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Does Glidescope Video Laryngoscope is Related to Less Hemodynamic Response?

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ClinicalTrials.gov Identifier: NCT02708420
Recruitment Status : Completed
First Posted : March 15, 2016
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Gata Haydarpasa Research Hospital

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.

Condition or disease Intervention/treatment Phase
Blood Pressure Device: Glidescope Device: Macintosh Laryngoscope Not Applicable

Detailed Description:
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. After induction with our institutional protocol for cardiac bypass surgery, hemodynamic data including heart rate, systolic and diastolic arterial pressure data will be recorded. Time for intubation, age, sex, ASA status data will also be recorded.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Hemodynamic Responses to Endotracheal Intubation With Glidescope Video Laryngoscope and Macintosh Direct Laryngoscope in Patients Undergoing Coronary Artery Bypass Surgery
Study Start Date : January 1, 2016
Actual Primary Completion Date : May 18, 2017
Actual Study Completion Date : June 1, 2017

Arm Intervention/treatment
Glidescope intubation
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
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.

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




Primary Outcome Measures :
  1. Change in systolic blood pressure [ Time Frame: 5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes ]
    invasive blood pressure (mmHg) monitoring

  2. Change in heart rate [ Time Frame: 5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes ]
    Heart rate (beats per minute) will be measured before induction, and throughout and after laryngoscopy

  3. Change in diastolic blood pressure [ Time Frame: 5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes ]
    invasive blood pressure (mmHg) monitoring

  4. Change in mean arterial pressure [ Time Frame: 5 minutes;At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes ]
    invasive blood pressure (mmHg) monitoring


Secondary Outcome Measures :
  1. Procedure time [ Time Frame: 10 minutes ]
    Total laryngoscopy and intubation time (minutes)

  2. Cormack lehane laryngoscopic view will be recorded [ Time Frame: 10 minutes ]
    laryngoscopic view data will be recorded according to Cormack Lehane scale (A Scale with 1-4)



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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): NCT02708420


Locations
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Turkey
GATA Haydarpasa Training Hospital
İ̇stanbul, Asia, Turkey, 34668
Sponsors and Collaborators
Gata Haydarpasa Research Hospital
Investigators
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Study Chair: Sezai Ozkan, Prof. Gata Haydarpasa Research Hospital
Publications:

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Responsible Party: Gata Haydarpasa Research Hospital
ClinicalTrials.gov Identifier: NCT02708420    
Other Study ID Numbers: GataHRH
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Gata Haydarpasa Research Hospital:
Glidescope
Cardiovascular surgery
Macintosh Laryngoscope
Hemodynamic response
Anesthesia