Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000682741
Ethics application status
Approved
Date submitted
17/03/2022
Date registered
11/05/2022
Date last updated
19/02/2024
Date data sharing statement initially provided
11/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Body temperature of patients during sedation for endoscopic procedures: an observational study.
Scientific title
Investigating changes in the body temperature of patients during procedural sedation for endoscopic procedures : an observational study.
Secondary ID [1] 306679 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypothermia 325681 0
Condition category
Condition code
Anaesthesiology 323027 323027 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Body temperature of patients undergoing endoscopic procedures with procedural sedation will be continuously monitored immediately prior, during and immediately after the procedure. Endoscopic procedures including lower endoscopy and complex upper endoscopy procedures, which are anticipated to exceed 30minutes in duration will be included. Continuous temperature monitoring will be commenced by the Research Nurse, and retrieved retrospectively.
Participants will be asked to complete surveys on:
- Thermal comfort via a 100mm visual analogue scale at baseline, pre-procedure and post-procedure timepoints
- Satisfaction via the 21-item gastrointestinal endoscopy satisfaction questionnaire (GESQ) at one day post-endoscopy via email or hard copy questionnaire. Anticipated time to complete: 15 minutes. Reference: Hutchings HA, Cheung W-Y, Alrubaiy L, et al. Development and validation of the gastrointestinal endoscopy satisfaction questionnaire (GESQ). Endoscopy. 2015;47(12):1137-43.
Follow up - one day post-procedure (for completion of GESQ - see above).
The temperature monitoring device to be used in not novel, in that it is available and approved for use in Australia and used in perioperative and procedural settings for monitoring temperature. It will only be applied to patients who choose to enrol to allow for a consistent method of measuring temperature in this study. Whilst in this local setting, patients do not consistently receive temperature monitoring, ACSQHC recommend that temperature is a minimum requirement for inclusion in patient monitoring plans (National Consensus Statement: Essential elements for recognising and responding to acute physiological deterioration (ACSQHC, 2017). Therefore, temperature monitoring should be standard practice and our choice of device needs to be consistent to meet the aims of this observational study, just as the tools we used to measure thermal comfort or satisfaction are. We are not testing the utility or accuracy or applicability of the device. Therefore, this study is not an interventional study.
Intervention code [1] 323156 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330792 0
Mean temperature changes (degrees Celsius) from baseline to end of procedure via the zero-heat-flux Bair Hugger device.
Timepoint [1] 330792 0
Baseline (pre-procedure) to end of procedure.
Secondary outcome [1] 407585 0
Mean temperature change (degrees Celsius) from baseline to end of anaesthesia recovery period (prior to discharge from Endoscopy Unit) using the zero-heat-flux Bair Hugger temperature monitoring device.
Timepoint [1] 407585 0
Baseline (pre-procedure) to end of recovery period.
Secondary outcome [2] 407586 0
Incidence of hypothermia (defined as a temperature less than 36 degrees Celsius) using the zero-heat-flux Bair Hugger temperature monitoring device.
Timepoint [2] 407586 0
Measured at any time point (temperature measured in 5 minute intervals) from baseline to end of recovery period.
Secondary outcome [3] 407587 0
Shivering (via a three-point scale) - the unnamed scale has been used in many previous temperature studies, including
Woolnough M, Allam J, Hemingway C, Cox M, Yentis SM.
Intra-operative fluid warming in elective caesarean section: a blinded randomised controlled trial. Int J Obstet Anesth. 2009;18:346–351.

Saito T, Sessler DI, Fujita K, Ooi Y, Jeffrey R. Thermoregulatory effects of spinal and epidural anesthesia during cesarean delivery. Reg Anesth Pain Med. 1998;23:418–423.

