Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000211662
Ethics application status
Approved
Date submitted
18/02/2014
Date registered
27/02/2014
Date last updated
27/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Incidence of difficult tracheal intubation in bariatric surgery patients.
Scientific title
Patients undergoing bariatric surgery, An observation of tracheal intubation incidence of difficulty.
Secondary ID [1] 284115 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
incidence of difficult tracheal intubation 291192 0
Condition category
Condition code
Anaesthesiology 291528 291528 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Hours
Description of intervention(s) / exposure
we observe the difficulty of endotracheal tube insertion using the Intubation Difficulty Scale. The following factors were recorded and scored: number of attempts, number of operators, number of alternative techniques, Cormack-Lehane grade, Use of lifting force, Need for laryngyeal pressure and Mobility of vocal cords.
Intervention code [1] 288808 0
Not applicable
Comparator / control treatment
Not applicable - Observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291496 0
The intubation difficulty score for the patients.
Timepoint [1] 291496 0
at the time of intubation for bariatric surgery.
Secondary outcome [1] 306907 0
use of external maneuvers
Timepoint [1] 306907 0
at the time of intubation for bariatric surgery.
Secondary outcome [2] 306908 0
use of rescue maneuvers
Timepoint [2] 306908 0
at the time of intubation for bariatric surgery.

Eligibility
Key inclusion criteria
1- BMI > 35
2- participants are undergoing bariatric surgery.
3- ASA I and II
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- BMI < 35
2- ASA III and IV
3- Known previous difficult airway

Study design
Purpose
Natural history
Duration
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2013
Actual
1/07/2013
Date of last participant enrolment
Anticipated
1/07/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5836 0
Bahrain
State/province [1] 5836 0

Funding & Sponsors
Funding source category [1] 288745 0
Self funded/Unfunded
Name [1] 288745 0
Shahid Adeel
Country [1] 288745 0
Bahrain
Primary sponsor type
Hospital
Name
King Hamad University Hospital
Address
King Hamad University Hospital, Anaesthesia department PO box 24343
Bahrain
Country
Bahrain
Secondary sponsor category [1] 287440 0
None
Name [1] 287440 0
Not applicable
Address [1] 287440 0
Not applicable
Country [1] 287440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290586 0
Research and Ethics Committee at King Hamad University Hospital
Ethics committee address [1] 290586 0
PO Box 24343
Bahrain
Ethics committee country [1] 290586 0
Bahrain
Date submitted for ethics approval [1] 290586 0
Approval date [1] 290586 0
18/06/2013
Ethics approval number [1] 290586 0

Summary
Brief summary
This is an observational study that is being carried out at King Hamad University Hospital (KHUH) in Bahrain.
Participants for the study included all patients scheduled to undergo Bariatric Surgery with a BMI of >35. Patients were excluded if they were less than 18 years old, or had a BMI of < 35.

Data collected included patient’s age, gender, weight, height and comorbidities. Pre-operative Anaesthetic Assessment involves noting the procedure the patient is scheduled to undergo, concurrent illnesses, previous surgeries and history of receiving anaesthesia. Patient’s current medications and allergies are noted. Along with standard pre-operative Assessment, anaesthesiologists ensured recording different measurements including, Neck circumference, Mouth opening (Inter-incisor distance) and any teeth abnormalities.

During the procedure, the position of the patient was noted, along with the induction agents used and size of scope used. Intra-operative assessment was assessed using the Intubation Difficulty Scale. The following factors were recorded and scored: number of attempts, number of operators, number of alternative techniques, Cormack grade, Use of lifting force, Need for laryngyeal pressure and Mobility of vocal cords.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46314 0
Dr Shahid Adeel
Address 46314 0
King Hamad University Hospital, anaesthesia department, po box 24343
Bahrain
Country 46314 0
Bahrain
Phone 46314 0
+97333301673
Fax 46314 0
Email 46314 0
[email protected]
Contact person for public queries
Name 46315 0
Dr Shahid Adeel
Address 46315 0
King Hamad University Hospital, anaesthesia department, po box 24343
Bahrain
Country 46315 0
Bahrain
Phone 46315 0
+97333301673
Fax 46315 0
Email 46315 0
[email protected]
Contact person for scientific queries
Name 46316 0
Dr Ahmed Mamdouh
Address 46316 0
King Hamad University Hospital, anaesthesia department po box 24343
Bahrain
Country 46316 0
Bahrain
Phone 46316 0
+97334365308
Fax 46316 0
Email 46316 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
SourceTitleYear of PublicationDOI
EmbaseDifficult tracheal intubation in bariatric surgery patients, a myth or reality?.2016https://dx.doi.org/10.1093/bja/aew039
N.B. These documents automatically identified may not have been verified by the study sponsor.