Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000136000
Ethics application status
Approved
Date submitted
27/12/2009
Date registered
10/02/2010
Date last updated
10/02/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of the Airtraq laryngoscope for bariatric surgery: influence of positioning
Scientific title
Assessing the time to intubation between intubation with the airtraq laryngoscope compared to the Macintosh laryngoscope in obese candidates for bariatric surgery
Secondary ID [1] 1222 0
None
Universal Trial Number (UTN)
U1111-1113-0857
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficulties in intubation in obese patients with Airtraq laryngoscope 256450 0
Condition category
Condition code
Anaesthesiology 256619 256619 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Observe: Time to intubation, visual conditions, and oxygen levels, during the use of the Airtraq(trademark), laryngoscope, in obese patients at sniffing position. The time to intubation with the airtraq usually is made in 120 seconds. We will observe teh use of this device when the patient is at the called "sniffing position". This position is obteined with put pillows and blankets under back, neck and head.
The airtraq is a rigid device and we need a bucal aperture of 2cm at least. Its needs less cervical and head movimentation for tracheal tube introdution. The anesthesiologist can see the larynx through a small screen. The larynx image cames to screen from a prisma
Intervention code [1] 255740 0
Treatment: Devices
Comparator / control treatment
We will compare with the traditional Macintosh laryngoscope. This is the traditional aproach of the airway in obese patients positioned in the sniffing position. Its takes about 1 to 3 minutos to do (intubation), and sometimes its can fail. Because the risk of failure and hypoxia we decided to try an alternative device (airtraq)
Control group
Active

Outcomes
Primary outcome [1] 257511 0
Time to procedure intubation. When we are to proced an anesthesia in the obese patient, the time to intubation is very important because after the anesthetics effects, the abdominal fat pushes the lungs up and the tongue and larynx soft tissue falls and makes the ventilantion and oxygenations difficult, sometimes impossible. To avoid it we need to proced the intubation quickie. Our study aim is the compare between airtraq and macintosh laryngoscopes, wich one can make it easier and faster.
Timepoint [1] 257511 0
At baseline
Secondary outcome [1] 262731 0
Visual field of the larynx.
There are a classification pourposed by Cormak and Lehane, about the vision of the laryngeal structures during a laryngoscopy. It is universaly used. The classifications have 4 grades. Grade I, we can see all structures. Grade II, we can see just the vocal cords partially. Grade III, we see only the epiglotys, and Grade IV, we can not see the larynx. All airway devices try to do a best vision, Grade I
Timepoint [1] 262731 0
At baseline
Secondary outcome [2] 262732 0
Oxygen level during intubation time.
Using a non invasive continuous pulse oximeter (Dash 3000, General Eletric, USA)
Timepoint [2] 262732 0
At baseline

Eligibility
Key inclusion criteria
Obese patients scheduled for bariatric surgery, after signed the Ethical Reconmendations
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refuse to participate.Non trated hiatal reflux, history of allergic reactions to succinilcoline or difficult intubation, bucal aperture less than 2cm.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
By sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 2376 0
Brazil
State/province [1] 2376 0
Santa Catarina

Funding & Sponsors
Funding source category [1] 256216 0
Self funded/Unfunded
Name [1] 256216 0
Dante Ranieri Junior
Country [1] 256216 0
Brazil
Funding source category [2] 256455 0
Self funded/Unfunded
Name [2] 256455 0
Country [2] 256455 0
Brazil
Primary sponsor type
Individual
Name
Dante Ranieri Junior
Address
Rua XV de Novembro, 222 apartment 10
Itajai - Santa catarina - Brazil
ZIP 88301420
Country
Brazil
Secondary sponsor category [1] 251554 0
Hospital
Name [1] 251554 0
Hospital do Coracao de Balneario Camboriu
Address [1] 251554 0
Rua Arthur Maxdoose, 215
Balneario Camboriu
Country [1] 251554 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258315 0
Comite de Etica em Pesquisa da Univali
Ethics committee address [1] 258315 0
Ethics committee country [1] 258315 0
Brazil
Date submitted for ethics approval [1] 258315 0
02/07/2009
Approval date [1] 258315 0
16/10/2009
Ethics approval number [1] 258315 0
362/09A

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

Contacts
Principal investigator
Name 30645 0
Address 30645 0
Country 30645 0
Phone 30645 0
Fax 30645 0
Email 30645 0
Contact person for public queries
Name 13892 0
Dante Ranieri Junior
Address 13892 0
XV Novembro, 222 ap 10
Itajai
Santa Catarina
ZIP 88301420
Country 13892 0
Brazil
Phone 13892 0
55-47-33492176
Fax 13892 0
55-47-33492176
Email 13892 0
[email protected]
Contact person for scientific queries
Name 4820 0
Dante Ranieri Junior
Address 4820 0
XV Novembro, 222 ap 10
Itajai
Santa catarina
ZIP 88301420
Country 4820 0
Brazil
Phone 4820 0
55-47-33492176
Fax 4820 0
55-47-33492176
Email 4820 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
EmbasePreanesthetic assessment data do not influence the time for tracheal intubation with Airtraq video laryngoscope in obese patients.2014
N.B. These documents automatically identified may not have been verified by the study sponsor.