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Comparison of Two Different Videolaryngoscopes Regarding Hemodynamic Parameters in Open Heart Surgey

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ClinicalTrials.gov Identifier: NCT03483285
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Tülay Çardaközü, Kocaeli University

Brief Summary:
Endotracheal intubation increased the heart rate and blood pressure in normal patients. Open heart surgery patients are more prone to hemodynamic variability. In addition, they have increased possibility for difficult intubation The heart rate and blood pressure increase impaired the oxygen consumption. This was previously shown that Videolaryngoscopes minimaly effects the vital signs in normal patients. Videolaryngoscopy inreased the rate of success in normal and difficult airway. This study aimed to compare two laryngoscopes regarding hemodynamic parameters and intubation times in coronary bypass surgery.

Condition or disease Intervention/treatment Phase
Intubation;Difficult Coronary Bypass Device: airtraq Device: storz Not Applicable

Detailed Description:

Aim: Endotracheal intubation increased the heart rate and blood pressure in normal patients. Open heart surgery patients are more prone to hemodynamic variability. In addition, they have increased possibility for difficult intubation The heart rate and blood pressure increase impaired the oxygen consumption. This was previously shown that Videolaryngoscopes minimaly effects the vital signs in normal patients. Videolaryngoscopy inreased the rate of success in normal and difficult airway. This study aimed to compare two laryngoscopes regarding hemodynamic parameters and intubation times in coronary bypass surgery.

Material and methods: 50 patients undergoing coronary bypass surgery enrolled in this prospective.randomized study. Demogaphic variables and airway characteristics of patients were recorded. Glottic visulisation and intubation time were recorded. Systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate were recorded 2 minutes intervals before intubation, after intubation during 10 minutes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Videolaryngoscopes in Open Heart Surgery
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : March 20, 2019
Actual Study Completion Date : March 21, 2019

Arm Intervention/treatment
Active Comparator: heart rate
Effects of İntubation with Airtraq or Storz to heart rate
Device: airtraq
airtraq videolaryngoscope

Device: storz
storz videolaryngoscope

Active Comparator: mean arterial pressure
Effect of intubation with Airtraq or Storz to mean arterial pressure
Device: airtraq
airtraq videolaryngoscope

Device: storz
storz videolaryngoscope




Primary Outcome Measures :
  1. heart rate [ Time Frame: 2 months ]
    heart rate


Secondary Outcome Measures :
  1. insertion time [ Time Frame: 2 months ]
    optimal glottic visualisation time

  2. intubation time [ Time Frame: 2 months ]
    intubation time

  3. mean arterial pressure [ Time Frame: 2 months ]
    mean arterial pressure



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing open heart surgery
  • < 18 years of age

Exclusion Criteria:

  • emergency

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): NCT03483285


Locations
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Turkey
Kocaeli University Hospital
Kocaeli, Turkey
Sponsors and Collaborators
Kocaeli University
Investigators
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Principal Investigator: Tulay Cardakozu Anesthesiology and Reanimation

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Responsible Party: Tülay Çardaközü, Associate Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT03483285    
Other Study ID Numbers: KOU-KAEK 2017-405
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tülay Çardaközü, Kocaeli University:
intubation
airtraq
open heart surgery
hemodynamic parameters