Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000157774
Ethics application status
Approved
Date submitted
30/09/2021
Date registered
31/01/2022
Date last updated
23/09/2022
Date data sharing statement initially provided
31/01/2022
Date results information initially provided
23/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Suspension Laryngoscopy Application on Optic Nerve Sheath Diameter, an Indirect Indicator of Increased Intracranial Pressure
Scientific title
Evaluation of the Effect of Suspension Laryngoscopy on Optic Nerve Sheath Diameter: An Observational Study
Secondary ID [1] 305411 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
suspension laryngoscopy 323781 0
Raised intracranial pressure 323782 0
Condition category
Condition code
Surgery 321293 321293 0 0
Other surgery
Anaesthesiology 321294 321294 0 0
Other anaesthesiology
Neurological 322020 322020 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Hours
Description of intervention(s) / exposure
Optic nerve sheath diameter (ONSD) measurement will be performed by ultrasonography (USG) at 5 different times in patients undergoing suspension laryngoscopy. Participants will be monitored from the time of commencement of suspension laryngoscopy to the time of discharge from the post-anaesthesia care unit. Suspension laryngoscopy is expected to take at most 1 hour. ONSD measurements will be made by a trained anesthesiologist. An 8.0 megahertz linear USG probe applied with a thin layer of gel will be carefully placed on the closed upper eyelid. Avoiding excessive pressure, the probe will be adjusted to show the optic nerve entry into the eyeball in 2D mode. The image will be frozen after optimal contrast is achieved between the hypoechoic image of the optic nerve and the echogenicity of the retrobulbar adipose tissue. ONSD will be measured 3 mm behind the optic disc using the electronic caliper of the USG. The measurement will be made 4 times, 2 horizontal and 2 vertical, for a single eye, and the average of these 4 measurements will be considered as ONSD. Measurements will be repeated at 5 different times and from the same eye. The times to be measured; It will be defined as T0 (after induction of anesthesia), T1 (immediately after intubation), T2 (with the head in extension at the beginning of the suspension laryngoscopy), T3 (at the end of the suspension laryngoscopy), T4 (with the head in a neutral position 5 minutes after the suspension laryngoscopy is terminated). During these 5 times, along with ONSD measurements, patients' heart rate, noninvasive mean arterial pressure, end-tidal CO2 values, saturation values, peak inspiratory pressure values will also be recorded. All patients' ages, genders, ASA scores, Mallampati scores, body mass indexes (BMI) will be recorded. Suspension laryngoscopy times will also be recorded. It will also be recorded how long after the patients were awakened, they were compiled. For this, the Modified Aldrete Score will be used, and if this score is 9 and above, the patient will be considered compiled.
Intervention code [1] 321848 0
Early Detection / Screening
Intervention code [2] 322346 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329118 0
Change in optic nerve sheath diameter will be assessed using ultrasonography.
Timepoint [1] 329118 0
Intraoperative 5 different time point
Assessed intraoperatively at T0 (after induction of anesthesia), T1 (immediately after intubation), T2 (with the head in extension at the beginning of the suspension laryngoscopy,primary timepoint), T3 (at the end of the suspension laryngoscopy), and T4 (with the head in a neutral position 5 minutes after the suspension laryngoscopy is terminated)
Secondary outcome [1] 401530 0
Compilation time will be assessed using the Modified Aldrete Score.
Timepoint [1] 401530 0
Mean arterial pressure will be assessed intraoperatively at T0 (after induction of anesthesia), T1 (immediately after intubation), T2 (with the head in extension at the beginning of the suspension laryngoscopy), T3 (at the end of the suspension laryngoscopy), and T4 (with the head in a neutral position 5 minutes after the suspension laryngoscopy is terminated)
Secondary outcome [2] 403730 0
Heart rate will be assessed by using electrocardiogram monitorization
Timepoint [2] 403730 0
Mean arterial pressure will be assessed intraoperatively at T0 (after induction of anesthesia), T1 (immediately after intubation), T2 (with the head in extension at the beginning of the suspension laryngoscopy), T3 (at the end of the suspension laryngoscopy), and T4 (with the head in a neutral position 5 minutes after the suspension laryngoscopy is terminated)
Secondary outcome [3] 403731 0
Mean arterial pressure will be measured noninvasively using a blood pressure cuff.
Timepoint [3] 403731 0
Mean arterial pressure will be assessed intraoperatively at T0 (after induction of anesthesia), T1 (immediately after intubation), T2 (with the head in extension at the beginning of the suspension laryngoscopy), T3 (at the end of the suspension laryngoscopy), and T4 (with the head in a neutral position 5 minutes after the suspension laryngoscopy is terminated)
Secondary outcome [4] 403732 0
Saturation value will be assessed by using pulse oximeter monitorization.
Timepoint [4] 403732 0
Mean arterial pressure will be assessed intraoperatively at T0 (after induction of anesthesia), T1 (immediately after intubation), T2 (with the head in extension at the beginning of the suspension laryngoscopy), T3 (at the end of the suspension laryngoscopy), and T4 (with the head in a neutral position 5 minutes after the suspension laryngoscopy is terminated)
Secondary outcome [5] 403733 0
End-tidal CO2 values will be assessed by using capnogram.
Timepoint [5] 403733 0
Mean arterial pressure will be assessed intraoperatively at T0 (after induction of anesthesia), T1 (immediately after intubation), T2 (with the head in extension at the beginning of the suspension laryngoscopy), T3 (at the end of the suspension laryngoscopy), and T4 (with the head in a neutral position 5 minutes after the suspension laryngoscopy is terminated)
Secondary outcome [6] 403734 0
Peak inspiratory pressure values will be assessed by using anaesthesia machine monitor.
Timepoint [6] 403734 0
Mean arterial pressure will be assessed intraoperatively at T0 (after induction of anesthesia), T1 (immediately after intubation), T2 (with the head in extension at the beginning of the suspension laryngoscopy), T3 (at the end of the suspension laryngoscopy), and T4 (with the head in a neutral position 5 minutes after the suspension laryngoscopy is terminated)

