Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001066178
Ethics application status
Approved
Date submitted
3/06/2019
Date registered
31/07/2019
Date last updated
11/12/2019
Date data sharing statement initially provided
31/07/2019
Date results information initially provided
11/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of head positioning on intraoperative optic nerve sheath diameter and postoperative cognitive function of patients undergoing thyroidectomy
Scientific title
The effect of head positioning on intraoperative optic nerve sheath diameter and postoperative cognitive function of adult patients undergoing thyroidectomy
Secondary ID [1] 298405 0
Nil known
Universal Trial Number (UTN)
U1111-1234-6123
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tyroid cancer 313104 0
mild cognitive impairment 313105 0
Condition category
Condition code
Cancer 311583 311583 0 0
Thyroid
Mental Health 311584 311584 0 0
Studies of normal psychology, cognitive function and behaviour
Anaesthesiology 311586 311586 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the shoulder roll group (Group 1), patients will lie in supine position with arms tucked and a shoulder roll will be placed behind the shoulders of patients to extend the neck during thyroidectomy surgery. Then head of the operation table will be raised up to 30 degrees from the horizontal plane. The degree of neck extension (Frankfort plane angle) will be measured by using the angle between the Frankfort plane and horizontal plane of the operation table in natural position. Cognitive functions of patients will be evaluated with MoCA by a blinded anesthesiologist during the preoperative assessment and visit at the postoperative 6th hour.
Intervention code [1] 314648 0
Diagnosis / Prognosis
Comparator / control treatment
In the second group (Group 2), patients will be placed in the same position and the neck will be extended without a shoulder roll. The degree of neck extension (Frankfort plane angle) will be measured by using the angle between the Frankfort plane and horizontal plane of the operation table in natural position. Cognitive functions of patients will be evaluated with MoCA by a blinded anesthesiologist during the preoperative assessment and visit at the postoperative 6th hour.
Control group
Active

Outcomes
Primary outcome [1] 320289 0
Preoperative (the day before the surgery) and postoperative (at the postoperative 6th hour) cognitive function levels as assessed by MoCA test between the groups
Timepoint [1] 320289 0
At the preoperative assessment (the day before the surgery) and at the postoperative 6th hour (primary timepoint)
Secondary outcome [1] 371081 0
The difference between groups in optic nerve sheath diameter (ONSD) which will be measured by ultrasonography at different time-points
Timepoint [1] 371081 0
(T0) before induction of anesthesia, (T1) after induction of anesthesia, (T2) after endotracheal intubation, (T3) after positioning of the head, (T4) 60 min after the induction of anesthesia, (T5) 90 min after the induction of anesthesia (secondary time-point)
Secondary outcome [2] 371082 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 [2] 371082 0
After the positioning of the head in the intraoperative period

Eligibility
Key inclusion criteria
The patients with American Society of Anesthesiologists (ASA) physical status II, between 18-65 years old and scheduled for an elective thyroidectomy surgery will be included in the study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a preoperative MoCA score under 24, known acute or chronic ophthalmic diseases, history of previous ophthalmic surgery, increased ICP, ß blocker, calcium canal blocker, statin or nitrate treatment, known psychological disorder, BMI over 40 kg m-2, surgical time shorter than 90 min and longer than 120 minutes will be excluded

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation will be determined using a computer software by a researcher who will not involve in the study
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, globe size, ONSD, EtCO2, Temp, HR, MAP will be presented as mean and standard deviation (SD), and the categorical variables, gender and T/AT, will be presented as both numbers and percentile (%). The relationship between Frankfort plane angle and ONSD changes will be analyzed by regression model. Linear mixed model will be used to observe the variation of repeated ONSD measurements and the other parameters (EtCO2, Temp, HR, MAP) over time. Moreover, Post hoc analyses will be performed using Bonferroni correction for multiple comparisons

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2019
Actual
31/07/2019
Date of last participant enrolment
Anticipated
10/09/2019
Actual
14/11/2019
Date of last data collection
Anticipated
11/09/2019
Actual
14/11/2019
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 21557 0
Turkey
State/province [1] 21557 0
Mugla

Funding & Sponsors
Funding source category [1] 302945 0
Hospital
Name [1] 302945 0
Mugla Sitki Koçman University Training and Research Hospital
Country [1] 302945 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] 302908 0
None
Name [1] 302908 0
Address [1] 302908 0
Country [1] 302908 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303507 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 303507 0
Mugla Sitki Koçman University Training and Research Hospital, Marmaris Yolu üzeri, M Kapi Karsisi, 48000 Mugla
Ethics committee country [1] 303507 0
Turkey
Date submitted for ethics approval [1] 303507 0
10/06/2019
Approval date [1] 303507 0
17/06/2019
Ethics approval number [1] 303507 0
T-XII

Summary
Brief summary
Hyperextension of the neck is associated with increased postoperative pain and some series complication such as carotid and vertebral artery occlusion which may lead to postoperative cognitive impairment.In the current study, our primary hypothesis is that patients positioned with a shoulder roll will have lower MoCA scores at the postoperative 6th hour than the patients positioned without a shoulder roll. Our secondary hypothesis is that optic nerve sheath diameter (ONSD) which is accepted as a well indicator of changes in ICP, will be greater in the shoulder roll group. Another secondary hypothesis is that the degree of neck extension will be greater in shoulder roll group.In the shoulder roll group (Group 1), patients will lie in supine position with arms tucked and a standard shoulder roll will be placed behind the shoulders of patients to extend the neck. Then head of the operation table will be raised up to 30 degrees from the horizontal plane. In the second group (Group 2), patients will be placed in the same position and the neck will be extended without a shoulder roll.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93906 0
Dr Basak ALTIPARMAK
Address 93906 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 93906 0
Turkey
Phone 93906 0
+905326726533
Fax 93906 0
Email 93906 0
[email protected]
Contact person for public queries
Name 93907 0
Dr Basak ALTIPARMAK
Address 93907 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 93907 0
Turkey
Phone 93907 0
+905326726533
Fax 93907 0
Email 93907 0
[email protected]
Contact person for scientific queries
Name 93908 0
Dr Basak ALTIPARMAK
Address 93908 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 93908 0
Turkey
Phone 93908 0
+905326726533
Fax 93908 0
Email 93908 0
[email protected]

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: [email protected])


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.