Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000154404
Ethics application status
Approved
Date submitted
19/01/2016
Date registered
9/02/2016
Date last updated
9/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of C-MAC D-blade video laryngoscope with C-MAC and Macintosh laryngoscope: A randomised, controlled trial in patients with normal airways
Scientific title
Clinical evaluation of C-MAC D-blade videolaryngoscope. Randomised comparison to C-MAC and direct laryngoscopy in patients with normal airways
Secondary ID [1] 288352 0
Nil known
Universal Trial Number (UTN)
U1111-1144-6475
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Videolaryngoscopy during endotracheal intubation in patients with normal airways. 297337 0
Condition category
Condition code
Anaesthesiology 297536 297536 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We recruited 180 patients of ASA physical status 1-3 who were scheduled for elective surgery under general anaesthesia requiring endotracheal intubation.
After obtaining written informed consent, patients were assigned, by using a computer-generated randomisation code, to laryngoscopy with either C-MAC D-blade, C-MAC with Macintosh blade or Macintosh laryngoscope. All tracheal intubations were performed by anesthesiologists who had used all the devices more than 60 times in practice.
Standard monitoring devices were attached before induction of anaesthesia (pulse oximeter, 3-lead ECG and a non-invasive blood pressure cuff). After the pre-oxygenation with 100% oxygen in order to achieve end-tidal oxygen >80%,anesthesia was induced with intravenous sufentanil 0.2-0.3 µg.kg-1 and propofol 2-3 mg.kg-1. Rocuronium 0.6-0.9 mg.kg-1 was administered for neuromuscular blockade after confirmation of successful manual bag-mask ventilation with patients placed in „sniffing“ head position. A size 7.0 mm tracheal tube was used to intubate the trachea in female patients, and a size 7.5 mm tube was used for all male patients.
If more than one intubation attempt was required, the patient received bag-and mask ventilation between attempts and various manoeuvres were employed, including external laryngeal pressure, readjustment of the stylet and use of a bougie. Failure of the procedure was declared if intubation was not achieved within 120s, if more than three intubation attempts were required or if oxygen saturation dropped below 95%.. Intubation attempt was defined as commencing with placement of the device past the level of upper incisors (or upper lip if patient had no teeth) and similarly ending with removal of the device past the level of upper incisors(or upper lip if patient had no teeth). The failed attempt was subsequently managed at the discretion of the attending anaesthesiologist and the chosen technique was recorded. Correct placement of the tracheal tube was confirmed by capnography and bilateral chest auscultation.
Data were collected by one independent observer.
Intervention code [1] 293655 0
Treatment: Devices
Comparator / control treatment
Endotracheal intubation with Macintosh laryngoscope.
Control group
Active

Outcomes
Primary outcome [1] 297091 0
Total time to successful intubation. Intubation attempt is defined as commencing with placement of the device past the level of upper incisors (or upper lip if patient had no teeth) and similarly ending with removal of the device past the level of upper incisors (or upper lip if patient had no teeth) using end-tidal carbon dioxide (CO2) detected by capnography as confirmation of successful intubation.. Failure of the procedure is declared if intubation was not achieved within 120s, if more than three intubation attempts were required or if oxygen saturation dropped below 95%.
Timepoint [1] 297091 0
During intubation - From insertion of the allocated videolaryngoscope into the participants mouth until end-tidal carbon dioxide (CO2) detected by capnography.
Secondary outcome [1] 320007 0
Total time to optimal laryngeal view. Defined as commencing with placement of the device past the level of upper incisors (or upper lip if patient had no teeth) and ending when optimal laryngeal view obtained to start the intubation. Optimal laryngeal view is assessed using POGO score (percentage of glottic opening).
Timepoint [1] 320007 0
During intubation - From insertion of the allocated videolaryngoscope into the participants mouth until optimal laryngeal view obtained for starting the intubation.
Secondary outcome [2] 320008 0
Total time to tracheal tube insertion. Defined from the point when optimal laryngeal view is obtained to start the intubation and ending with removal of the device past the level of upper incisors (or upper lip if patient had no teeth) with confirmation of successful intubation using capnography.
Timepoint [2] 320008 0
During intubation - From point when optimal laryngeal view obtained for starting the intubation until removal of the device past the level of upper incisors (or upper lip if patient had no teeth) with confirmation of successful intubation using capnography.
Secondary outcome [3] 320009 0
Difficulty of intubation assessed using 100 mm visual analogue scale (VAS)
Timepoint [3] 320009 0
After completion of endo tracheal intubation.
Secondary outcome [4] 320010 0
Difficulty of intubation assessed using intubation difficulty score (IDS), a seven point scoring system and Fremantle score
Timepoint [4] 320010 0
After completion of endo tracheal intubation.
Secondary outcome [5] 320011 0
Hemodynamic effect assessed using non-invasive blood pressure monitoring and pulse oximetry
Timepoint [5] 320011 0
5 min before, during and 5 min after commencement of intervention
Secondary outcome [6] 320045 0
Quality of laryngeal view assessed using Cormack and Lehane classification and POGO score (percentage of glottic opening)
Timepoint [6] 320045 0
After completion of endo tracheal intubation.

