Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000609651
Ethics application status
Approved
Date submitted
23/05/2014
Date registered
6/06/2014
Date last updated
24/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the Macintosh laryngoscope vs KingVision videolaryngoscope for routine tracheal intubation
Scientific title
Comparison of the Macintosh laryngoscope vs KingVision videolaryngoscope for routine tracheal intubation in Asian female surgical patients without predictors of difficult airway
Secondary ID [1] 284646 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Performance of airway device

 291961 0
Paralyzed and intubated patients for surgery without predictors of a difficult airway 291962 0
Condition category
Condition code
Anaesthesiology 292313 292313 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After induction of a standard general anaesthetic and 3 min after administration of a neuromuscular blocking agent, patients underwent indirect laryngoscopy and intubation with the KingVision videolaryngoscope (comprising a reusable 2.4inch video display screen and disposable blades).
Intervention code [1] 289430 0
Treatment: Devices
Comparator / control treatment
After induction of a standard general anaesthetic and 3 min after administration of a neuromuscular blocking agent, patients underwent conventional direct laryngoscopy and intubation with the classic Macintosh laryngoscope, which does not feature a video screen.
Control group
Active

Outcomes
Primary outcome [1] 292178 0
The primary endpoint is time to successful tracheal intubation. This is the interval from insertion of the laryngoscope blade into the mouth to when the tracheal tube cuff is inflated after successful intubation.
Timepoint [1] 292178 0
After the laryngoscope has been inserted into the participant's mouth.
Secondary outcome [1] 308369 0
Successful intubation on first attempt
Timepoint [1] 308369 0
When the laryngoscope has been inserted into the participant's mouth.
Secondary outcome [2] 308370 0
The intubation difficulty score (IDS) [the sum of 7 variables: number of intubation attempts, operators, use of alternative intubation techniques, glottic exposure, magnitude of lifting force required during laryngoscopy,need for external laryngeal pressure , and position of the vocal cords at intubation ]
Timepoint [2] 308370 0
At point of intubation of patient's trachea.
Secondary outcome [3] 308371 0
Ease of blade and tracheal tube insertion (subjectively assessed from 0: easy, to 100:difficult)
Timepoint [3] 308371 0
At point of intubation of patient's trachea.
Secondary outcome [4] 308372 0
The quality of the view (subjectively assessed from 0: good, 100: bad)
Timepoint [4] 308372 0
At point of intubation of patient's trachea
Secondary outcome [5] 308373 0
Optimization manoeuvres (repositioning of the patient’s head, use of external laryngeal pressure, further advancement or withdrawal of the laryngoscope blade, increased or decreased lifting force of the laryngoscope handle) and use of airway adjuncts (stylet, bougie) to aid intubation
Timepoint [5] 308373 0
At point of intubation of patient's trachea
Secondary outcome [6] 308374 0
Complications associated with tracheal intubation eg. desaturation (SpO2 <95%), oesophageal intubation, laryngo-pharyngeal morbidity ie. visible lip or dental injury, mucosal injury ( blood on laryngoscope blade).
Timepoint [6] 308374 0
At point of intubation of patient's trachea. An independent observer not involved in the trial assessed these outcomes.
Secondary outcome [7] 308375 0
Postoperative sorethroat (Yes/No)
Timepoint [7] 308375 0
Assessed in the PACU (post anaesthesia care unit) forty- five minutes after surgery by an independent observer.

Eligibility
Key inclusion criteria
Asian patients with normal airway parameters (eg. Mallampati 1-2, thyromental distance greater than or equal to 6.5 cm, sternomental distance greater than or equal to 12.5cm, interincisor distance greater than or equal to 4cm, ability to prognath, and normal head/neck movement) scheduled for gynaecological, breast or plastic reconstructive surgery at our women’s hospital.
Minimum age
22 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with previously documented difficult tracheal intubation, the morbidly obese (BMI > 40), those with a hiatus hernia, suffering symptomatic gastroesophageal reflux, and those at high risk of regurgitation or aspiration.

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)
Eligible participants were interviewed and invited to participate. Sealed, opaque envelopes concealed the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary end-point was time to successful tracheal intubation.Sample size calculation was based on a previous study that compared videolaryngoscope intubations with that of the intubating laryngeal mask in patients with normal airways. Power analysis showed that in order to show a difference of more than 50% in both groups with 80% power at 0.05 level of significance, 24 patients were needed in each group. 30 patients in each arm will be recruited to account for dropouts.

Data are reported as mean (SD), medians [range] and incidences (both absolute and percentage). The normal distribution of data was tested using the Kolmogorov-Smirnov test. Student’s t-test to analyze patient demographics and parametric data. The Mann-Whitney U-test was used to compare ASA status, Mallampati scores, ease of insertion/intubation, number of attempts needed between the two groups. Fisher’s exact test was used for comparison of side effects, and general linear model for repeated measures for haemodynamic variables. All statistical analyses were performed using SPSS 20.0 (SPSS, IBM Chicago, IL). P <0.05 was considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/06/2014
Actual
10/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6066 0
Singapore
State/province [1] 6066 0

Funding & Sponsors
Funding source category [1] 289271 0
Self funded/Unfunded
Name [1] 289271 0
Dr Wendy H.L. Teoh
Country [1] 289271 0
Singapore
Primary sponsor type
Individual
Name
Dr Wendy H.L. Teoh
Address
KK Women’s and Children’s Hospital,
100 Bukit Timah Road, Singapore 229899
Country
Singapore
Secondary sponsor category [1] 287945 0
None
Name [1] 287945 0
Address [1] 287945 0
Country [1] 287945 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291042 0
Singhealth Centralised Institutional Review Board D
Ethics committee address [1] 291042 0
Ethics committee country [1] 291042 0
Singapore
Date submitted for ethics approval [1] 291042 0
Approval date [1] 291042 0
22/05/2014
Ethics approval number [1] 291042 0
CIRB 2014-324-D

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

Contacts
Principal investigator
Name 48606 0
Dr Wendy H.L Teoh
Address 48606 0
Department of Women’s Anaesthesia,
KK Women’s and Children’s Hospital,
100 Bukit Timah Road. Singapore 229899.
Country 48606 0
Singapore
Phone 48606 0
+65- 63941081
Fax 48606 0
+65- 62912661
Email 48606 0
[email protected]
Contact person for public queries
Name 48607 0
Wendy H.L Teoh
Address 48607 0
Department of Women’s Anaesthesia,
KK Women’s and Children’s Hospital,
100 Bukit Timah Road, Singapore 229899.
Country 48607 0
Singapore
Phone 48607 0
+65- 63941081
Fax 48607 0
+65- 62912661
Email 48607 0
[email protected]
Contact person for scientific queries
Name 48608 0
Wendy H.L Teoh
Address 48608 0
Department of Women’s Anaesthesia,
KK Women’s and Children’s Hospital,
100 Bukit Timah Road Singapore 229899.
Country 48608 0
Singapore
Phone 48608 0
+65- 63941081
Fax 48608 0
+65- 62912661
Email 48608 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
No additional documents have been identified.