Hemodynamic Responses of Different Laryngoscopes

Heart Rate and Rhythm Disorders Clinical Trial

Official title:

Comparison of Different Laryngoscopes in Terms of Hemodynamic Responses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469363
• Other study ID #: 2014/1191
• Status: Completed
• Phase: Phase 4
• First received: June 5, 2015
• Last updated: June 11, 2015
• Start date: August 2014
• Est. completion date: October 2014

Study information

• Verified date: June 2015
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Blood Pressures
• Disease
• Heart Rate and Rhythm Disorders
• Oxygen Disorders

Intervention

Device:
• Macintosh laryngoscope
Hemodynamic parameters after endotracheal intubation with Classic laryngoscope (Macintosh)
• Mc-Coy laryngoscope
Hemodynamic parameters after endotracheal intubation with Mc-Coy laryngoscope
• C-Mac videolaryngoscope
Hemodynamic parameters after endotracheal intubation with C-Mac videolaryngoscope
• McGrath videolaryngoscope
Hemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope

Locations

Country	Name	City	State
Turkey	Istanbul University, Department of Anesthesiology	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Heart rate	Hemodynamic parameters as heart rates were recorded during and after induction	Change from baseline in heart rates at first 20 minutes	Yes
Primary	SPO2 value	Hemodynamic parameters as SPO2 values were recorded during and after induction	Change from baseline in SPO2 values at first 20 minutes	Yes
Secondary	Number of intubation attempts	Number of intubation attempts were recorded	During endotracheal intubation	Yes
Secondary	Stylet need	Stylet need was recorded	During endotracheal intubation	Yes
Secondary	Cormach-Lehane scales	Cormack-Lehane scales were recorded	During endotracheal intubation	Yes
Secondary	Complications	Possible complications were recorded	During endotracheal intubation	Yes
Secondary	Sore throat	Possible sore throat was recorded	Postoperative 2 hours	Yes