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

Sponsor
Kocaeli University (Other)
Overall Status
Completed
CT.gov ID
NCT03483285
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
11.6
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: airtraq
  • Device: storz
 N/A

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.

Study Design

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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. heart rate [2 months]

    heart rate

Secondary Outcome Measures

  1. insertion time [2 months]

    optimal glottic visualisation time

  2. intubation time [2 months]

    intubation time

  3. mean arterial pressure [2 months]

    mean arterial pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • patients undergoing open heart surgery

  • < 18 years of age

Exclusion Criteria:
  • emergency

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kocaeli University Hospital Kocaeli Turkey

Sponsors and Collaborators

  • Kocaeli University

Investigators

  • Principal Investigator: Tulay Cardakozu, Anesthesiology and Reanimation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tülay Çardaközü, Associate Professor, Kocaeli University
ClinicalTrials.gov Identifier:
NCT03483285
Other Study ID Numbers:
  • KOU-KAEK 2017-405
First Posted:
Mar 30, 2018
Last Update Posted:
Feb 17, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tülay Çardaközü, Associate Professor, Kocaeli University
intubation
airtraq
open heart surgery
hemodynamic parameters

Study Results

No Results Posted as of Feb 17, 2021