Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001096044
Ethics application status
Approved
Date submitted
10/12/2010
Date registered
15/12/2010
Date last updated
15/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Airway Scope and Videolight wand laryngoscope in patients with cervical immobilisation by a semi-rigid collar
Scientific title
Comparison of intubation condition by Airway Scope and Videolight wand laryngoscope in patients with cervical immobilisation by a semi-rigid collar
Secondary ID [1] 253274 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 258799 0
Condition category
Condition code
Anaesthesiology 258948 258948 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, after loss of consciousness, rocuronium 0.8 mg/kg will be injected for paralysis. After confirm of full paralysis using train of four ratio of zero(0/4) at the ulnar verve, semi-rigid Philadelphia cervical collar (Philadelphia Cervical Collar Co., NJ, USA) will be applied in neutral position. Patients will be randomly allocated into one of two groups, to receive tracheal intubation with an Airway scope preloaded with a tracheal tube (7 mm internal diameter for women and 8 mm for men) or to receive tracheal intubation with a Videolightwand laryngoscope with a preloaded tube in the same manner. Videolight wand laryngoscope preloaded with a tracheal tube is the intervention in this trial. In both groups, after visual confirmation of vocal cords and advancement of tracheal tube into larynx, respiratory circuit will be connected and ventilation will be confirmed with capnogram and stethoscope. If intubation fails with three trials or with trials lasting longer than 2 minutes, the collar will be detatched and then tracheal intubation with conventional laryngoscope in a sniffing position will be tried.The entire duration of the intervention will be less than 3 minutes.
Intervention code [1] 257731 0
Treatment: Surgery
Intervention code [2] 257732 0
Treatment: Devices
Comparator / control treatment
Airway scope preloaded with a tracheal tube is the control in this trial. The entire duration of the intervention will be less than 3 minutes.
Control group
Active

Outcomes
Primary outcome [1] 259803 0
differences in intubation time (definition: from the insertion of the laryngoscope into mouth to visual confirmation of tracheal tube passage into larynx ) will be assessed by clinical staff
Timepoint [1] 259803 0
Measured once visual confirmation of tracheal tube passage into larynx has been achieved
Primary outcome [2] 259804 0
intubation difficulty score (ref. Journal of Trauma 2010; 69: 838-842) will be assessed by clinical staff
Timepoint [2] 259804 0
Immediately after the completion of each intubation trial
Primary outcome [3] 259805 0
blood pressure will be measured by automated blood pressure cuff
Timepoint [3] 259805 0
before anaesthetic induction, before intubation, during intubation, 1 and 5 minute after intubation
Primary outcome [4] 259806 0
The number of attempts required for successful intubation of the patient as assessed by clinical staff
Timepoint [4] 259806 0
during intubation
Secondary outcome [1] 268603 0
dental or lip injury will be assessed by clinical staff
Timepoint [1] 268603 0
after the procedure, when patients discharging the recovery room
Secondary outcome [2] 268604 0
Mallampati score used to predict the ease of intubation as assessed by clnical staff
Timepoint [2] 268604 0
Before anaesthetic induction
Secondary outcome [3] 268605 0
blood on laryngoscope will be assessed by clinical staff
Timepoint [3] 268605 0
after intubation
Secondary outcome [4] 268635 0
thyromental distance will be assessed by clinical staff
Timepoint [4] 268635 0
Before anaesthetic induction
Secondary outcome [5] 268636 0
Neck circumference will be assessed by clinical staff
Timepoint [5] 268636 0
Before anaesthetic induction
Secondary outcome [6] 268637 0
pulse oximetry value below 95% will be assessed by clinical staff
Timepoint [6] 268637 0
after intubation

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/10/2010
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] 3084 0
Korea, Republic Of
State/province [1] 3084 0

Funding & Sponsors
Funding source category [1] 258194 0
Self funded/Unfunded
Name [1] 258194 0
jie ae kim
Country [1] 258194 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] 257369 0
Individual
Name [1] 257369 0
Jin Kyung Kim
Address [1] 257369 0
Jin Kyung 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 [1] 257369 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260182 0
Samsung Medical Centre Human Research Ethics Committee
Ethics committee address [1] 260182 0
Samsung Medical Center, Sungkyunkwan University school of medicine, 50, Irwon-dong, Gangnam-gu, Seoul, Korea 135-710
Ethics committee country [1] 260182 0
Korea, Republic Of
Date submitted for ethics approval [1] 260182 0
Approval date [1] 260182 0
01/08/2010
Ethics approval number [1] 260182 0
2009-04-034

Summary
Brief summary
We hypothesized that intubation with Videolight wand laryngoscope in a simulated difficult airway using cervical collar could bring merits compared to Airway Scope due to its slender shape.After induction of anaesthesia and neck stabilisation, intubation with Airway Scope or Videolight wand will be tried in 100 patients. Overall success rate, time and trials for successful intubation, optimisation, intubation difficulty score, vital signs, and complications will be recorded and patients’ morphologic factors related to the intubation time will be analysed in each group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32005 0
Address 32005 0
Country 32005 0
Phone 32005 0
Fax 32005 0
Email 32005 0
Contact person for public queries
Name 15252 0
jie ae kim
Address 15252 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 15252 0
Korea, Republic Of
Phone 15252 0
+82 2 3410 2470
Fax 15252 0
Email 15252 0
[email protected]
Contact person for scientific queries
Name 6180 0
jie ae kim
Address 6180 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 6180 0
Korea, Republic Of
Phone 6180 0
+82 2 3410 2470
Fax 6180 0
Email 6180 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

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