint [4] 393661 0
within hour prior to transfer to the perioperative department;
• on arrival to holding area;
• immediately prior to anaesthesia induction
• intraoperatively every 15 minutes where forced air warming is place or every 30 minutes for all patients;
• on admission to Post Anaesthetic Care Unit (PACU);
• every 15 minutes in PACU;
• prior to ‘ready for discharge’ decision and upon discharge from PACU
Secondary outcome [5] 393662 0
Clinical Effectiveness outcome:
- Appropriateness of warming (cross-referenced and assessed against temperature and the ACORN Standard for the Management of Hypothermia in the Perioperative Environment) assessed via retrospective chart review
Timepoint [5] 393662 0
within hour prior to transfer to the perioperative department;
• on arrival to holding area;
• immediately prior to anaesthesia induction
• intraoperatively every 15 minutes where forced air warming is place or every 30 minutes for all patients;
• on admission to Post Anaesthetic Care Unit (PACU);
• every 15 minutes in PACU;
• prior to ‘ready for discharge’ decision and upon discharge from PACU

Eligibility
Key inclusion criteria
The patient population will include consenting adults undergoing elective surgery (expected duration > 30 minutes), under general, or neuraxial anaesthesia, with an American Society of Anesthesiologists (ASA) score I-III.
The health care professional population will include consenting perioperative nurses, technicians and anaesthetists caring for patient participants.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients undergoing surgery with an expected procedural duration of less than 30 minutes, patients undergoing local anaesthesia only or local Anesthesia with sedation, or patients with known sensitivity to adhesives, or forehead rash on the day of admission, will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable - non-randomised trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable - non-randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Basic demographic data, pilot and feasibility outcomes will be summarised. All data will be presented as mean, median, percentages and ranges, as appropriate. Paired t-tests will be used to assess whether documentation, use of warming where clinically indicated, proportion of hypothermia changes post-introduction of ZHF. The significance level will be set to <0.05. Effect size for pre and post temperature documentation will be used to generate post-hoc sample size calculations for the required sample size for the future cluster randomised trial. Feasibility, appropriateness and practicality data will be summarised.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2021
Actual
30/06/2021
Date of last participant enrolment
Anticipated
1/07/2021
Actual
4/04/2022
Date of last data collection
Anticipated
1/07/2021
Actual
4/04/2022
Sample size
Target
100
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18564 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 32937 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 307200 0
University
Name [1] 307200 0
Centre for Healthcare Transformation, Queensland University of Technology
Country [1] 307200 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Rd, Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 307806 0
None
Name [1] 307806 0
Address [1] 307806 0
Country [1] 307806 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307307 0
Metro South Hospital and Health Service (MSHHS) Human Research Ethics Committee
Ethics committee address [1] 307307 0
199 Ipswich Rd, Woolloongabba QLD 4102
Ethics committee country [1] 307307 0
Australia
Date submitted for ethics approval [1] 307307 0
Approval date [1] 307307 0
29/01/2021
Ethics approval number [1] 307307 0

Summary
Brief summary
Temperature imbalance during surgery results in adverse outcomes for patients, however temperature is rarely monitored in accordance with guidelines. One key barrier to regular, consistent and documented temperature monitoring during surgery is a lack of a non-invasive, but accurate temperature monitoring device. This pilot study will assess feasibility of recruitment, protocol fidelity, sample size and process evaluation for a future cluster randomised study testing the impact of a non-invasive, continuous temperature monitoring device upon clinical practice and patient outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106770 0
Dr Judy Munday
Address 106770 0
QUT Centre for Healthcare Transformation/ School of Nursing, N Block, Victoria Park Rd, Kelvin Grove, QLD 4059
Country 106770 0
Australia
Phone 106770 0
+61 7 31388209
Fax 106770 0
Email 106770 0
[email protected]
Contact person for public queries
Name 106771 0
Judy Munday
Address 106771 0
QUT Centre for Healthcare Transformation/ School of Nursing, N Block, Victoria Park Rd, Kelvin Grove, QLD 4059
Country 106771 0
Australia
Phone 106771 0
+61 7 31388209
Fax 106771 0
Email 106771 0
[email protected]
Contact person for scientific queries
Name 106772 0
Judy Munday
Address 106772 0
QUT Centre for Healthcare Transformation/ School of Nursing, N Block, Victoria Park Rd, Kelvin Grove, QLD 4059
Country 106772 0
Australia
Phone 106772 0
+61 7 31388209
Fax 106772 0
Email 106772 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
SourceTitleYear of PublicationDOI
EmbaseImplementation of continuous temperature monitoring during perioperative care: a feasibility study.2022https://dx.doi.org/10.1186/s13037-022-00341-w
N.B. These documents automatically identified may not have been verified by the study sponsor.