Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001514291
Ethics application status
Approved
Date submitted
30/07/2018
Date registered
10/09/2018
Date last updated
13/11/2018
Date data sharing statement initially provided
13/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The assessment of diaphragm muscle in children undergoing adenoid-tonsillectomy operation.
Scientific title
The assessment of diaphragm muscle thickness with US in children undergoing adenoid-tonsillectomy operation.
Secondary ID [1] 295077 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Adenoidectomy 308131 0
Condition category
Condition code
Oral and Gastrointestinal 307168 307168 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. Explanation of how to evaluate diaphragm muscle thickness:
a) the approximate time to perform the measurement is 20-30 seconds,
b) the measurement does not have an association with the operation or the surgery region, and
c) Ultrasonic measurement shall be made 4 times in total, basal, after intubation, before extubation and after extubation.
2. Medical doctor will administer the ultrasound.
Intervention code [1] 301407 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306866 0
-diaphragm thickness values (using ultrasound)
Timepoint [1] 306866 0
Before and after intubation ; before and after extubation .
Secondary outcome [1] 351457 0
-operation time( is asssessed with stop watch)
Timepoint [1] 351457 0
-End of the operation.

Eligibility
Key inclusion criteria
Patients with pediatric age group with ASA 1 and 2 physical status who will undergo adenotonsillectomy operation between 2-12 years of age will be examined.
Minimum age
2 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a physical defect that interferes with ultrasound examinations, children's parents who are illiterate in Turkish, do not have normal mental capacity, and do not agree to participate in the study will not be included.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be presented continuously variables as mean SD. X 2 tests will be used to assess differences in groups
for the categorical variables. Sensitivity, specificity, positive predictive
value (PPV) and negative predictive value (NPV) will be
calculated for ultrasound derived measurements of tdi in the groups in predicting
extubation success.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/09/2018
Actual
11/11/2018
Date of last participant enrolment
Anticipated
26/11/2018
Actual
Date of last data collection
Anticipated
3/12/2018
Actual
Sample size
Target
60
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 10680 0
Turkey
State/province [1] 10680 0
KONYA

Funding & Sponsors
Funding source category [1] 299658 0
Hospital
Name [1] 299658 0
Konya Public Hospitals Association, Health Sciences University, Konya Meram Education and Research Hospital, Konya, Turkey
Country [1] 299658 0
Turkey
Primary sponsor type
Hospital
Name
Konya Public Hospitals Association, Health Sciences University, Konya Meram Education and Research Hospital, Konya, Turkey
Address
Haci Saban Mah. Yeni Meram Cad. No:97 Meram / KONYA
Country
Turkey
Secondary sponsor category [1] 299654 0
None
Name [1] 299654 0
Address [1] 299654 0
Country [1] 299654 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300557 0
Necmettin Erbakan University, Meram Faculty of Medicine Ethics Committee
Ethics committee address [1] 300557 0
Ethics committee country [1] 300557 0
Turkey
Date submitted for ethics approval [1] 300557 0
29/05/2018
Approval date [1] 300557 0
01/06/2018
Ethics approval number [1] 300557 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84054 0
Dr Yasin Tire
Address 84054 0
Haci Saban Mah. Yeni Meram Cad. No:97 Meram / KONYA
Health Science University Konya Education and Research Hospital
Country 84054 0
Turkey
Phone 84054 0
+90 332 221 00 00
Fax 84054 0
+90 332 324 1854
Email 84054 0
dryasintire@hotmail.com
Contact person for public queries
Name 84055 0
Yasin Tire
Address 84055 0
Haci Saban Mah. Yeni Meram Cad. No:97 Meram / KONYA
Health Science University Konya Education and Research Hospital
Country 84055 0
Turkey
Phone 84055 0
+90 332 221 00 00
Fax 84055 0
+90 332 324 1854
Email 84055 0
dryasintire@hotmail.com
Contact person for scientific queries
Name 84056 0
Yasin Tire
Address 84056 0
Haci Saban Mah. Yeni Meram Cad. No:97 Meram / KONYA
Health Science University Konya Education and Research Hospital
Country 84056 0
Turkey
Phone 84056 0
+90 332 221 00 00
Fax 84056 0
+90 332 324 1854
Email 84056 0
dryasintire@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In principle, I don't share my patients' datas.


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.