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Trial registered on ANZCTR


Registration number
ACTRN12620001321932p
Ethics application status
Submitted, not yet approved
Date submitted
5/11/2020
Date registered
7/12/2020
Date last updated
7/12/2020
Date data sharing statement initially provided
7/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of air humidification and warming on surgical site temperature during spinal surgery.
Scientific title
Effect of Air Surgical Humidification on wound temperature during spinal surgery. A randomised controlled pilot.
Secondary ID [1] 302635 0
CIA-286
Universal Trial Number (UTN)
U1111-1257-0011
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical wound heat loss 319551 0
Orthopaedic surgery 319552 0
Condition category
Condition code
Surgery 317500 317500 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name of intervention: Air Surgical Humidification

Air Surgical Humidification is a therapy designed and manufactured by Fisher and Paykel Healthcare Ltd. to deliver warm (~37°C) saturated air (~95% relative humidity) to the surgical wound intraoperatively.

Air Surgical Humidification comprises a patient interface that is connected to a heated circuit, humidification system and flow source, and is designed to evenly distribute flow of warm humidified air over the open wound. The patient interface delivers warm humidified air at a flow rate of 10 L/min to create a local atmosphere of warm (~37°C) saturated air in the open surgical wound.

Twenty-eight patients who fit the study criteria and consent to participate will be randomized, 1:1, to receive standard of care (no intervention) or Air Surgical Humidification (intervention) during their spinal decompression surgery.

The intervention will be applied by an orthopaedic surgeon to patients in person, individually to each patient, during their spinal decompression surgery procedure only (as soon as the incision is made until the surgical incision wound is closed), with the surgery performed in the hospital. The intervention will not be personalised, titrated or adapted to individuals or groups of individuals in the intervention arm. Standard of care will be followed in all other aspects of the procedure as is routine at the participating hospital for patients undergoing elective spinal decompression surgery.

Adherence to the intervention, or any protocol deviations and/or adverse events will be recorded in the Case Report Form. Further, the times at which the incision is made, the intervention is applied, the surgical wound is closed, and the intervention is removed will also be recorded on the Case Report Form.
Intervention code [1] 318950 0
Treatment: Devices
Comparator / control treatment
The comparator/control treatment group will not receive the Air Surgical Humidification intervention during their spinal decompression surgery (i.e. no additional treatment)
Control group
Active

Outcomes
Primary outcome [1] 325586 0
Local wound temperature, measured using a thermal camera.
(The maximum, minimum, and average temperature within the wound area for each timepoint will be extracted from the thermal image with computer post-processing.)
Timepoint [1] 325586 0
Upon incision, and thereafter at 15-minute intervals until wound closure. Additionally, one post-operative measurement will be made in the recovery room / PACU, approximately 30 minutes after wound closure.
Secondary outcome [1] 388462 0
Core body temperature as measured by nasopharyngeal probe
Timepoint [1] 388462 0
Upon incision, and thereafter at 15-minute intervals until wound closure.

Eligibility
Key inclusion criteria
1) Undergoing elective 1 or 2 level spinal decompression (laminectomy or laminectomy and discectomy) between L1-S1 vertebrae, performed by a participating surgeon

2) Has had adequate time to consider their participation in the study and discuss it with family and friends, and have their questions answered by a member of the study team

3) Understands the risks and benefits of the study, and able to provide written informed consent.
Minimum age
22 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Undergoing any concomitant procedure

2) Procedures where the final wound incision length could foreseeably be longer than 160mm.

3) Skin sensitivity where 3M™ Ioban™ 2 surgical dressing cannot be used

4) Patients with active medical or psychiatric conditions or participation in another clinical trial which, in the opinion of the PI / operating surgeon, would compromise (or interfere with) their ability to participate in the study, or means that it would not be in their best interest to participate.

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 participant will be randomised to receive either standard of care (control) or Air Surgical Humidification (intervention).
Sealed, opaque envelopes will be used for randomized allocation to control or intervention arms.
Patients who consent to participate will be assigned a participant trial number on the day of surgery. The envelope with the corresponding participant number will then be opened to reveal which study arm the participant must be allocated to - control or intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A 1:1 allocation sequence will be generated by the sponsor, prior to commencement of the study, using a computer generated random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data from previous investigations which examined the effect of warm humidified CO2 on surgical wound temperature and core temperature in patients undergoing colorectal surgery were assessed, and using bootstrap strategy it was determined that 11 participants per group will provide 80% power at 5% significance.
Assuming a drop-out of ~20%, a sample size of 14 per group (total of 28 participants) should be sufficient for the investigation objectives assuming a similar effect size to warm humidified insufflation with CO2 in the abdominal cavity.

We anticipate 28 patients would be recruited over a period of 20 weeks.

