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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CTRI |
Last refreshed on:
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24 November 2021 |
Main ID: |
CTRI/2015/02/005589 |
Date of registration:
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26-02-2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Compare between McGrath videolaryngoscope and Macintosh laryngoscope for putting the tube into windpipe through nose in patients undergoing
surgery for head and neck cancers
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Scientific title:
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A randomized trial comparing the McGrath videolaryngoscope with the
Macintosh laryngoscope for nasotracheal intubation in patients undergoing
surgery for head and neck malignancies |
Date of first enrolment:
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04-08-2014 |
Target sample size:
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60 |
Recruitment status: |
Open to Recruitment |
URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11040 |
Study type:
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Interventional |
Study design:
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Randomized, Parallel Group Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Reshma Ambulkar
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Address:
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Tata Memorial Centre Dr E. Borges Road Parel, Mumbai
Dr. E.Borges Road Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India Tata Memorial Centre Dr E. Borges Road Parel, Mumbai
Dr. E.Borges Road Parel, Mumbai
400012
South, MAHARASHTRA
India |
Telephone:
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919821790448 |
Email:
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rambulkar@hotmail.com |
Affiliation:
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Tata Memorial Centre |
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Name:
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Dr Reshma Ambulkar
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Address:
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Tata Memorial Centre Dr E. Borges Road Parel, Mumbai
Dr. E.Borges Road Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India Tata Memorial Centre Dr E. Borges Road Parel, Mumbai
Dr. E.Borges Road Parel, Mumbai
400012
South, MAHARASHTRA
India |
Telephone:
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919821790448 |
Email:
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rambulkar@hotmail.com |
Affiliation:
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Tata Memorial Centre |
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Key inclusion & exclusion criteria
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Inclusion criteria: •Adult patients (18 years and above).
•ASA status I â?? II
•Undergoing elective surgery for malignancies of the head and neck
•Who will need nasotracheal intubation.
Exclusion criteria: •Refusal of consent
•Risk factors for gastric aspiration present
•All patients with a previously documented difficult tracheal intubation
•Previous head and neck surgery
•Anticipated difficult airway where standard induction of general anaesthesia (intravenous induction with non-depolarizing muscle relaxant) is not planned.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: C229- Malignant neoplasm of liver, not specified as primary or secondary
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Intervention(s)
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Intervention1: McGrath videolaryngoscope: The McGrath videolaryngoscope has a small LCD screen, a single choice of blade (with three different length settings), and an acrylic cover with a 60 degree angulation to provide an indirect view of the glottis. Control Intervention1: Macintosh laryngoscope: In patients whose airway is not predicted to be difficult pre-operatively, the standard technique of intubation is to use a Macintosh laryngoscope to visualize the glottic opening and to guide the nasotracheal tube into the glottis using Magills forceps.
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Primary Outcome(s)
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To compare time taken for intubation using the two blades.Timepoint: Preoperatively for nasotracheal intubation
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Secondary Outcome(s)
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â?¢To compare success rates for intubation in the two groups of patients.
â?¢To compare difficulty level during intubation using Adnet scale
Timepoint: Preoperatively for nasotracheal intubation
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Source(s) of Monetary Support
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Department of Anaesthesia Critical Care and Pain
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Ethics review
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Status: Approved
Approval date: 24/01/2014
Contact:
Institutional Ethics Committee II
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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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