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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
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Scientific title
The effect of head positioning on intraoperative carotid blood flow and postoperative cognitive function of adult patients undergoing thyroidectomy
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Secondary ID [1]
299432
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None
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Universal Trial Number (UTN)
U1111-1241-1562
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
multi nodular goitre
314622
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cognitive dysfunction
314623
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Condition category
Condition code
Anaesthesiology
312962
312962
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0
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Other anaesthesiology
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Surgery
312963
312963
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0
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Other surgery
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Mental Health
312964
312964
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0
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Studies of normal psychology, cognitive function and behaviour
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Metabolic and Endocrine
313665
313665
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0
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
315680
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Postoperative cognitive function of patients between groups by using Montreal Cognitive Assessment test scores
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Assessment method [1]
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Timepoint [1]
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The day before the surgery, postoperative 6th hour (primary timepoint)
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Secondary outcome [1]
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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)
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Assessment method [1]
375315
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Timepoint [1]
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After the positioning of the head in the intraoperative period
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Secondary outcome [2]
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difference of volume flow changes between T1-T3 between groups, which will be calculated by doppler ultrasonography
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Assessment method [2]
375363
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Timepoint [2]
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At the end of the operation (T3)
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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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
11/02/2020
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Actual
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Date of last participant enrolment
Anticipated
15/04/2020
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Actual
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Date of last data collection
Anticipated
15/04/2020
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Actual
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Sample size
Target
46
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
21896
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Turkey
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State/province [1]
21896
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Mugla
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Mugla Sitki Koçman University Training and Research Hospital
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Address [1]
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Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 Mentese/MUGLA
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Country [1]
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Turkey
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Primary sponsor type
Individual
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Name
Basak Altiparmak
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Address
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 Mentese/MUGLA
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Country
Turkey
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
304094
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Country [1]
304094
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
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Ethics committee address [1]
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Mugla Sitki Koçman University Training and Research Hospital, Marmaris Yolu üzeri, M Kapi Karsisi, 48000 Mugla
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Ethics committee country [1]
304438
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Turkey
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Date submitted for ethics approval [1]
304438
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30/01/2020
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Approval date [1]
304438
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04/02/2020
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Ethics approval number [1]
304438
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9/ii
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Basak ALTIPARMAK
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Address
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Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
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Country
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Turkey
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Phone
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+905326726533
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Basak ALTIPARMAK
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Address
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Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
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Country
96955
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Turkey
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Phone
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+905326726533
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Fax
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Email
96955
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Basak ALTIPARMAK
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Address
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Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
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Country
96956
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Turkey
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Phone
96956
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+905326726533
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Fax
96956
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Email
96956
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
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When will data be available (start and end dates)?
Between immediately following publication and ending 1 year following main results publication
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Available to whom?
only researchers who provide a methodologically sound proposal
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Available for what types of analyses?
only to achieve the aims in the approved proposal
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How or where can data be obtained?
access subject to approvals by Principal Investigator (Basak ALTIPARMAK email:
[email protected]
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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.
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