Hemodynamic Responses of Different Laryngoscopes

Sponsor

Istanbul University (Other)

Overall Status

Completed

CT.gov ID

NCT02469363

Collaborator

(none)

170

Enrollment

Location

Arms

Duration (Months)

84.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Rate and Rhythm Disorders Blood Pressures Oxygen Disorders	Device: Macintosh laryngoscope Device: Mc-Coy laryngoscope Device: C-Mac videolaryngoscope Device: McGrath videolaryngoscope	Phase 4

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Screening

Official Title:

Comparison of Different Laryngoscopes in Terms of Hemodynamic Responses

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Number of intubation attempts [During endotracheal intubation]
Number of intubation attempts were recorded
Stylet need [During endotracheal intubation]
Stylet need was recorded
Cormach-Lehane scales [During endotracheal intubation]
Cormack-Lehane scales were recorded
Complications [During endotracheal intubation]
Possible complications were recorded
Sore throat [Postoperative 2 hours]
Possible sore throat was recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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