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
|
|
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
|
|
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. |