Main
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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:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616001098426 |
Date of registration:
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12/08/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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:
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05/08/2014 |
Target sample size:
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60 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12616001098426.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety;
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Phase:
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Not Applicable
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Countries of recruitment
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Bahrain
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Contacts
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Name:
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Dr Mahesh M Chandrashekaraiah
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Address:
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Registrar
King Hamad University Hospital
P O Box 24343 Road 2345 Area 228
Bahrain
Bahrain |
Telephone:
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+973174444250 |
Email:
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mahesh.c@khuh.org.bh |
Affiliation:
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Name:
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Dr Mahesh M Chandrashekaraiah
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Address:
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Registrar
King Hamad University Hospital
P O Box 24343 Road 2345 Area 228
Bahrain
Bahrain |
Telephone:
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+973174444250 |
Email:
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mahesh.c@khuh.org.bh |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Anaesthesiology - Anaesthetics
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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
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Intervention(s)
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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.
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Primary Outcome(s)
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Intubation Difficulty Scale Score[The IDS score will be recorded by the laryngoscopist after the successful intubation with apperance of ETCO2 tracings]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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NIL KNOWN
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Source(s) of Monetary Support
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Shahid Adeel
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Ethics review
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Status: Approved
Approval date:
Contact:
Research and Ethics CommitteeKing Hamad University Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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