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CTRI Number  CTRI/2017/10/010157 [Registered on: 23/10/2017] Trial Registered Retrospectively
Last Modified On: 18/12/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Heart rate and blood pressure responses to laryngoscopy and tracheal intubation using two laryngoscopes in cervical spine injury patients 
Scientific Title of Study   Comparison of hemodynamic responses to laryngoscopy and tracheal intubation using Macintosh and AirtraQ® laryngoscope in patients with simulated cervical spine injury  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nithin Mathew 
Designation  Junior Resident 
Affiliation  Kasturba Medical College , Manipal 
Address  Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  nibithan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogesh K Gaude 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College , Manipal 
Address  Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  yogeshgaude@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Yogesh K Gaude 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College , Manipal 
Address  Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  yogeshgaude@gmail.com  
 
Source of Monetary or Material Support  
PG thesis fund, Manipal University, Manipal 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Nithin Mathew  Kasturba Hospital  Department of Anaesthesiology. OT Complex,Manipal University, Madhavnagr, Manipal
Udupi
KARNATAKA 
7259616541

nibithan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Hospital, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  American Society of Anaesthesiology physical status 1 and 2,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AirtraQ® laryngoscope  Group A: AirtraQ® laryngoscope size 3 (Regular) for 7.0 – 8.5ID ET tubes and size2 (Small) for 6.0 – 7.5 ID ET tubes 
Comparator Agent  Macintosh laryngoscope  Group M: Macintosh laryngoscope blade size 3 for females and size 4 for males for laryngoscopy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients in 18 to 60 year age group, weighing 40 to 70kg, belonging to ASA PS 1 or 2, scheduled for elective surgery under general anaesthesia requiring tracheal intubation, systolic blood pressure <140mm Hg and diastolic blood pressure <90mmHg on preoperative assessment. 
 
ExclusionCriteria 
Details  1.Hypertension/Hypotension
2.Ischaemic heart disease
3.Anticipated difficult airway
4.Pregnancy or lactation
5.Signs and symptoms of raised intracranial pressure
6.Head injury
7.Cervical spine disease
8. BMI>30kg/m2
9. 2nd or 3rd degree heart block
10.Risk of gastric aspiration
11.Reactive airway disease
12.Patients on drugs affecting blood pressure/HR
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The outcome variables of heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) mean arterial pressure (MAP) will be recorded   Pre-induction Baseline value
1 minute before intubation
At intubation and 4. Every minute for five minutes after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of Intubation
Intubation Attempt
Ease of intubation
Glottic View 
At the time if Intubation 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="66" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2013 
Date of Study Completion (India) 22/12/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   No Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Laryngoscopy and tracheal intubation are associated with varied levels of sympathetic stimulation. The accompanying increase in heart rate and blood pressure can have deleterious effects. Patients with cardio vascular compromise, elderly, neurological insult requires measures to curb or avoid these changes. Various pharmacological agents have been used to blunt the fluctuations in hemodynamic parameters. The choice of airway equipment can also play a role in the severity of sympathetic stimulation to laryngoscopy and intubation. There is mechanical stretch and stimulation of structures of the airway during laryngoscopy. The magnitude of cardio vascular response is related to the force and duration of laryngoscopy. The alterations in hemodynamic parameters have deleterious effects on patient physiology and is best avoided or attenuated.Most often patients after trauma have associated head injury. This subgroup requires maintenance of hemodynamic and intracranial pressure. However not many studies have compared the difference with respect to hemodynamic changes among various airway equipments. [1]The AirtraQ® is a novel intubation device that has been developed to facilitate tracheal intubation in patients with normal or difficult airways. The blade of the AirtraQ® consists of two side by side channels. One channel acts as a conduit through which a tracheal tube (ETT) can be passed, whilst the other channel contains a series of lenses, prisms and mirrors that transfers the image from the illuminated tip to a proximal viewfinder, giving a high quality wide-angle view of the glottis and surrounding structures, and the tip of the tracheal tube.[2]

Patients with suspected cervical injury requiring intubation depend on such airway device as alignment between oral, pharyngeal and laryngeal axes are not required. Macintosh laryngoscope blade is still the most widely used airway device also being used in patients needing manual in line stabilization. Thus we wish to compare these two devices for use in patients with simulated cervical spine injury with respect to the hemodynamic fluctuations produced in each of them. 
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