Evaluation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation Using Conventional Laryngoscope Versus C-MAC Video Laryngoscope in Patients Undergoing Elective Coronary Artery Bypass Grafting (CABG) Surgery

Evaluation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation Using Conventional Laryngoscope Versus C-MAC Video Laryngoscope in Patients Undergoing Elective Coronary Artery Bypass Grafting (CABG) Surgery - A Randomized Control Trial.

This study is being done to compare hemodynamic response upon endotracheal intubation using either conventional laryngoscopy with Macintosh blade versus C-Mac video laryngoscope in patients undergoing elective coronary artery bypass grafting without anticipated difficult airway.

Study Overview

• Status: Unknown
• Conditions: Intubation Complication
• Intervention / Treatment: Device: Endotracheal intubation using a laryngoscope

Detailed Description

Patients will be premeditated with 7.5mg oral midazolam approximately 45-60 minutes prior to anesthesia. The standard monitoring of Electrocardiography for ST analysis and SPO2 will be monitored continuously. Capnography, tidal volume and airway pressure will also be monitored during anesthesia. Arterial line for invasive Blood Pressure monitoring, wide bore IV cannula will be placed before induction of anesthesia. Anesthesia technique will be standardized in both groups. After pre-oxygenation, anesthesia co-induction will be done with midazolam 0.02-0.05 mg/kg, propofol 0.5-1mg/kg and fentanyl 5mcg/kg. Cis-atracurium 0.15mg/kg will be used as muscle relaxant. Patient will be ventilated manually by using isoflurane (1% end tidal) in oxygen using facemask. ETT will be placed orally via direct laryngoscopy by MC and C-MAC blade 3 or 4 when a Train of Four would not be achieved. All intubation will be performed by senior experienced anesthetist having experience of at least 20 intubations using video laryngoscope.

After induction a central venous catheter will be placed for central venous pressure monitoring and a thermo dilution Swan Ganz catheter will be inserted if indicated.

Tracheal intubation will be performed using the standard Macintosh laryngoscope(MC) or C- MAC video laryngoscope (VL) (Karl Storz, Tuttlingen, Germany).

Hemodynamic changes, laryngoscopic view, the number of attempts, the time required for laryngoscopy and tracheal intubation, changes in rhythm, and intraoperative and post operative complications will be recorded. Heart rate (HR), systolic arterial pressure (SAP), diastolic arterial pressure (DAP) and mean arterial pressure (MAP) along with peripheral oxygen saturation (SpO2), will be recorded before (T1) and after induction (T2), 1 minute after intubation (T3), 5 min (T4) and 10 min (T5)post intubation. End tidal carbon dioxide (EtCO2) will be recorded immediately after induction (T2), immediately after intubation 1 minute (T3), 5 min (T4) and 10 min (T5) post intubation. Measurements obtained after induction of anesthesia when the hemodynamics will be stable (post induction) will be considered as baseline measurements in the study.

Duration of laryngoscopy (DOL) is defined as the time from oral placement of the laryngoscope blade to obtaining the best glottic view. For the evaluation of glottic view during laryngoscopy, modified Cormack and Lehane Scoring System (m CL) and percentage of the glottis opening (POGO) score will be used. Duration of intubation (DOI) is defined as the time interval between oral placement of the ET to the attainment of tracing of 3 EtCO2 waveforms after intubation and initiation of mechanical ventilation. An attempt is defined as the time from introduction of laryngoscope into the oral cavity until its removal. Three attempts at intubation will be allowed for all groups. Failure to intubate will be defined as the inability to intubate after three attempts. An alternative technique will be used in cases of failure as per the discretion of anesthetist. In the case of multiple attempts, the duration of each attempt will be recorded. The duration of laryngoscopy and intubation (DOLI) is defined as the sum of all intubation attempts. The hemodynamic changes after intubation will be evaluated after successful intubation. After the study period, the anesthetic agents will be used as per the patient requirement. A number of unsuccessful attempts of intubation, complications encountered during intubation (bleeding, lacerations, dental injury, etc.,), and optimal laryngeal external manipulation (OLEM) during intubation will be recorded. The management of these complications will be done by primary anaesthesia team as per their feasibility and the costs of management of these complications will be covered under hospital insurance. Difficult intubation will be assessed by using Intubation Difficulty score (Table 1), Thyromental distance and Upper lip bite test.

Adverse effects of A number unsuccessful attempts of intubation, complications encountered during intubation (bleeding, lacerations, dental injury, etc.,), and optimal laryngeal external manipulation (OLEM) during intubation will be recorded.

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sehrish Khan, MBBS; Phone Number: 923347126366; Email: sehrish.khan@aku.edu
• Study Contact Backup: Name: Khalid Samad, MBBS,FCPS(Anesthesiology); Phone Number: 923343311603; Email: khalid.samad@aku.edu

Study Locations

• Pakistan
  • Sind
    • Karachi, Sind, Pakistan
      • Recruiting
      • Department of Anesthesiology
      • Contact: Khalid Samad, MBBS,FCPS(Anesthesiology); Phone Number: 923343311603; Email: khalid.samad@aku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 35-65
• Elective Coronary Artery By Pass Grafting
• American Society Of Anesthesiologist III/IV
• Unanticipated difficult airway
• Mallampati I-II

Exclusion Criteria:

• Obese Body Mass Index > 35kg/m2
• Left Main Coronary Artery critical Disease
• Recent MI or unstable Angina
• Left heart failure/ Left ventricular ejection fraction<35%
• Upper lip bite test class III
• Thyromental distance <6.0 cm
• Emergency surgery
• Anticipated difficult airway
• Respiratory Diseases
• Bleeding diathesis
• Neurological deficit
• Limited nuchal Range of motion
• Gastro Esophageal Reflux Disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Conventional MAC Laryngoscope; Patients in this group will undergo intubation using conventional macintosh laryngoscope	Device: Endotracheal intubation using a laryngoscope; Patients will undergo intubation using 2 different types of laryngoscopes and their hemodynamic response would be recorded
EXPERIMENTAL: C-MAC Video laryngoscope; Patients in this group will undergo intubation using video C-Mac laryngoscope	Device: Endotracheal intubation using a laryngoscope; Patients will undergo intubation using 2 different types of laryngoscopes and their hemodynamic response would be recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood pressure (in millimeters of Hg)	Hemodynamic response	Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation
Changes in heart rate (beats per minute)	Hemodynamic response	Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arrhythmias	Presence of arrhythmias would be noted	Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation
Perioperative myocardial ischemia	Presence of myocardial ischemia would be noted by ST segment changes	Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation

Collaborators and Investigators

• Sponsor: Aga Khan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 7, 2020
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): January 31, 2021

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (ACTUAL): June 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 15, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2020-3278-9046

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No