NCT02469363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

2 months

First QC Date

June 5, 2015

Last Update Submit

June 11, 2015

Conditions

Heart Rate and Rhythm DisordersBlood PressuresOxygen Disorders

Keywords

Macintosh laryngoscopeMcCoy laryngoscopeC-Mac videolaryngoscopeMcGrath videolaryngoscopeHemodynamic parameters

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Number of intubation attempts

    During endotracheal intubation

  • Stylet need

    During endotracheal intubation

  • Cormach-Lehane scales

    During endotracheal intubation

  • Complications

    During endotracheal intubation

  • Sore throat

    Postoperative 2 hours

Study Arms (4)

Macintosh laryngoscope

ACTIVE COMPARATOR

Endotracheal intubation with classic (Macintosh) laryngoscope

Device: Macintosh laryngoscope

Mc-Coy laryngoscope

ACTIVE COMPARATOR

Endotracheal intubation with Mc-Coy laryngoscope

Device: Mc-Coy laryngoscope

C-Mac videolaryngoscope

ACTIVE COMPARATOR

Endotracheal intubation with C-Mac videolaryngoscope

Device: C-Mac videolaryngoscope

McGrath videolaryngoscope

ACTIVE COMPARATOR

Endotracheal intubation with McGrath videolaryngoscope

Device: McGrath videolaryngoscope

Interventions

Macintosh laryngoscopeDEVICE

Hemodynamic parameters after endotracheal intubation with Classic laryngoscope (Macintosh)

Macintosh laryngoscope
Mc-Coy laryngoscopeDEVICE

Hemodynamic parameters after endotracheal intubation with Mc-Coy laryngoscope

Mc-Coy laryngoscope
C-Mac videolaryngoscopeDEVICE

Hemodynamic parameters after endotracheal intubation with C-Mac videolaryngoscope

C-Mac videolaryngoscope
McGrath videolaryngoscopeDEVICE

Hemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope

McGrath videolaryngoscope

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, 34093, Turkey (Türkiye)

Location

Study Officials

  • Demet Altun, MD

    Istanbul University, Department of Anesthesiology an Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Anesthesiologist

Study Record Dates

First Submitted

June 5, 2015

First Posted

June 11, 2015

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

TU(1)