Hemodynamic Responses of Different Laryngoscopes

Comparison of Different Laryngoscopes in Terms of Hemodynamic Responses

During laryngoscopy and endotracheal intubation, stimulation of supraglottic regions leads to an increase in the plasma catecholamine concentrations due to the activation of the sympatho-adrenal system. Prevention or reduction of this increment is important for hemodynamic control. Therefore, various methods such as providing adequate depth of anesthesia and shortening the time of laryngoscopy were used. On the other hand; alternative laryngoscopy devices and techniques have recently started to be used.

In this randomized single blind study, the aim is to compare the hemodynamic responses of four different laryngoscopy techniques with Macintosh laryngoscope, McCoy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope in patients with normal predictive airway.

Study Overview

• Status: Completed
• Conditions: Heart Rate and Rhythm Disorders; Blood Pressures; Oxygen Disorders
• Intervention / Treatment: Device: Macintosh laryngoscope; Device: Mc-Coy laryngoscope; Device: C-Mac videolaryngoscope; Device: McGrath videolaryngoscope

Detailed Description

During laryngoscopy and endotracheal intubation, stimulation of supraglottic regions leads to an increase in the plasma catecholamine concentrations due to the activation of the sympatho-adrenal system. Prevention or reduction of this increment is important for hemodynamic control. Therefore, various methods such as providing adequate depth of anesthesia and shortening the time of laryngoscopy were used. On the other hand; alternative laryngoscopy devices and methods have recently started to be used.

In this randomized single blind study, our aim is to compare the hemodynamic responses of four different laryngoscopy techniques with Macintosh laryngoscope, McCoy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope in patients with normal predictive airway.

After obtaining Institutional Ethics Committee approval and patient consents, 170 patients (18-65 years old) with ASA I-II status requiring general anesthesia with endotracheal intubation, were enrolled to this prospective randomized study.

Besides routine monitorization (noninvasive blood pressure (NIBP), electrocardiography (ECG), heart rate (HR), peripheral oxygen saturation (SPO2)), continuous BIS monitorization was also performed. Sedation was performed using a standard dose of IV fentanyl (1.5 μg/kg) and midazolam (0.05 mg/kg). Baseline systolic, diastolic and mean arterial blood pressures, HR and SPO2 values were recorded as T0. After a stabilization period of 10 minutes, propofol 2-3 mg/kg IV bolus was applied incrementally until a clinically desirable sedation level was achieved. If necessary, additional propofol boluses were given to maintain a BIS level of 60. As soon as BIS level was reduced to 60, patients were put on 0.6 mg/kg IV rocuronium. 100% oxygen was applied with a facemask for a period of 3 minutes. Then, post induction values (T1) were recorded.

One hundred seventy patients were randomly allocated equally to Macintosh laryngoscope, Mc-Coy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope groups. Endotracheal tube (ETT) of 7.0 mm and 7.5 mm were placed to female and male patients, respectively. All intubation procedures were performed by a single experienced anesthesiologist. Intubation stylet was provided, if necessary. Cuff pressures of endotracheal tubes were standartized to 30 cmH2O via a manometer. The following measurements were recorded immediately after intubation (T2) and at one minute intervals for 5 minutes (T3, T4, T5, T6 and T7).

Moreover; the number of intubation attempts, stylet needs, Cormack-Lehane scales, and the complications occurred during intubation procedures were recorded as the second outcomes. Patients were also questioned for possible sore throat at postoperative 2 hours. Patients requiring more than one attempt to achieve successful intubation were excluded from statistical analysis of data.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Istanbul University, Department of anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with ASA I-II status, requiring general anesthesia with endotracheal intubation

Exclusion Criteria:

• ASA status higher than II, a history or suspected of difficult airway, hypertansion, under treatment known to affect blood pressure or heart rate (Beta blocker/ Ca-channel blocker), BIS value > 60

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Macintosh laryngoscope; Endotracheal intubation with classic (Macintosh) laryngoscope	Device: Macintosh laryngoscope; Hemodynamic parameters after endotracheal intubation with Classic laryngoscope (Macintosh)
Active Comparator: Mc-Coy laryngoscope; Endotracheal intubation with Mc-Coy laryngoscope	Device: Mc-Coy laryngoscope; Hemodynamic parameters after endotracheal intubation with Mc-Coy laryngoscope
Active Comparator: C-Mac videolaryngoscope; Endotracheal intubation with C-Mac videolaryngoscope	Device: C-Mac videolaryngoscope; Hemodynamic parameters after endotracheal intubation with C-Mac videolaryngoscope
Active Comparator: McGrath videolaryngoscope; Endotracheal intubation with McGrath videolaryngoscope	Device: McGrath videolaryngoscope; Hemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial blood pressure	Hemodynamic parameters as systolic, diastolic and mean arterial blood pressures were recorded during and after induction	Change from baseline in blood pressures at first 20 minutes
Heart rate	Hemodynamic parameters as heart rates were recorded during and after induction	Change from baseline in heart rates at first 20 minutes
SPO2 value	Hemodynamic parameters as SPO2 values were recorded during and after induction	Change from baseline in SPO2 values at first 20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intubation attempts	Number of intubation attempts were recorded	During endotracheal intubation
Stylet need	Stylet need was recorded	During endotracheal intubation
Cormach-Lehane scales	Cormack-Lehane scales were recorded	During endotracheal intubation
Complications	Possible complications were recorded	During endotracheal intubation
Sore throat	Possible sore throat was recorded	Postoperative 2 hours

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Demet Altun, MD, Istanbul University, Department of Anesthesiology an Reanimation

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: June 5, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 11, 2015

Study Record Updates

• Last Update Posted (Estimate): June 12, 2015
• Last Update Submitted That Met QC Criteria: June 11, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Macintosh laryngoscope; McCoy laryngoscope; C-Mac videolaryngoscope; McGrath videolaryngoscope; Hemodynamic parameters
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 2014/1191