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Hemodynamic Responses of Different Laryngoscopes

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ClinicalTrials.gov Identifier: NCT02469363
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
Demet Altun, Istanbul University

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:

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.

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Study Type : Interventional  (Clinical Trial)
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 : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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




Primary Outcome Measures :
  1. Arterial blood pressure [ Time Frame: 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

  2. Heart rate [ Time Frame: Change from baseline in heart rates at first 20 minutes ]
    Hemodynamic parameters as heart rates were recorded during and after induction

  3. SPO2 value [ Time Frame: Change from baseline in SPO2 values at first 20 minutes ]
    Hemodynamic parameters as SPO2 values were recorded during and after induction


Secondary Outcome Measures :
  1. Number of intubation attempts [ Time Frame: During endotracheal intubation ]
    Number of intubation attempts were recorded

  2. Stylet need [ Time Frame: During endotracheal intubation ]
    Stylet need was recorded

  3. Cormach-Lehane scales [ Time Frame: During endotracheal intubation ]
    Cormack-Lehane scales were recorded

  4. Complications [ Time Frame: During endotracheal intubation ]
    Possible complications were recorded

  5. Sore throat [ Time Frame: Postoperative 2 hours ]
    Possible sore throat was recorded



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469363


Locations
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Turkey
Istanbul University, Department of Anesthesiology
Istanbul, Turkey, 34093
Sponsors and Collaborators
Istanbul University
Investigators
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Principal Investigator: Demet Altun, MD Istanbul University, Department of Anesthesiology an Reanimation
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Responsible Party: Demet Altun, Attending Anesthesiologist, Istanbul University
ClinicalTrials.gov Identifier: NCT02469363    
Other Study ID Numbers: 2014/1191
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015
Keywords provided by Demet Altun, Istanbul University:
Macintosh laryngoscope
McCoy laryngoscope
C-Mac videolaryngoscope
McGrath videolaryngoscope
Hemodynamic parameters
Additional relevant MeSH terms:
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Disease
Pathologic Processes