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CTRI Number  CTRI/2025/03/082057 [Registered on: 10/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A comparative analysis of neck movement during endotracheal intubation using different laryngoscopes: An inclinometer based study- a prospective observational clinical trial 
Scientific Title of Study   A Comparative study of the Effects of Different Types of Laryngoscopes on the Cervical spine Motion using an inclinometer : Randomised clinical trial. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mukesh R 
Designation  Senior Resident  
Affiliation  Nizam’s Institute of Medical Sciences  
Address  Department of Anesthesiology,Old Block, Nizam’s Institute of Medical Sciences , Punjagutta Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  9177679736  
Fax    
Email  mukeshnayak2409@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Akhya Kumar Kar 
Designation  Associate Professor in Department of Anaesthesiology  
Affiliation  Nizams Institute of Medical Sciences 
Address  Department of Anesthesiology, Old Block,Nizams Institute of Medical sciences,Punjagutta, Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  8143385838  
Fax    
Email  karakshay@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mukesh R 
Designation  Seniors Resident  
Affiliation  Nizams institute of medical sciences 
Address  Department of Anaesthesiology Old block, first floor , Punjagutta

Hyderabad
TELANGANA
500082
India 
Phone  9177679736  
Fax    
Email  mukeshnayak2409@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, Nizams Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana,500082 
 
Primary Sponsor  
Name  Nizams Institute of Medical Sciences  
Address  Department of Anaesthesiology,Nizams Institute of Medical Sciences, Punjagutta , Hyderabad , Telangana ,500082  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Mukesh  Nizams Institute of Medical Sciences   Speciality Block Operation Theatre ,Department of Anaesthesiology,Nizams Institute of Medical Sciences
Hyderabad
TELANGANA 
9177679736

mukeshnayak2409@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  C-MAC Videolaryngoscope  Cervical spine motion will be measured using inclinometer during mask ventilation, intubation with C mac videolaryngoscope.study will end after the position of endotracheal tube is confirmed. 
Comparator Agent  Laryngoscopy  Cervical spine motion will be measured using inclinometer during mask ventilation, intubation with BPL videolaryngoscope. study will end after the position of endotracheal tube is confirmed. 
Comparator Agent  McGrath Videolaryngoscope   Cervical spine motion will be measured using inclinometer during mask ventilation, intubation with Mcgrath videolaryngoscope. study will end after the position of endotracheal tube is confirmed. 
Comparator Agent  McIntosh laryngoscope   Cervical spine motion will be measured using inclinometer during mask ventilation, intubation with Mc Intosh laryngoscope.study will end after the position of endotracheal tube is confirmed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Written valid consent, ASA 1-2, Age 18-65 yrs, Mallampati grade 1-2 
 
ExclusionCriteria 
Details  BMI more than 30, predicted difficult airway, previous neck surgery or abnormal airway morphology, clinical and radiographic suspicion of cervical spine abnormality, mouth opening less than 2 fingers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the degree of cervical spine motion indirectly measured
through an inclinometer at best glottic view during intubation with different laryngoscopes. 
At neutral position and during best glottic view. study will end after the position of endotracheal tube is confirmed. this will be around 10-15 mins after induction of general anaesthesia.  
 
Secondary Outcome  
Outcome  TimePoints 
to compare the degree of cervical spine motion during successful
mask ventilation, 
During mask ventilation immediately after induction of general anaesthesia. 
the incidence of difficult endotracheal tube insertion at the best glottic
view 
At best glottic view during laryngoscopy immediately after performing laryngoscopy to visualise glottis for endotracheal intubation. 
Intubation Difficulty Score in different laryngoscopes  Immediately after intubation with endotracheal tube  
To compare duration of intubation with different laryngoscopes  immediately after successful endotracheal intubation 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mukeshnayak2409@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Study patients are adults undergoing elective surgery under
general anaesthesia requiring endotracheal intubation. The enrolled patients will be divided in
to four groups Group-1,2,3,4 in which patients will be intubated with mc-intosh
Laryngoscope, cmac, mcgrath, BPL respectively. Patients will be allocated to specific group
through random number generated through computer in a sealed envelopes technique.
Routine preoperative anaesthetic check up and optimization, if needed will be done.
Once patients will be taken into the operation theater, standard preinduction monitors such as
electrocardiograms, pulse oximetry, non-invasive BP monitoring.
Intravenous access will be obtained with a 18G or 20G cannula
under strict aseptic conditions .Now patient made to supine
position and preoxygenation is done with 100% oxygen for 3
minutes. All patients will receive glycopyrrolate (1µg/kg body
weight), fentanyl (2 µg/kg) as premedication. Following which
patient will be given induction with propofol and inhalational
agent. Each patient lay supine on a flat level operating table, the
inclinometer is placed on forehead and neck straightened till it is
horizontal to the floor . Standard mask ventilation procedure will
be followed with 2 hand technique. Intubation will be attempted
with laryngoscopes allotted in each group with as minimal neck
movement as possible. . Inclinometer angle will be measured at
five points 1. At neutral before induction, 2. Before mask
ventilation, 3. At point of successful mask ventilation, 4. Best
glottic view, 5. At the pot of et insertion. Also hans scale for mask
ventilation, CL grading, and Intubation Difficulty Scale (IDS)
scores were assessed and recorded for all patients.Therefore,
neutral position was applied to the head before the laryngoscopy.
In this procedure, the head was stabilized as the infraorbital edge
and tragus is perpendicular to the ground.An inclinometer (a 360
degree angle gauge) was placed on the forehead of the patients, so
that the tip of the inclinometer fit the glabellar line The inner
diameters of the intubation tubes used for females and males were
7 to 7.5 mm and 8 to 8.5 mm, respectively(2). The maximum angle of
cervical extension was measured by an inclinometer. The head was
neutrally positioned and the degree that the inclinometer showed
was recorded. Then, the maximum degree shown by the inclinometer
during laryngoscopy and tracheal intubation was recorded. The
maximum angle of cervical extension was measured by subtracting
the first and last recorded degree(2). An IDS score (3) of IDS 0
=(easy intubation) IDS 1 to 5 suggests (slight difficulty), and IDS
≥5 denotes a (difficult intubation).The duration from the
laryngoscope blade passing the lips and the placement of the tube
into trachea is recorded as the intubation process time (IPT).If the
IPT was more than 120 seconds, the patients will be ventilated for 1
minute with a face mask, and then intubation will be performed
using a fiberoptic laryngoscope for unsuccessful ones(2) . Those
patients will be excluded from the study. Finally, all of the
patients will be intubated.
 
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