Munday J, Osborne S, Yates P, Sturgess D, Jones L, Gosden E. Preoperative warming versus no preoperative warming for maintenance of normothermia in women receiving intrathecal morphine for cesarean delivery: a single-blinded, randomized controlled trial. Anesthesia & Analgesia. 2018 Jan 1;126(1):183-9.
Timepoint [3] 407587 0
On admission, pre-procedure, post-procedure at 30 minutes.
Secondary outcome [4] 407588 0
Thermal comfort (via a 100mm Visual Analogue Scale)
Timepoint [4] 407588 0
On admission, pre-procedure, post-procedure at 30 minutes.
Secondary outcome [5] 407589 0
Readmission: incidence and reason - composite measure. Assessed via linkage to medical records.
Timepoint [5] 407589 0
Within 30 days post-procedure.
Secondary outcome [6] 407590 0
Major complication - ie readmission. Assessed via linkage to medical records.
Timepoint [6] 407590 0
Within 30 days post-procedure.
Secondary outcome [7] 407591 0
Patient satisfaction (measured using the Gastrointestinal Endoscopy Satisfaction Questionnaire by Hutchings et al. 2015).
Timepoint [7] 407591 0
One day post-procedure.

Eligibility
Key inclusion criteria
Adults aged 18 years and above receiving procedural sedation for endoscopic procedures (including lower endoscopy and complex upper endoscopy procedures) at the study hospital, on an outpatient basis, are eligible for inclusion, with informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing simple upper endoscopy procedures, patients not providing consent, patients with neck or forehead rash, patients with allergies to adhesives, who do not receive procedural sedation, are receiving care as an inpatient, or whom receive general anaesthesia, will be excluded.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Participant characteristics, as well as surgical and anaesthetic variables, will be summarised descriptively via counts and percentages for categorical data, and means/standard deviations, medians/ranges, as appropriate for continuous data. Mean ambient temperature, shivering and thermal comfort scores at each procedural stage will be reported. Temperature decline will be analysed using linear mixed-model analysis (to allow for fixed effects of baseline temperature and time, and a random intercept for repeated measures) from baseline to the end of procedure, and baseline to end of recovery period. A significance level of p<0.05 will be utilised. SPSS™ Version 26 will be utilised for data analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/06/2022
Actual
3/08/2022
Date of last participant enrolment
Anticipated
15/09/2023
Actual
28/07/2023
Date of last data collection
Anticipated
16/10/2023
Actual
28/07/2023
Sample size
Target
300
Accrual to date
Final
165
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21987 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 37089 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 311010 0
University
Name [1] 311010 0
Queensland University of Technology
Country [1] 311010 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] 312365 0
None
Name [1] 312365 0
Address [1] 312365 0
Country [1] 312365 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310559 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 310559 0
Ethics committee country [1] 310559 0
Australia
Date submitted for ethics approval [1] 310559 0
17/03/2022
Approval date [1] 310559 0
24/05/2022
Ethics approval number [1] 310559 0
24/05/2022

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

Contacts
Principal investigator
Name 118082 0
Dr Judy Munday
Address 118082 0
Queensland University of Technology, Rm 340, N Block, Victoria Park Road, Kelvin Grove, QLD 4059
Country 118082 0
Australia
Phone 118082 0
+61 07 3138 3848
Fax 118082 0
Email 118082 0
[email protected]
Contact person for public queries
Name 118083 0
Judy Munday
Address 118083 0
Queensland University of Technology, Rm 340, N Block, Victoria Park Road, Kelvin Grove, QLD 4059
Country 118083 0
Australia
Phone 118083 0
+61 07 3138 3848
Fax 118083 0
Email 118083 0
[email protected]
Contact person for scientific queries
Name 118084 0
Judy Munday
Address 118084 0
Queensland University of Technology, Rm 340, N Block, Victoria Park Road, Kelvin Grove, QLD 4059
Country 118084 0
Australia
Phone 118084 0
+61 7 3138 3848
Fax 118084 0
Email 118084 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
Individual participant data will be not available to comply with anticipated requirements of ethical approvals.


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.