Hemodynamic Responses of Different Laryngoscopes

NCT ID: NCT02469363

Last Updated: 2015-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-10-31

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.

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.

Conditions

Heart Rate and Rhythm Disorders; Blood Pressures; Oxygen Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Macintosh laryngoscope

Endotracheal intubation with classic (Macintosh) laryngoscope

Group Type: ACTIVE_COMPARATOR

Macintosh laryngoscope

Intervention Type: DEVICE

Hemodynamic parameters after endotracheal intubation with Classic laryngoscope (Macintosh)

Mc-Coy laryngoscope

Endotracheal intubation with Mc-Coy laryngoscope

Group Type: ACTIVE_COMPARATOR

Mc-Coy laryngoscope

Intervention Type: DEVICE

Hemodynamic parameters after endotracheal intubation with Mc-Coy laryngoscope

C-Mac videolaryngoscope

Endotracheal intubation with C-Mac videolaryngoscope

Group Type: ACTIVE_COMPARATOR

C-Mac videolaryngoscope

Intervention Type: DEVICE

Hemodynamic parameters after endotracheal intubation with C-Mac videolaryngoscope

McGrath videolaryngoscope

Endotracheal intubation with McGrath videolaryngoscope

Group Type: ACTIVE_COMPARATOR

McGrath videolaryngoscope

Intervention Type: DEVICE

Hemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope

Interventions

Macintosh laryngoscope

Hemodynamic parameters after endotracheal intubation with Classic laryngoscope (Macintosh)

Intervention Type: DEVICE

Mc-Coy laryngoscope

Hemodynamic parameters after endotracheal intubation with Mc-Coy laryngoscope

Intervention Type: DEVICE

C-Mac videolaryngoscope

Hemodynamic parameters after endotracheal intubation with C-Mac videolaryngoscope

Intervention Type: DEVICE

McGrath videolaryngoscope

Hemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Demet Altun

Attending Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Demet Altun, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University, Department of Anesthesiology an Reanimation

Locations

Istanbul University, Department of Anesthesiology

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2014/1191

Identifier Type: -

Identifier Source: org_study_id