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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12616001098426
Date of registration: 12/08/2016
Prospective Registration: No
Primary sponsor: Shahid Adeel
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.
Date of first enrolment: 05/08/2014
Target sample size: 60
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12616001098426.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety;  
Phase:  Not Applicable
Countries of recruitment
Bahrain
Contacts
Name: Dr Mahesh M Chandrashekaraiah   
Address:  Registrar King Hamad University Hospital P O Box 24343 Road 2345 Area 228 Bahrain Bahrain
Telephone: +973174444250
Email: mahesh.c@khuh.org.bh
Affiliation: 
Name: Dr Mahesh M Chandrashekaraiah   
Address:  Registrar King Hamad University Hospital P O Box 24343 Road 2345 Area 228 Bahrain Bahrain
Telephone: +973174444250
Email: mahesh.c@khuh.org.bh
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: patients undergoing general elective surgery requiring general anesthesia with endotracheal intubation
ASA class 1 &2
no predictors of difficult airway

Exclusion criteria: Predictors of difficult airway
Chest diseases,
Emergency cases
previuos Neck surgery


Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Anaesthesiology - Anaesthetics
Airway management;Manual inline axial stabilisation on non-difficult airway;Patients coming for elective surgery;
Airway management
Manual inline axial stabilisation on non-difficult airway
Patients coming for elective surgery
Intervention(s)
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.
Primary Outcome(s)
Intubation Difficulty Scale Score[The IDS score will be recorded by the laryngoscopist after the successful intubation with apperance of ETCO2 tracings]
Secondary Outcome(s)
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 [recorded at pre induction, pre intubation , post intubation and 3 minutes post intubation]
Secondary ID(s)
NIL KNOWN
Source(s) of Monetary Support
Shahid Adeel
Secondary Sponsor(s)
MAHESH CHANDRASHEKARAIAH
Ethics review
Status: Approved
Approval date:
Contact:
Research and Ethics CommitteeKing Hamad University Hospital
Results
Results available:
Date Posted:
Date Completed:
URL:
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