NCT02708420

Brief Summary

Laryngoscopy and endotracheal intubation causes significant hemodynamic response and thus presents an increased risk for patients undergoing cardiac bypass surgery. Prevention or reduction of this increment is important for hemodynamic control. In this randomized single blind study, the aim of this study is to compare the hemodynamic responses of two different laryngoscopy techniques with Glidescope and Macintosh laryngoscope in coronary cardiac bypass surgery patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2017

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 14, 2017

Status Verified

March 1, 2016

Enrollment Period

1.4 years

First QC Date

February 27, 2016

Last Update Submit

June 12, 2017

Conditions

Keywords

GlidescopeCardiovascular surgeryMacintosh LaryngoscopeHemodynamic responseAnesthesia

Outcome Measures

Primary Outcomes (4)

  • Change in systolic blood pressure

    invasive blood pressure (mmHg) monitoring

    5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes

  • Change in heart rate

    Heart rate (beats per minute) will be measured before induction, and throughout and after laryngoscopy

    5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes

  • Change in diastolic blood pressure

    invasive blood pressure (mmHg) monitoring

    5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes

  • Change in mean arterial pressure

    invasive blood pressure (mmHg) monitoring

    5 minutes;At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes

Secondary Outcomes (2)

  • Procedure time

    10 minutes

  • Cormack lehane laryngoscopic view will be recorded

    10 minutes

Study Arms (2)

Glidescope intubation

OTHER

This standard GlideScope (GS) technique involves a midline laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.

Device: Glidescope

Macintosh Laryngoscope

OTHER

This standard technique involves laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.

Device: Macintosh Laryngoscope

Interventions

This standard GlideScope (GS) technique involves a midline laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.

Glidescope intubation

This technique involves a laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.

Macintosh Laryngoscope

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical Status 2-3
  • Patients undergoing elective cardiac bypass surgery

You may not qualify if:

  • Difficult intubation history
  • Need for Rapid sequence intubation or alternative intubation method
  • Emergency procedures
  • Patients that have predictive factors for difficult intubation
  • Patients with permanent pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GATA Haydarpasa Training Hospital

Istanbul, Asia, 34668, Turkey (Türkiye)

Location

Related Publications (9)

  • Friedman Z, Gurevich L, Siddiqui N. The effect of a modified GlideScope intubation technique on procedure times, airway morbidity and haemodynamic response. Eur J Anaesthesiol. 2016 Mar;33(3):229-30. doi: 10.1097/EJA.0000000000000339. No abstract available.

    PMID: 26760401BACKGROUND
  • Amini S, Shakib M. Hemodynamic changes following endotracheal intubation in patients undergoing cesarean section with general anesthesia: application of glidescope(R) videolaryngoscope versus direct laryngoscope. Anesth Pain Med. 2015 Mar 30;5(2):e21836. doi: 10.5812/aapm.21836. eCollection 2015 Apr.

    PMID: 25866708BACKGROUND
  • Dashti M, Amini S, Azarfarin R, Totonchi Z, Hatami M. Hemodynamic changes following endotracheal intubation with glidescope((R)) video-laryngoscope in patients with untreated hypertension. Res Cardiovasc Med. 2014 May;3(2):e17598. doi: 10.5812/cardiovascmed.17598. Epub 2014 Apr 1.

    PMID: 25478537BACKGROUND
  • Aqil M. A study of stress response to endotracheal intubation comparing glidescope and flexible fiberoptic bronchoscope. Pak J Med Sci. 2014 Sep;30(5):1001-6. doi: 10.12669/pjms.305.4788.

    PMID: 25225515BACKGROUND
  • Pournajafian AR, Ghodraty MR, Faiz SH, Rahimzadeh P, Goodarzynejad H, Dogmehchi E. Comparing GlideScope Video Laryngoscope and Macintosh Laryngoscope Regarding Hemodynamic Responses During Orotracheal Intubation: A Randomized Controlled Trial. Iran Red Crescent Med J. 2014 Apr;16(4):e12334. doi: 10.5812/ircmj.12334. Epub 2014 Apr 5.

    PMID: 24910788BACKGROUND
  • Maassen RL, Pieters BM, Maathuis B, Serroyen J, Marcus MA, Wouters P, van Zundert AA. Endotracheal intubation using videolaryngoscopy causes less cardiovascular response compared to classic direct laryngoscopy, in cardiac patients according a standard hospital protocol. Acta Anaesthesiol Belg. 2012;63(4):181-6.

    PMID: 23610856BACKGROUND
  • Siddiqui N, Katznelson R, Friedman Z. Heart rate/blood pressure response and airway morbidity following tracheal intubation with direct laryngoscopy, GlideScope and Trachlight: a randomized control trial. Eur J Anaesthesiol. 2009 Sep;26(9):740-5. doi: 10.1097/EJA.0b013e32832b138d.

    PMID: 19417675BACKGROUND
  • Xue FS, Zhang GH, Li XY, Sun HT, Li P, Li CW, Liu KP. Comparison of hemodynamic responses to orotracheal intubation with the GlideScope videolaryngoscope and the Macintosh direct laryngoscope. J Clin Anesth. 2007 Jun;19(4):245-50. doi: 10.1016/j.jclinane.2006.11.004.

    PMID: 17572317BACKGROUND
  • Russell T, Khan S, Elman J, Katznelson R, Cooper RM. Measurement of forces applied during Macintosh direct laryngoscopy compared with GlideScope(R) videolaryngoscopy. Anaesthesia. 2012 Jun;67(6):626-31. doi: 10.1111/j.1365-2044.2012.07087.x. Epub 2012 Feb 21.

    PMID: 22352799BACKGROUND

Study Officials

  • Sezai Ozkan, Prof.

    Gata Haydarpasa Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2016

First Posted

March 15, 2016

Study Start

January 1, 2016

Primary Completion

May 18, 2017

Study Completion

June 1, 2017

Last Updated

June 14, 2017

Record last verified: 2016-03

Locations