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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: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2015/02/005589
Date of registration: 26-02-2015
Prospective Registration: No
Primary sponsor: Tata Memorial Hospital
Public title: Compare between McGrath videolaryngoscope and Macintosh laryngoscope for putting the tube into windpipe through nose in patients undergoing surgery for head and neck cancers
Scientific title: 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: 04-08-2014
Target sample size: 60
Recruitment status: Open to Recruitment
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11040
Study type:  Interventional
Study design:  Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label
 
Phase:  N/A
Countries of recruitment
India
Contacts
Name: Dr Reshma Ambulkar   
Address:  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: 919821790448
Email: rambulkar@hotmail.com
Affiliation:  Tata Memorial Centre
Name: Dr Reshma Ambulkar   
Address:  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: 919821790448
Email: rambulkar@hotmail.com
Affiliation:  Tata Memorial Centre
Key inclusion & exclusion criteria
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:
Health Condition(s) or Problem(s) studied
Health Condition 1: C229- Malignant neoplasm of liver, not specified as primary or secondary
Intervention(s)
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.
Primary Outcome(s)
To compare time taken for intubation using the two blades.Timepoint: Preoperatively for nasotracheal intubation
Secondary Outcome(s)
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
Secondary ID(s)
NIL
Source(s) of Monetary Support
Department of Anaesthesia Critical Care and Pain
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 24/01/2014
Contact:
Institutional Ethics Committee II
Results
Results available:
Date Posted:
Date Completed:
URL:
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