Statistical significance will be determined using the independent sample t-test for normally distributed data, or Mann Whitney-U test for nonparametric data.
Continuous variables will be analysed using the independent samples t-test (reporting mean and standard deviation) and Mann Whitney U (reporting median and interquartile range) test for parametric and non-parametric data respectively. The Shapiro-Wilk test will be used to assess normality of data as well as assessment of the data histogram. A p-value of <0.05 will mean that the data are not normally distributed.
Multiple linear regression to adjust for covariate data including age, gender, current medications. Where data are not normally distributed for the primary outcome, continuous data will be log-transformed prior to regression analysis.
We will use SPSS version 24 to analyse all data and 2-sided p values of <0.05 will be deemed significant, and 95% confidence intervals presented where appropriate.
Categorical data will be analysed using the Chi-squared test or Fischer’s exact test where appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 23086 0
New Zealand
State/province [1] 23086 0
Auckland

Funding & Sponsors
Funding source category [1] 307066 0
Commercial sector/Industry
Name [1] 307066 0
Fisher & Paykel Healthcare Limited
Address [1] 307066 0
15 Maurice Paykel Place
East Tamaki, Auckland 2013

Country [1] 307066 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare Limited
Address
15 Maurice Paykel Place
East Tamaki, Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 307636 0
None
Name [1] 307636 0
Address [1] 307636 0
Country [1] 307636 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307190 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 307190 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 307190 0
New Zealand
Date submitted for ethics approval [1] 307190 0
09/11/2020
Approval date [1] 307190 0
Ethics approval number [1] 307190 0

Summary
Brief summary
When the body is opened during surgery, internal tissues are exposed to the air in the operating theatre, which is cold and dry compared to body conditions. The purpose of the study device is to prevent drying and cooling of the surgical wound and internal tissues, by gently delivering warm and humidified air over the wound. The goal of the study is to measure the effectiveness of the study device at maintaining the normal temperature of the internal tissues.
The Air Surgical Humidification device being studied is designed to deliver warm (~37°C) saturated air (~ greater than or equal to 95% relative humidity) to a surgical wound intraoperatively, to prevent evaporation and local heat loss. It comprises a patient interface and heated delivery circuit, which is connected to a humidification system and flow source, and is designed to create an even distribution of flow over the open wound.
Twenty eight patients aged 22 years and older undergoing elective 1 or 2 level spinal decompression (discectomy and/or laminectomy) between L1-S1 vertebrae who fit the study criteria and consent to take part will be randomized to receive standard of care (no intervention) or Air Surgical Humidification during their surgery. A thermal photo of the surgical site (without any identifying information) will be taken upon incision, and thereafter at 15-minute intervals during the surgery until wound closure. Core temperature from a nasopharyngeal probe will also be recorded immediately upon incision and at 15-minute intervals during the surgery until closure.
Post-operatively, thermal photos (without any identifying information) will be taken of the dressed surgical wound while the patient is in recovery, 30 minutes after wound closure during routine post op checks.
Any adverse events and/or re-admissions will be recorded for approximately 6 weeks until the patient's routine post op visit and clinical follow-up. Re-admissions and clinical visits for any reason will be monitored via Middlemore Hospital's patient tracking system which flags the patient's participation in a clinical study on their patient records.
The data resulting from this study will allow us to determine whether warmed and humidified air can help to maintain normal tissue temperature during surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106342 0
Dr Simon Manners
Address 106342 0
Middlemore Hospital
Private Bag 93311,
Otahuhu, Auckland 1640
Country 106342 0
New Zealand
Phone 106342 0
+64 09 2760000
Fax 106342 0
Email 106342 0
Simon.Manners@middlemore.co.nz
Contact person for public queries
Name 106343 0
Dr Callum Spence
Address 106343 0
Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place,
East Tamaki, Auckland 2013
Country 106343 0
New Zealand
Phone 106343 0
+64 09 5740123
Fax 106343 0
Email 106343 0
Callum.Spence@fphcare.co.nz
Contact person for scientific queries
Name 106344 0
Dr Callum Spence
Address 106344 0
Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place,
East Tamaki, Auckland 2013
Country 106344 0
New Zealand
Phone 106344 0
+64 09 5740123
Fax 106344 0
Email 106344 0
Callum.Spence@fphcare.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised data relating to the primary outcome (local surgical wound temperature) and secondary outcome (core temperature)
When will data be available (start and end dates)?
Beginning 6 months, and ending 5 years, following main results publication
Available to whom?
1. Investigators with applicable consents and ethical approvals.
2. Regulatory bodies
Available for what types of analyses?
Meta analyses or similar reviews
Data verification
How or where can data be obtained?
Following a written request, if the Principal Investigator and Sponsor both approve, anonymised data will be made available in an electronic file format.
To request data, please email: Callum.Spence@fphcare.co.nz
What supporting documents are/will be available?
No other documents available
Summary results
No Results