Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000025235
Ethics application status
Approved
Date submitted
20/03/2017
Date registered
12/01/2018
Date last updated
12/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does fixed dental prostheses in the front teeth cause anesthesiologists to have difficulty in intubating patients?
Scientific title
Does fixed dental prostheses in the front teeth cause difficult intubation?
Secondary ID [1] 291486 0
nil known
Universal Trial Number (UTN)
U 1111-1194-4359
Trial acronym
Linked study record
NONE

Health condition
Health condition(s) or problem(s) studied:
ELECTIVE SURGERY 302553 0
FIXED DENTAL PROSTHESES 302554 0
DIFFICULT INTUBATION 302555 0
Condition category
Condition code
Anaesthesiology 302086 302086 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will make our measurements prior to the procedure, which will take about 3-4 minutes as total. We will measure neck circumference, hyromental distance, sternomental distance, mandibula hyoid distance, atlantoccipital joint movement, upper lip bite test, calder test, interincisor distance, angle between upper teeth and horizontal plane and angle between mouth corner- tragus line and horizontal plane, modified mallampati score, Cormach lahane score in elective surgery ASA 1-2 patients with fixed dental prostheses and without dental prostheses
Intervention code [1] 297556 0
Not applicable
Comparator / control treatment
we will take two groups in elective surgeries. one group with fixed dental prosthesisin the front teeth and the other one control group without dental prosthesis. All ASA 1-2 groups with elective surgery 18 to 65 years
Control group
Active

Outcomes
Primary outcome [1] 301526 0
Comparison of the rate of difficult intubation between patients with and without fixed dental prosthesis on the front teeth, assessed by Cormach lahane score. Difficult intubation defined as Cormach lahane score 3 or 4.
Timepoint [1] 301526 0
during intubation
Secondary outcome [1] 333721 0
neck circumference is measured by tape measure
Timepoint [1] 333721 0
we will make measurements prior to surgery
Secondary outcome [2] 334941 0
thyrohyoid distances are measured using a tape measure.
Timepoint [2] 334941 0
prior to surgery
Secondary outcome [3] 334944 0
mandibulohyoid distance are measured using a tape measure.
Timepoint [3] 334944 0
prior to surgery
Secondary outcome [4] 334947 0
Angle between mouth corner- tragus line and horizontal plane are measured by goniometer
Timepoint [4] 334947 0
prior to surgery
Secondary outcome [5] 334948 0
Upper lip bite test
Timepoint [5] 334948 0
prior to surgery
Secondary outcome [6] 334949 0
Modified mallampati score
if modified mallampati score is high, it means we will have a difficulty in intubation
Timepoint [6] 334949 0
during intubation
Secondary outcome [7] 335945 0
calder test
Timepoint [7] 335945 0
prior to surgery
Secondary outcome [8] 335946 0
cormack lehane
if cormack lehane score is 3 or 4, it means we will have difficultly in intubation
Timepoint [8] 335946 0
during intubation
Secondary outcome [9] 335947 0
thyromental distance was measured in cms as straight line from thyroid notch to lower border of mentum with head extended in all patients with standart measuring tape
Timepoint [9] 335947 0
prior to surgery
Secondary outcome [10] 335948 0
sternomental distance is the distance from border suprasternal notch to the lower mentum was measured in cms using a standart measuring tape
Timepoint [10] 335948 0
prior to surgery
Secondary outcome [11] 335949 0
atlantoccipital joint movement
The patient is asked to hold head erect facing directly to the front then is asked to extend the head maximally and the examiner measures the angle traversed by the occlusal surface of upper teeth using a goniometer
Timepoint [11] 335949 0
prior to surgery
Secondary outcome [12] 335952 0
when lying supine with patients head at extension, we measure the angle between mouth corner- tragus line and horizontal plane by goniometer
Timepoint [12] 335952 0
prior to surgery

Eligibility
Key inclusion criteria
we will take elective surgery patients, with ASA1-2
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patiens younger than 18
older than 65
ASA 3,4,5
urgent surgery

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
A total of 116 patients have a %90 power

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/01/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
119
Accrual to date
Final
Recruitment outside Australia
Country [1] 8750 0
Turkey
State/province [1] 8750 0

Funding & Sponsors
Funding source category [1] 295967 0
Self funded/Unfunded
Name [1] 295967 0
Gozde Bumin Aydin
Country [1] 295967 0
Turkey
Primary sponsor type
Individual
Name
gozde bumin aydin
Address
lDiskapi Yildirim Beyazit Education and Reasearch Hospital. Irfan Bastug caddesi no 12. Altindag Ankara Turkey 06510
Country
Turkey
Secondary sponsor category [1] 294853 0
None
Name [1] 294853 0
none
Address [1] 294853 0
none
Country [1] 294853 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297238 0
SB Diskapi Yildirim Beyazit Training and Education Hospital
Ethics committee address [1] 297238 0
Irfan Bastug caddesi no 12
Altindag
Ankara
06510
Ethics committee country [1] 297238 0
Turkey
Date submitted for ethics approval [1] 297238 0
Approval date [1] 297238 0
22/11/2016
Ethics approval number [1] 297238 0

Summary
Brief summary
We will measure neck circumference, thyromental distance, sternomental distance, mandibula hyoid distance, atlantoccipital joint movement, upper lip bite test, calder test, interincisor distance, angle between upper teeth and horizontal plane and angle between mouth corner- tragus line and horizontal plane, modified mallampati score, Cormach lahane score in elective surgery, aged between 18-65, ASA 1-2 patients with fixed dental prostheses in the front teeth and without dental prostheses
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1631 1631 0 0
/AnzctrAttachments/372591-2.docx (Protocol)
Attachments [2] 1632 1632 0 0
/AnzctrAttachments/372591(v11-04-2017-18-12-23)-1.docx (Ethics approval)
Attachments [3] 1633 1633 0 0
/AnzctrAttachments/372591-3.docx (Protocol)

Contacts
Principal investigator
Name 73422 0
A/Prof gozde bumin aydin
Address 73422 0
Diskapi Yildirim Beyazit Education and Reasearch Hospital. Irfan Bastug caddesi no 12. Altindag Ankara Turkey 06510
Country 73422 0
Turkey
Phone 73422 0
+905326453235
Fax 73422 0
Email 73422 0
[email protected]
Contact person for public queries
Name 73423 0
A/Prof gozde bumin aydin
Address 73423 0
Diskapi Yildirim Beyazit Education and Reasearch Hospital. Irfan Bastug caddesi no 12. Altindag Ankara Turkey 06510
Country 73423 0
Turkey
Phone 73423 0
+905326453235
Fax 73423 0
Email 73423 0
[email protected]
Contact person for scientific queries
Name 73424 0
A/Prof gozde bumin aydin
Address 73424 0
Diskapi Yildirim Beyazit Education and Reasearch Hospital. Irfan Bastug caddesi no 12. Altindag Ankara Turkey 06510
Country 73424 0
Turkey
Phone 73424 0
+905326453235
Fax 73424 0
Email 73424 0
[email protected]

No information has been provided regarding IPD availability


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Current supporting documents:


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