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

Recruiting

• Conditions: patients with coronary artery disease who have to undergo coronary artery bypass grafting under general anaesthesia

• Registration Number: CTRI/2013/04/003554
• Lead Sponsor: G B pant Hospital

Brief Summary

**SUMMARY OF THE PROTOCOL**

Hemodynamic responsesto laryngoscopy and tracheal intubation are concerning, as adversecardiovascular events may develop in patients with and without cardiovasculardisease. Videolaryngoscopes minimize oropharyngolaryngeal stimulation duringlaryngoscopy and hence might attenuate this stress response.  Previous studies have shown that trachealintubation using Truview EVO2 and McGrath® blade provided improved laryngeal view as compared toMacintosh blade.

Weaim to do a prospective randomized controlled study to see if hemodynamicresponses can be attenuated with the use of videolaryngoscopes.  After approval from our institutional ethicscommittee and obtaining written preoperative informed consent, sixty adultpatients , undergoing elective CABG, will be randomly allocated using computergenerated random numbers to either MC (MacIntosh) group (n = 20), MG (McGrath®)group (n = 20) or TV(Truview PCDTM) group (n=20) for orotrachealtube placement using direct laryngoscopy by a number 3 or 4 Macintosh blade,McGrath® or a Truview PCDTM videolaryngoscope,  respectively. Cases where intubation will not besuccessful despite three attempts will be excluded from the trial.

5-leadECG for heart rate (HR)and ST segment analysis, invasive systemic arterialpressures (SBP,DBP,MAP), diastolic and mean pulmonary arterial pressures (PADP,MPAP), central venous pressure (CVP),cardiac output (CO), systemic  vascular resistance index (SVRI), pulmonaryvascular resistance index (PVRI), pulse oximetry, end tidal capnography,nasopharyngeal temperature monitoring and arterial blood gas analysis will beperformed in all patients. Hemodynamic changes, laryngoscopic grade, number ofattempts, the time required for laryngoscopy and tracheal intubation and intra/post-operativecomplications will be recorded. Glottic view will be evaluated using modified Cormack andLehane Scoring System (mC-L) and percentage of glottis opening (POGO) score.Three attempts at intubation will be allowed for all groups. Intubation difficultyscore will also be assessed. Failure to intubate will be defined as inabilityto intubate after three attempts. An alternative technique will be used incases of failure as per the discretion of the anesthesiologist. The duration ofeach attempt will also be recorded. Glyceryltrinitrate (NTG) at a dose of1μg/kg iv will be instituted whenever the SBP increases by ≥ 20% of baseline oris persistently ≥160  mm Hg for a minute,whichever is higher. Total requirement of NTG will also be assessed. Patientswill be evaluated at 24 hours after intubation for any throat pain or sorethroat.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-10
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Adult patients with coronary artery disease undergoing coronary artery bypass grafting under general anaesthesia.

Exclusion Criteria

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%.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dept. of Anaesthesia, GB Pant Hospital; 🇮🇳 Central, DELHI, India

Dept. of Anaesthesia, GB Pant Hospital

🇮🇳Central, DELHI, India

Dr Deepak Tempe

Principal investigator

9718599401

tempedeepak@hotmail.com