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
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
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
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
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.