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Trial registered on ANZCTR


Registration number
ACTRN12620000099921
Ethics application status
Approved
Date submitted
30/09/2019
Date registered
5/02/2020
Date last updated
5/02/2020
Date data sharing statement initially provided
5/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of head positioning on intraoperative carotid blood flow and postoperative cognitive function of patients undergoing thyroidectomy
Scientific title
The effect of head positioning on intraoperative carotid blood flow and postoperative cognitive function of adult patients undergoing thyroidectomy
Secondary ID [1] 299432 0
None
Universal Trial Number (UTN)
U1111-1241-1562
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
multi nodular goitre 314622 0
cognitive dysfunction 314623 0
Condition category
Condition code
Anaesthesiology 312962 312962 0 0
Other anaesthesiology
Surgery 312963 312963 0 0
Other surgery
Mental Health 312964 312964 0 0
Studies of normal psychology, cognitive function and behaviour
Metabolic and Endocrine 313665 313665 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The cognitive functions of the patients will be evaluated with Montreal cognitive assessment test (MoCA) at the day before surgery. Before induction of general anesthesia, an anesthesiologist will perform doppler ultrasonographic measurements of each patient (T0) over carotid artery. Then the patients will be randomly allocated into two groups. Patients will be positioned with a special pillow called Dunhill pillow in Group 1. Dunhill pillow is a jelly pillow designed to support shoulder blades of a patient where extension of the neck is needed. A standard shoulder roll will be placed under the shoulders of patients in Group 2. The doppler ultrasonographic evaluation will be repeated after the induction(T1) , after positioning of the patient (T2) and at the end of the surgery (T3). The cognitive functions of the patients will be re-evaluated with MoCA at the postoperative 6th hour.
Intervention code [1] 315680 0
Treatment: Other
Comparator / control treatment
Patients who are scheduled for thyroidectomy will be positioned with a standard shoulder roll in Group 2 (control group). Cognitive function evaluation and doppler ultrasonographic measurements will be performed in all patients at all time-points.
Control group
Active

Outcomes
Primary outcome [1] 321542 0
Postoperative cognitive function of patients between groups by using Montreal Cognitive Assessment test scores
Timepoint [1] 321542 0
The day before the surgery, postoperative 6th hour (primary timepoint)
Secondary outcome [1] 375315 0
The mean degree of neck extension which will be calculated on a lateral view-photograph by an application named Angles in Photos (copyright (c) 2015 kublaios)
Timepoint [1] 375315 0
After the positioning of the head in the intraoperative period
Secondary outcome [2] 375363 0
difference of volume flow changes between T1-T3 between groups, which will be calculated by doppler ultrasonography
Timepoint [2] 375363 0
At the end of the operation (T3)

Eligibility
Key inclusion criteria
The patients with American Society of Anesthesiologists (ASA) physical status I-II, between 18-65 years old and scheduled for an elective thyroidectomy surgery
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with preoperative Montreal cognitive assessment test score under 24, known psychological disorder, inability of the patient to communicate, hemoglobin level lower than 8 mg dL-1, known hyperlipidemia, hypertension or diabetes mellitus, cerebrovascular disorders, BMI over 40 kg m-2, surgical time shorter than 90 min or longer than 120 minutes

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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)
Safety
Statistical methods / analysis
We will conduct the statistical analysis using the software Statistical Package for Social Science (SPSS), version 17 (made by SPSS Incorporated, located in Chicago, Illinois, USA). All continuous variables including age, weight, height, body mass index will be presented below as mean and standard deviation (?SD), and the categorical variables, gender ASA scores, will be presented as both numbers and percentile (%). The relationship between Frankfort plane angle and changes analyzed by regression model. Repeated measures analysis will be performed for changes in doppler ultrasound values (volume flow, maximum volume, TAP and diameter). Moreover, Post hoc analyses were performed using Bonferroni correction for multiple comparisons, since the time wise differences were statistically significant in all parameters observed.

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] 21896 0
Turkey
State/province [1] 21896 0
Mugla

Funding & Sponsors
Funding source category [1] 303942 0
Hospital
Name [1] 303942 0
Mugla Sitki Koçman University Training and Research Hospital
Address [1] 303942 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 Mentese/MUGLA
Country [1] 303942 0
Turkey
Primary sponsor type
Individual
Name
Basak Altiparmak
Address
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 Mentese/MUGLA
Country
Turkey
Secondary sponsor category [1] 304094 0
None
Name [1] 304094 0
Address [1] 304094 0
Country [1] 304094 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304438 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 304438 0
Mugla Sitki Koçman University Training and Research Hospital, Marmaris Yolu üzeri, M Kapi Karsisi, 48000 Mugla
Ethics committee country [1] 304438 0
Turkey
Date submitted for ethics approval [1] 304438 0
30/01/2020
Approval date [1] 304438 0
04/02/2020
Ethics approval number [1] 304438 0
9/ii

Summary
Brief summary
The head and neck are positioned with varying degrees of extension during thyroidectomy. The conventional approach is to place a shoulder roll behind the patient’s shoulders to extend the neck before surgical incision. Sometimes, a special silicone pillow which is called “Dunhill pillow” is used to support the head, neck and shoulders. However, hyperextension of the neck was reported to be associated with some series complications such asocclusion in the carotid and vertebral arteries. Therefore, the position may result in impaired postoperative cognitive functions related to decreased arterial blood flow during thyroidectomy surgery.In the current study, Our primary hypothesis is that patients positioned with Dunhill pillow will have lower MoCA scores at the postoperative 6th hour than the patients positioned with a shoulder roll. Our secondary hypothesis is that the mean blood flow in the carotid artery of the patients in Dunhill pillow group will be lower than the shoulder roll group at the end of the operation. Another secondary hypothesis is that the degree of head extension will be higher in the Dunhill pillow group than the shoulder roll group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96954 0
A/Prof Basak ALTIPARMAK
Address 96954 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 96954 0
Turkey
Phone 96954 0
+905326726533
Fax 96954 0
Email 96954 0
basak_ugurlu@yahoo.com
Contact person for public queries
Name 96955 0
A/Prof Basak ALTIPARMAK
Address 96955 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 96955 0
Turkey
Phone 96955 0
+905326726533
Fax 96955 0
Email 96955 0
basak_ugurlu@yahoo.com
Contact person for scientific queries
Name 96956 0
A/Prof Basak ALTIPARMAK
Address 96956 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 96956 0
Turkey
Phone 96956 0
+905326726533
Fax 96956 0
Email 96956 0
basak_ugurlu@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Between immediately following publication and ending 1 year following main results publication
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator (Basak ALTIPARMAK email: basak_ugurlu@yahoo.com).
What supporting documents are/will be available?
No other documents available
Summary results
No Results