Eligibility
Key inclusion criteria
ASA I-III, 18-90 years old patients who will undergo suspension laryngoscopy will be included in the study.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with intracranial pathology, a history of cerebrovascular disease, a history of ocular pathology or disease, and pregnant women will be excluded from the study.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be analyzed using SPSS 20.0 Windows version. All continuous variables including age, BMI, ONSD, EtCO2, heart rate, and mean arterial pressure will be given as mean ± SD. Categorical variables will be given as both numbers and percentages (%). Whether there is a difference between the two groups in demographic data will be determined using the t test. A linear mixed model will be used to observe the change of repeated ONSD measurements and other parameters over time. Post hoc analysis will be performed using Bonferroni correction for multiple comparisons. P values below 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/02/2022
Actual
7/02/2022
Date of last participant enrolment
Anticipated
30/04/2022
Actual
7/07/2022
Date of last data collection
Anticipated
30/04/2022
Actual
7/07/2022
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 24156 0
Turkey
State/province [1] 24156 0

Funding & Sponsors
Funding source category [1] 309773 0
University
Name [1] 309773 0
Necmettin Erbakan University Meram Faculty of Medicine
Country [1] 309773 0
Turkey
Primary sponsor type
University
Name
Necmettin Erbakan University Meram Faculty of Medicine
Address
Hocacihan Neighbourhood Abdülhamid Han Street Number:3 Post Code:42080 Selçuklu/Konya
Country
Turkey
Secondary sponsor category [1] 310804 0
None
Name [1] 310804 0
None
Address [1] 310804 0
None
Country [1] 310804 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309527 0
Necmettin Erbakan University Non-Pharmaceutical and Medical Device Research Ethics Committee
Ethics committee address [1] 309527 0
Hocacihan Neighborhood Abdülhamid Han Street Number:3 Post Code:42080 Selçuklu/Konya
Ethics committee country [1] 309527 0
Turkey
Date submitted for ethics approval [1] 309527 0
Approval date [1] 309527 0
13/09/2021
Ethics approval number [1] 309527 0

Summary
Brief summary
The aim of this study is to investigate whether the long-term suspension applied with direct laryngoscope in suspension laryngoscopy performed for biopsy from suspicious lesions in the rima glottis and its immediate surroundings has an effect on optic nerve sheath diameter and therefore intracranial pressure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114466 0
Dr Gülçin Hacibeyoglu
Address 114466 0
Necmettin Erbakan University Meram Medical Faculty
Hocacihan Neighborhood
Abdülhamid Han Street
Number:3
Post Code:42080
Selçuklu Konya
Country 114466 0
Turkey
Phone 114466 0
+905054455498
Fax 114466 0
Email 114466 0
[email protected]
Contact person for public queries
Name 114467 0
Dr Gülçin Hacibeyoglu
Address 114467 0
Necmettin Erbakan University Meram Medical Faculty
Hocacihan Neighborhood
Abdülhamid Han Street
Number:3
Post Code:42080
Selçuklu Konya
Country 114467 0
Turkey
Phone 114467 0
+905054455498
Fax 114467 0
Email 114467 0
[email protected]
Contact person for scientific queries
Name 114468 0
Dr Gülçin Hacibeyoglu
Address 114468 0
Necmettin Erbakan University Meram Medical Faculty
Hocacihan Neighborhood
Abdülhamid Han Street
Number:3
Post Code:42080
Selçuklu Konya
Country 114468 0
Turkey
Phone 114468 0
+905054455498
Fax 114468 0
Email 114468 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?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Following publication no end date determined
Available to whom?
Only researchers
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 by emailing the Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13416Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 382852-(Uploaded-23-09-2022-05-27-27)-Basic results summary.docx
Plain language summaryNo One of the non-invasive procedures used in intracr... [More Details]

Documents added automatically
No additional documents have been identified.