Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000532303
Ethics application status
Approved
Date submitted
14/02/2017
Date registered
11/04/2017
Date last updated
11/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of ultrasound measurements of anterior neck soft tissue and other predictors of difficult laryngoscopy in morbidly obese patients
Scientific title
Evaluation of ultrasound measurements of anterior neck soft tissue and other predictors of difficult laryngoscopy in morbidly obese patients undergoing obesity surgery
Secondary ID [1] 290958 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
difficult laryngoscopy 301690 0
Condition category
Condition code
Anaesthesiology 301397 301397 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
observational study included (Older than 18 years old
ASA (American Society of Anesthesiologists) I-II
Body Mass Index (BMI) >35 kg/m2
Laparoscopic weight reduction surgery (sleeve gastrectomy)
Under general anaesthesia with endotracheal intubation.
Patients (Patients who had upper airway pathologies (maxillo-facial fracture, tumours, etc), pathology causing limitation in head-neck movement (cervical spine fractures, rhomatoid artiritis, ankylozan spondilitis, etc), contraindication of general anaesthesia (history of malign hiperthermia, full stomach, etc) or a history of difficult laryngoscopy or intubation were excluded from study.
Mallampati test, mouth opening, sternomental distance, thyromental distance, upper lip bite test, neck circumference were recorded. The distance from the skin to the anterior aspect of the trachea was measured at three different levels: vocal cords (zone 1), thyroid isthmus (zone 2) and suprasternal notch (zone 3). An anaesthesiologist who were unaware of the clinical screening variables and ultrasonography results performed laryngoscopy. When second attempt for intubation was failed, to use of other difficult intubation equipments were planned. Each participant was followed up until the end of the operation
Intervention code [1] 297608 0
Early Detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300793 0
Primary outcome: The determining ultrasound measurements of 3 different levels ( Vocal cords, Thyroid isthmus, Suprasternal notch) of anterior neck soft tissue: this is a composite primary outcome.
Timepoint [1] 300793 0
Will be evaluated 30 mins before the operation
Secondary outcome [1] 330867 0
Secondary Outcome: clinical screening test for detecting of difficult laryngoscopy:
Obstructive sleep apnea syndrome (OSAS), assessed by review of medical records about patient's history of OSAS.
Timepoint [1] 330867 0
Will be evaluated 24 hours before the operation
Secondary outcome [2] 333124 0
Mouth openning (cm), assessed using a caliper.
Timepoint [2] 333124 0
30 mins before the operation
Secondary outcome [3] 333125 0
Modified Mallampati Score
Timepoint [3] 333125 0
30 mins before the operation
Secondary outcome [4] 333126 0
Thyromental distance (cm), assessed using a caliper.
Timepoint [4] 333126 0
30 mins before the operation
Secondary outcome [5] 333127 0
Sternomental distance (cm), assessed using a caliper.
Timepoint [5] 333127 0
30 mins before the operation
Secondary outcome [6] 333128 0
Cormack&Lehane score
Timepoint [6] 333128 0
30 mins before the operation
Secondary outcome [7] 333129 0
Intubation Difficulty Scale (IDS)
Timepoint [7] 333129 0
15 mins after endotracheal entubation
Secondary outcome [8] 333131 0
Wilson risk sum score
Timepoint [8] 333131 0
30 mins before the operation
Secondary outcome [9] 333133 0
Neck circumference measured at the thyroid cartilage, assessed using a caliper.
Timepoint [9] 333133 0
30 mins before the operation

Eligibility
Key inclusion criteria
Older than 18 years old
ASA (American Society of Anesthesiologists) I-II
Body Mass Index (BMI) >35 kg/m2
Laparoscopic weight reduction surgery (sleeve gastrectomy)
Under general anaesthesia with endotracheal intubation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who had upper airway pathologies (maxillo-facial fracture, tumours, etc), pathology causing limitation in head-neck movement (cervical spine fractures, rhomatoid artiritis, ankylozan spondilitis, etc), contraindication of general anaesthesia (history of malign hiperthermia, full stomach, etc) or a history of difficult laryngoscopy or intubation were excluded from study.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/05/2015
Date of last participant enrolment
Anticipated
Actual
15/07/2015
Date of last data collection
Anticipated
Actual
15/08/2015
Sample size
Target
130
Accrual to date
Final
74
Recruitment outside Australia
Country [1] 8660 0
Turkey
State/province [1] 8660 0
BURSA

Funding & Sponsors
Funding source category [1] 295603 0
Hospital
Name [1] 295603 0
Health Sciences University Bursa Yuksek Ihtisas Training and Education Hospital
Country [1] 295603 0
Turkey
Primary sponsor type
Individual
Name
Canan Yilmaz
Address
Health Sciences University Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anasthesiology and Reanimation Mimar Sinan Neighbohood/Emniyet Street/16310 Yildirim/Bursa
Country
Turkey
Secondary sponsor category [1] 294438 0
Individual
Name [1] 294438 0
Derya Karasu
Address [1] 294438 0
Health Sciences University Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anasthesiology and Reanimation Mimar Sinan Neighbohood/Emniyet Street/16310 Yildirim/Bursa
Country [1] 294438 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296922 0
Health Sciences University Bursa Yuksek Ihtisas Training and Education Hospital Clinical Research Ethics Committee
Ethics committee address [1] 296922 0
Ethics committee country [1] 296922 0
Turkey
Date submitted for ethics approval [1] 296922 0
25/04/2014
Approval date [1] 296922 0
14/05/2014
Ethics approval number [1] 296922 0
2014/10/01

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

Contacts
Principal investigator
Name 71834 0
Dr Canan Yilmaz
Address 71834 0
Health Sciences University Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anasthesiology and Reanimation Mimar Sinan Neighbohood/Emniyet Street/16310 Yildirim/Bursa
Country 71834 0
Turkey
Phone 71834 0
+905059045989
Fax 71834 0
Email 71834 0
[email protected]
Contact person for public queries
Name 71835 0
Derya Karasu
Address 71835 0
Health Sciences University Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anasthesiology and Reanimation Mimar Sinan Neighbohood/Emniyet Street/16310 Yildirim/Bursa
Country 71835 0
Turkey
Phone 71835 0
+905057281175
Fax 71835 0
Email 71835 0
[email protected]
Contact person for scientific queries
Name 71836 0
Seyda Efsun OZGUNAY
Address 71836 0
Health Sciences University Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anasthesiology and Reanimation Mimar Sinan Neighbohood/Emniyet Street/16310 Yildirim/Bursa
Country 71836 0
Turkey
Phone 71836 0
+905359723603
Fax 71836 0
Email 71836 0
[email protected]

No information has been provided regarding IPD availability


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.