Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000401055
Ethics application status
Approved
Date submitted
12/05/2010
Date registered
18/05/2010
Date last updated
18/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tracheal intubation using Clarus Video system in non-paralyzed patients with normal airway.
Scientific title
Comparison of vocal cord exposure between paralyzed and non-paralyzed patients during tracheal intubation using Clarus video system
Secondary ID [1] 251769 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients scheduled for various surgical procedures requiring tracheal intubation as part of anaesthesia 257351 0
Condition category
Condition code
Anaesthesiology 257496 257496 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anaesthesia will be induced with target-controlled infusion of propofol 5 µg / ml and remifentanil 4 ng / ml, 2 min later, succinylcholine 1.5 mg / kg or comparable volume of saline will be injected according to the group of succinylcholine or saline. Participants in the succinylcholine group will receive one succinylcholine injection only. In both groups, after visual confirm of the vocal cord, saline or succinylcholine will be injected intravenously, while patient’s airway being suspended with Clarus and endo-tracheal tube will be passed into trachea. This procedure will take 5 minutes.
Intervention code [1] 256469 0
Treatment: Surgery
Intervention code [2] 256498 0
Treatment: Drugs
Comparator / control treatment
succinylcholine 1.5 mg / kg or comparable volume of saline will be injected in pre-filled syringes according to the group of succinylcholine or saline
Control group
Placebo

Outcomes
Primary outcome [1] 258425 0
visual confirmation of vocal cord through indirect vision of Clarus video system
Timepoint [1] 258425 0
time at exposure of vocal cord
Secondary outcome [1] 264200 0
success rate for intubation : confirmation through capnography
Timepoint [1] 264200 0
time at intubation
Secondary outcome [2] 264201 0
number of attempts for successful vocal cord exposure : through counting
Timepoint [2] 264201 0
time at vocal cord exposure
Secondary outcome [3] 264202 0
number of optimization maneuver for vocal cord exposure;
through counting
Timepoint [3] 264202 0
time at vocal cord exposure
Secondary outcome [4] 264203 0
hemodynamics: systolic/diastolic blood pressure, heart rate monitoring via non-invasive method; automatic sphygmomanometer, echocardiogram (ECG).
Timepoint [4] 264203 0
before, during the procedure, 1 and 5 min after intubation
Secondary outcome [5] 264204 0
blood on the device, dental or lip injury, postoperative sore throat, hoarseness and dysphagia: visual observation, visual analogue scale.
Timepoint [5] 264204 0
after the procedure, when patients discharging the recovery room

Eligibility
Key inclusion criteria
American society of anesthesiologists physical status (ASA) I or II
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
increased risk of pulmonary aspiration, cervical spine pathology, history of difficult tracheal intubation, ASA physical status = 3, thyromental distance < 5 cm, and Mallapati class > 4

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2625 0
Korea, Republic Of
State/province [1] 2625 0

Funding & Sponsors
Funding source category [1] 256965 0
Self funded/Unfunded
Name [1] 256965 0
jie ae kim
Country [1] 256965 0
Korea, Republic Of
Primary sponsor type
Individual
Name
jie ae kim
Address
Jie Ae Kim, M.D., Ph.D., Associate professor in Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University school of medicine, 50, Irwon-dong, Gangnam-gu, Seoul, Korea 135-710
Country
Korea, Republic Of
Secondary sponsor category [1] 256216 0
Individual
Name [1] 256216 0
myung joo kim
Address [1] 256216 0
Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University school of medicine, 50, Irwon-dong, Gangnam-gu, Seoul, Korea 135-710
Country [1] 256216 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258953 0
institutional review board
Ethics committee address [1] 258953 0
Samsung Medical Center, Sungkyunkwan University school of medicine, 50, Irwon-dong, Gangnam-gu, Seoul, Korea 135-710
Ethics committee country [1] 258953 0
Korea, Republic Of
Date submitted for ethics approval [1] 258953 0
Approval date [1] 258953 0
Ethics approval number [1] 258953 0

Summary
Brief summary
A new, optical video stylet, Clarus Video system, was evaluated for tracheal intubation in paralyzed and non-paralyzed patients with normal airway.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31154 0
Address 31154 0
Country 31154 0
Phone 31154 0
Fax 31154 0
Email 31154 0
Contact person for public queries
Name 14401 0
jie ae kim
Address 14401 0
Associate professor in Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University school of medicine, 50, Irwon-dong, Gangnam-gu, Seoul, Korea 135-710
Country 14401 0
Korea, Republic Of
Phone 14401 0
+82.2-3410-2470
Fax 14401 0
Email 14401 0
jakim0813@yahoo.com
Contact person for scientific queries
Name 5329 0
jie ae kim
Address 5329 0
Associate professor in Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University school of medicine, 50, Irwon-dong, Gangnam-gu, Seoul, Korea 135-710
Country 5329 0
Korea, Republic Of
Phone 5329 0
+82.2-3410-2470
Fax 5329 0
Email 5329 0
jakim0813@yahoo.com

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.