Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000910606
Ethics application status
Approved
Date submitted
29/07/2014
Date registered
26/08/2014
Date last updated
26/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of McGrath Series 5 video laryngoscope with Macintosh laryngoscope: A randomised, controlled trial in patients with normal airways
Scientific title
Comparison of McGrath Series 5 video laryngoscope with Macintosh laryngoscope: A randomised, controlled trial in patients with normal airways
Secondary ID [1] 285071 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tracheal intubation to patients with normal airways. 292601 0
Condition category
Condition code
Anaesthesiology 292909 292909 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We recruited 100 patients of ASA physical status 1-2 who were scheduled for elective surgery under general anaesthesia requiring tracheal intubation.
After obtaining written informed consent, patients were assigned, by using a computer-generated block randomisation, to laryngoscopy with either McGrath videolaryngoscope or the Macintosh laryngoscope. All tracheal intubations with both the Macintosh laryngoscope and McGrath videolaryngoscope were performed by one anesthesiologist who had used both devices more than 50 times clinically.
All patients were expected to fast 6-8 hours before surgery, and no one premedicated. With the patient placed in the supine position, routine monitors (consisting of a pulse oximeter, 3-lead ECG and a non-invasive blood pressure cuff) were applied. Baseline measurements were obtained and 3 min of pre-oxygenation was performed before the induction of general anaesthesia. Standardised anesthetic induction was preformed with 1 mcg/kg fentanyl, 1-2 mg/kg of propofol, and when consciousness was lost, 0.6 mg/kg of rocuronium was injected. After, making sure that all four TOF responses of the Adductor Pollicis disappeared, which ensures sufficient musclular blockade, intubation was then performed. Number 3 or 4 blades was used in all patients. 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. Failed intubation was defined as failure after three attempts and a pre-determined alternative airway management plan was instituted by the treating anaesthetist. Correct placement of the tracheal tube was confirmed by capnography and bilateral chest auscultation.
Data were collected by one independent observer. The time taken for successful tracheal intubation was measured from the time the allocated laryngoscope was inserted in the patient’s mouth until end-tidal carbon dioxide was detected.
The difference between The McGrath videolaryngoscope with the Macintosh laryngoscope is to obtain laryngoscopic view with the help of a monitor.
Intervention code [1] 289910 0
Treatment: Devices
Comparator / control treatment
Intubation with Macintosh laryngoscope.
Control group
Active

Outcomes
Primary outcome [1] 292777 0
The primary outcome was the laryngoscopy view using percentage of glottic opening (POGO) score (0 to 100%, 100 = full view of glottis from anterior commissure to the inter-arytenoid notch, 0 = even inter-arytenoid notch is not seen).
Timepoint [1] 292777 0
During intubation, 0 to 100%, 100 = full view of glottis from anterior commissure to the inter-arytenoid notch, 0 = even inter-arytenoid notch is not seen.
Secondary outcome [1] 309662 0
Time for successful intubation or until alternative management selected. Alternative management will be decided after failed attempt with the allocated device. Failed attempt is defined as more than three intubation attempts.
Timepoint [1] 309662 0
During intubation - From insertion of the allocated videolaryngoscope into the participants mouth until end-tidal carbon dioxide (CO2) detected by capnography.
Secondary outcome [2] 309663 0
Comparison of the laryngoscopy view using the Cormack and Lehane
grading system (Grade I to IV). This is assessed by the anaesthetist performing the intubation, the view is seen during intubation.
Timepoint [2] 309663 0
During intubation, when best laryngoscopic view is obtained with the allocated device.
Secondary outcome [3] 309664 0
Number of attempts needed for successful intubation
Timepoint [3] 309664 0
Recorded during the intubation attempt
Secondary outcome [4] 309665 0
Haemodynamic changes (blood pressure, heart rate) during intubation. This is assessed by the independent observer, using the patient vital record on the monitor ( blood pressure measured by automatic sphygmomanometer, heart rate measured by ECG)
Timepoint [4] 309665 0
At baseline, at immediately after intubation and 5 minutes after successful intubation.
Secondary outcome [5] 309666 0
Any complications associated with oro-tracheal intubation, such as, , injury to lips, oral mucosal or dentition, oesophageal intubation, or hypoxia (SpO2 < 90%).
Timepoint [5] 309666 0
During and/or after intubation

Eligibility
Key inclusion criteria
Scheduled for elective surgery under general anaesthesia requiring tracheal intubation.
Airway difficulty score (ADS) under 8 points.
Amarican Society of Anesthesiology (ASA) physical status I-II.
Over 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with an ADS score above 8 and thyroid-to-chin length of 5 cm or shorter, a Mallampati class 3 or higher, mouth opening less than 3cm, restriction in neck extension or protruding front teeth were predicted to be difficult in intubation and were thus excluded from the study. Also, patients were excluded from the study if they required rapid sequence induction, had a history of previous difficult direct laryngoscopy and had uncontrolled hypertension, ischaemic heart disease, acute or recent stroke or myocardial infarction, cervical spine instability or cervical myelopathy, symptomatic asthma or reactive airway disease and history of gastric reflux.

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)
Patient information from the Hospital pre-admission clinic is reviewed, looking for patients that fit the inclusion criteria. If it seems that they will fall into the inclusion criteria, one of the researchers will approach the patient and explain the trial before gaining informed consent.
Using a computer program, the patient’s number will be randomly allocated into either the McGrath Videolaryngoscope group or the C-MAC Videolaryngoscope group. Allocation was concealed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is by using a computer-generated block randomization method.
Allocation was concealed by central randomisation by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2014
Actual
15/07/2014
Date of last participant enrolment
Anticipated
Actual
2/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6258 0
Turkey
State/province [1] 6258 0
Konya

Funding & Sponsors
Funding source category [1] 289679 0
Hospital
Name [1] 289679 0
Konya Training and Research Hospital
Country [1] 289679 0
Turkey
Primary sponsor type
Hospital
Name
Konya Training and Research Hospital
Address
Konya Training and Research Hospital, Meram-Konya

Postcode:42090
Country
Turkey
Secondary sponsor category [1] 288372 0
None
Name [1] 288372 0
Address [1] 288372 0
Country [1] 288372 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291414 0
Necmettin Erbakan University Meram School of Medicine
Ethics committee address [1] 291414 0
Ethics committee country [1] 291414 0
Turkey
Date submitted for ethics approval [1] 291414 0
20/06/2014
Approval date [1] 291414 0
04/07/2014
Ethics approval number [1] 291414 0
2014.89

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

Contacts
Principal investigator
Name 50274 0
Dr Mehmet SARGIN
Address 50274 0
Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Meram, Konya

Postcode:42090
Country 50274 0
Turkey
Phone 50274 0
+905322662766
Fax 50274 0
Email 50274 0
[email protected]
Contact person for public queries
Name 50275 0
Sadik OZMEN
Address 50275 0
Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Meram, Konya

Postcode:42090
Country 50275 0
Turkey
Phone 50275 0
+903322212250
Fax 50275 0
Email 50275 0
[email protected]
Contact person for scientific queries
Name 50276 0
Sadik OZMEN
Address 50276 0
Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Meram, Konya

Postcode:42090
Country 50276 0
Turkey
Phone 50276 0
+903322212250
Fax 50276 0
Email 50276 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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