Eligibility
Key inclusion criteria
patients with normal airway set for general anaesthesia with endotracheal intubation needed
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
history of known difficult airway, non-fasting, ASA status IV and above, known airway pathology

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary endpoint of the study is time to successful tracheal intubation. A power analysis in order to determine sample size needed was conducted. Based on standard deviation of time to successful intubation of 17.6 s, analysis indicated a sample size of 56 patients in each group would provide 80% power and 5% level of significance to detect 30% difference between devices using one-way ANOVA. A decision was made to recruit 60 patients per group to allow dropouts. This is a parallel way three group study. SPSS v20 is going to be used to analyse the data: Kruskal-Wallis test for ordinal data, Chi-square test for nominal data and one-way ANOVA for continuous data. When significant differences will be encountered, post hoc pair-wise comparison will be performed. A value of p<0.05 is considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/07/2013
Date of last participant enrolment
Anticipated
Actual
19/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
180
Recruitment outside Australia
Country [1] 7538 0
Croatia
State/province [1] 7538 0
The city of Zagreb

Funding & Sponsors
Funding source category [1] 292709 0
Hospital
Name [1] 292709 0
University Clinical Hospital Sestre milosrdnice
Country [1] 292709 0
Croatia
Primary sponsor type
Hospital
Name
University Clinical Hospital Sestre milosrdnice
Address
Vinogradska cesta 29
10000 Zagreb
Croatia
Country
Croatia
Secondary sponsor category [1] 291443 0
None
Name [1] 291443 0
none
Address [1] 291443 0
none
Country [1] 291443 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294196 0
University Clinical Hospital Sestre milosrdnice ethical board
Ethics committee address [1] 294196 0
Ethics committee country [1] 294196 0
Croatia
Date submitted for ethics approval [1] 294196 0
01/07/2013
Approval date [1] 294196 0
11/07/2013
Ethics approval number [1] 294196 0
EP-11810/13-4

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

Contacts
Principal investigator
Name 62810 0
Dr Vedran Hostic
Address 62810 0
KBC Sestre milosrdnice, Vinogradska cesta 29, 10000 Zagreb, Croatia
Country 62810 0
Croatia
Phone 62810 0
+385912554054
Fax 62810 0
Email 62810 0
[email protected]
Contact person for public queries
Name 62811 0
Vedran Hostic
Address 62811 0
KBC Sestre milosrdnice, Vinogradska cesta 29, 10000 Zagreb
Country 62811 0
Croatia
Phone 62811 0
+385912554054
Fax 62811 0
Email 62811 0
[email protected]
Contact person for scientific queries
Name 62812 0
Vedran Hostic
Address 62812 0
KBC Sestre milosrdnice, Vinogradska cesta 29, 10000 Zagreb
Country 62812 0
Croatia
Phone 62812 0
+385912554054
Fax 62812 0
Email 62812 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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