Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001098426
Ethics application status
Approved
Date submitted
17/07/2016
Date registered
12/08/2016
Date last updated
24/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Ease of Intubation using C-MAC Vs Macintosh Laryngoscope in Patients with the Application of Manual Inline Axial Stabilization - A Randomized Comparative Study
Scientific title
Evaluation of the ease of intubation using C-MAC Vs Macintosh Laryngoscope in patients with the application of manual inline axial stabilisation - A randomised trial.
Secondary ID [1] 286107 0
NIL KNOWN
Universal Trial Number (UTN)
WHO UTN U1111-1157-7018
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway management 299510 0
Manual inline axial stabilisation on non-difficult airway 299511 0
Patients coming for elective surgery 299512 0
Condition category
Condition code
Anaesthesiology 299489 299489 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CMAC video laryngoscope is having same conventional Macintosh Laryngoscope blade, but with a camera. Essentially it will be indirect view in contrast to direct view by Macintosh Laryngoscope. The laryngoscopy will be done by single experienced( in CMAC) anesthetist of consultant grade
Intubation difficulty scale score is recorded . Which reaches higher score if there is change in hands, device or technique. Failed intubation in one technique yield infinite score ( as per Intubation difficiculty scale scoring, 0: difficulty,8 (infinite): impossible to intubate) )and suitable alternative will be employed in securing intubation or ventilation.
Manual In line Axial Stabilisation(MIAS) is essentially proven step in preventing the further damage in C-spine injury . A trained anesthetist will be employing MIAS manouvere before intubation attempts.Essentially MIAS involves a trained person stabilizing the head and neck by crouching beside the intubator with hands placed on the patient’s mastoid processes or cradling the occiput giving sufficient counter pressure to prevent neck movements during laryngoscopy.
Intervention code [1] 295324 0
Treatment: Devices
Comparator / control treatment
Conventional Macintosh Laryngoscope gives a direct view of glottis in contrast to indirect view of glottis in CMAC on video screen. MIAS will be used in our comparator group. As we are simulating difficult airway in both the groups.
Control group
Active

Outcomes
Primary outcome [1] 298966 0
Intubation Difficulty Scale Score
Timepoint [1] 298966 0
The IDS score will be recorded by the laryngoscopist after the successful intubation with apperance of ETCO2 tracings
Secondary outcome [1] 325770 0
Composite Outcome
Hemodynamic parameters Heart rate, Systolic blood pressure, Diastolic pressure and Mean arterial pressure.
The above-said variables are measured using multiparameter which has Pulse oximetry, Non invasive automated bloodpressure, ECG
Timepoint [1] 325770 0
recorded at pre induction, pre intubation , post intubation and 3 minutes post intubation

Eligibility
Key inclusion criteria
patients undergoing general elective surgery requiring general anesthesia with endotracheal intubation
ASA class 1 &2
no predictors of difficult airway
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Predictors of difficult airway
Chest diseases,
Emergency cases
previuos Neck surgery

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)
Central Randomisation by computer ( www.randomisation .com)
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


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The Study sample was calculated using data from previous studies of similar Kind
power study-80% , alpha error 5%
Student t test, Chi-square test ANOVA, Fischer exact test

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/08/2014
Date of last participant enrolment
Anticipated
Actual
16/04/2015
Date of last data collection
Anticipated
16/04/2015
Actual
16/04/2015
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 8035 0
Bahrain
State/province [1] 8035 0
Bahrain

Funding & Sponsors
Funding source category [1] 294078 0
Self funded/Unfunded
Name [1] 294078 0
Shahid Adeel
Country [1] 294078 0
Bahrain
Primary sponsor type
Individual
Name
Shahid Adeel
Address
Consultant Anesthesia and ICU
King Hamad University Hospital, Building 2345, Road 2835, Block 228, Busaiteen,
P. O. Box 24343, Kingdom of Bahrain
Country
Bahrain
Secondary sponsor category [1] 292908 0
Individual
Name [1] 292908 0
MAHESH CHANDRASHEKARAIAH
Address [1] 292908 0
King Hamad University Hospital, Building 2345, Road 2835, Block 228, Busaiteen,
P. O. Box 24343, Kingdom of Bahrain
Country [1] 292908 0
Bahrain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295492 0
Research and Ethics CommitteeKing Hamad University Hospital
Ethics committee address [1] 295492 0
King Hamad University Hospital
po box 24343, area 228 road 2345
Ethics committee country [1] 295492 0
Bahrain
Date submitted for ethics approval [1] 295492 0
13/05/2014
Approval date [1] 295492 0
15/07/2014
Ethics approval number [1] 295492 0
Ref. KHUH/Research/No. 51/2014

Summary
Brief summary
Airway management in cervical spine injury is complicated ,as the established way of achieving the airway controlby direct laryngoscopy using Macintosh laryngoscope will have distracting injuries on the cervical cord, if there is unstable cervical spine injury. In these cases , it is proven that application of manual in line axial stabilisation (MIAS) will counteract the forces of direct laryngoscopy and reduce the further damage. At the same time MIAS create significant difficulty for laryngoscopy. The idea behind this study was to verify whether simulated difficult airway scenarios , as created in our study by application of MIAS manouvere can be optimally managed with videolaryngoscopy in comparison to conventional direct laryngoscopy
Trial website
Trial related presentations / publications
M M Chandrashekaraiah, V H Shah,V C Pandey,S Adeel.Evaluation of ease of intubation using C-MAC vs Macintosh laryngoscope in patients with the application of manual inline axial stabilization - A randomized comparative study.Sri Lankan Journal of Anaesthesiology: 25(1):8-12(2017) DOI: 10.4038/slja.v25i1.8169
Public notes
Attachments [1] 963 963 0 0
/AnzctrAttachments/367901-ethics committee Letter - Dr Shahid adeel.docx
Attachments [2] 1534 1534 0 0
/AnzctrAttachments/367901-CMAC vs Mc intosh.pdf (Publication)

Contacts
Principal investigator
Name 54662 0
Dr Shahid Adeel
Address 54662 0
Consultant Anesthesia and Pain Medicine
King Hamad University Hospital
P O Box 24343 Road 2345 Area 228
Bahrain
Country 54662 0
Bahrain
Phone 54662 0
+97317444258
Fax 54662 0
Email 54662 0
shahid.adeel@khuh.org.bh
Contact person for public queries
Name 54663 0
Dr Mahesh M Chandrashekaraiah
Address 54663 0
Registrar
King Hamad University Hospital
P O Box 24343 Road 2345 Area 228
Bahrain
Country 54663 0
Bahrain
Phone 54663 0
+973174444250
Fax 54663 0
Email 54663 0
mahesh.c@khuh.org.bh
Contact person for scientific queries
Name 54664 0
Dr Mahesh M Chandrashekaraiah
Address 54664 0
Registrar
King Hamad University Hospital
P O Box 24343 Road 2345 Area 228
Bahrain
Country 54664 0
Bahrain
Phone 54664 0
+973174444250
Fax 54664 0
Email 54664 0
mahesh.c@khuh.org.bh

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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