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CTRI Number  CTRI/2013/04/003554 [Registered on: 15/04/2013] Trial Registered Retrospectively
Last Modified On: 13/03/2013
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   A clinical trial to study the effect of three laryngoscopes-Truview PCD, Mc Grath and Macintosh- on heart rate, blood pressure and other hemodynamic parameters in patients undergoing heart bypass surgery  
Scientific Title of Study   Comparison of hemodynamic responses to laryngoscopy and intubation with Truview PCD, McGrath® and Macintosh laryngoscope in patients undergoing CABG  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
F.I/IEC/MAMC/(32)4/2012/No.250  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepak Tempe  
Designation  Director Professor & Head 
Affiliation  Maulana Azad Medical College & associated G B Pant Hospital Delhi University  
Address  Department of Anaesthesia G B Pant Hospital

Central
DELHI
110002
India 
Phone  9718599401  
Fax    
Email  tempedeepak@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Deepak Tempe  
Designation  Director Professor & Head 
Affiliation  Maulana Azad Medical College & associated G B Pant Hospital Delhi University 
Address  Department of Anaesthesia G B Pant Hospital

Central
DELHI
110002
India 
Phone  9718599401  
Fax    
Email  tempedeepak@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Anitha  
Designation  Fellowship Student in Cardiac Anaesthesia 
Affiliation  Maulana Azad Medical College & associated G B Pant Hospital  
Address  Department of Anaesthesia G B Pant Hospital

Central
DELHI
110002
India 
Phone    
Fax    
Email  anu_8281@yahoo.co.in  
 
Source of Monetary or Material Support  
G B Pant Hospital , New Delhi  
 
Primary Sponsor  
Name  G B pant Hospital  
Address  G B Pant Hospital , New Delhi -2 
Type of Sponsor  Government medical college 
 
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 Deepak Tempe  Dept. of Anaesthesia, GB Pant Hospital  Dept. of Anaesthesia, GB Pant Hospital, New Delhi
Central
DELHI 
9718599401

tempedeepak@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, MAMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients with coronary artery disease who have to undergo coronary artery bypass grafting under general anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Macintosh laryngoscope  It is commonly used laryngoscope with a curved blade. 
Intervention  McGrath videolaryngoscope  The McGrath®videolaryngoscope (Aircraft Medical, Edinburgh, UK)(Fig 2) is a portable device which is powered by a single standard AA battery and features an on-board camera system and integral colour liquid crystal display mounted on the top of laryngoscope handle. A sterile, transparent, acrylic single-use blade is used to reduce the risk of patient-to-patient contamination. The handle and the screen can be cleaned using the alcohol-impregnated wipes. 
Intervention  Truview PCD laryngoscope   The TruViewPCD laryngoscope (Truphatek International Ltd, Netanya, Israel) is a recently introduced device with a unique blade that provides an optical view ‘around the corner’. The blade is a modified laryngoscope blade incorporating an unmagnified optic side port with an anterior fraction of 35% in the line of sight allowing indirect tracheal intubation.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adult patients with coronary artery disease undergoing coronary artery bypass grafting under general anaesthesia 
 
ExclusionCriteria 
Details  1) Patients with renal disease, hepatic disease , neurological disease and bleeding diathesis
2) Mallampati score of III-IV or history for a difficult intubation and limited nuchal range of motion
3) American Society of Anesthesiologists physical Status IV (ASA class IV)
4) Patients with gastroesophageal reflux disease, delayed gastric emptying
5) Serious respiratory disease, kyphoscoliosis
6) LVEF<35%
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
heart rate , systolic blood pressure   before and after induction, immediately after intubation, and at 1, 2, 3, 4, 5 and 10 minutes- post intubation 
 
Secondary Outcome  
Outcome  TimePoints 
diastolic arterial pressure (DAP), mean arterial pressure (MAP), mean pulmonary arterial pressure (MPAP), pulmonary artery diastolic pressure( PADP), peripheral oxygen saturation (SpO2)   before and after induction, immediately after intubation, and at 1, 2, 3, 4, 5 and 10 minutes- post intubation 
Cardiac output( CO), systemic vascular resistance index( SVRI), and pulmonary vascular resistance index( PVRI)   before and after induction, and at 1, 5 and 10 minutes- post intubation 
Duration of laryngoscopy   the time from oral placement of laryngoscope blade to obtaining the best glottis view 
modified Cormack and Lehane Scoring System (mC-L) and percentage of glottis view (POGO) score   during laryngoscopy 
Number of unsuccessful attempts of intubation (if any), complications encountered during intubation(bleeding, lacerations, dental injury, etc.), the neck extension need with videolaryngoscopes and optimum laryngeal external manipulation( OLEM) need, Intubation difficulty score  during intubation  
need for nitroglycerine  immediately after intubation, and at 1, 2, 3, 4, 5 and 10 minutes- post intubation 
Duration of intubation   time interval between oralplacement of endotracheal tube to the attainment of tracing of 3 end tidal CO2 waveforms 
throat pain or sore throat  24 hours after intubation 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   04/10/2012 
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)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

SUMMARY OF THE PROTOCOL 

Hemodynamic responses to laryngoscopy and tracheal intubation are concerning, as adverse cardiovascular events may develop in patients with and without cardiovascular disease. Videolaryngoscopes minimize oropharyngolaryngeal stimulation during laryngoscopy and hence might attenuate this stress response.  Previous studies have shown that tracheal intubation using Truview EVO2 and McGrath® blade provided improved laryngeal view as compared to Macintosh blade.

We aim to do a prospective randomized controlled study to see if hemodynamic responses can be attenuated with the use of videolaryngoscopes.  After approval from our institutional ethics committee and obtaining written preoperative informed consent, sixty adult patients , undergoing elective CABG, will be randomly allocated using computer generated random numbers to either MC (MacIntosh) group (n = 20), MG (McGrath®) group (n = 20) or TV(Truview PCDTM) group (n=20) for orotracheal tube placement using direct laryngoscopy by a number 3 or 4 Macintosh blade, McGrath® or a Truview PCDTM videolaryngoscope,  respectively.  Cases where intubation will not be successful despite three attempts will be excluded from the trial.

5-lead ECG for heart rate (HR)and ST segment analysis, invasive systemic arterial pressures (SBP,DBP,MAP), diastolic and mean pulmonary arterial pressures (PADP, MPAP), central venous pressure (CVP),cardiac output (CO), systemic  vascular resistance index (SVRI), pulmonary vascular resistance index (PVRI), pulse oximetry, end tidal capnography, nasopharyngeal temperature monitoring and arterial blood gas analysis will be performed in all patients. Hemodynamic changes, laryngoscopic grade, number of attempts, the time required for laryngoscopy and tracheal intubation and intra/post-operative complications will be recorded. Glottic view will be evaluated using modified Cormack and Lehane Scoring System (mC-L) and percentage of glottis opening (POGO) score. Three attempts at intubation will be allowed for all groups. Intubation difficulty score will also be assessed. Failure to intubate will be defined as inability to intubate after three attempts. An alternative technique will be used in cases of failure as per the discretion of the anesthesiologist. The duration of each attempt will also be recorded. Glyceryltrinitrate (NTG) at a dose of 1μg/kg iv will be instituted whenever the SBP increases by ≥ 20% of baseline or is persistently ≥160  mm Hg for a minute, whichever is higher. Total requirement of NTG will also be assessed. Patients will be evaluated at 24 hours after intubation for any throat pain or sore throat.

 
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