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CompletedNCT03483285Updated Feb 17, 2021

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

An interventional study of airtraq and storz in Intubation;Difficult and Coronary Bypass, sponsored by Kocaeli University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-02-17.

Sponsored by Kocaeli University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intubation;Difficult
  • Coronary Bypass

Keywords

  • intubation
  • airtraq
  • open heart surgery
  • hemodynamic parameters
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • emergency
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    heart rate

    Effects of İntubation with Airtraq or Storz to heart rate

    Device: airtraq · Device: storz

  • Active comparator
    mean arterial pressure

    Effect of intubation with Airtraq or Storz to mean arterial pressure

    Device: airtraq · Device: storz

Interventions

  • Deviceairtraq

    airtraq videolaryngoscope

  • Devicestorz

    storz videolaryngoscope

05

What researchers measure

Primary outcomes

  1. heart rate

    heart rate

    Time frame: 2 months

Secondary outcomes

  1. insertion time

    optimal glottic visualisation time

    Time frame: 2 months

  2. intubation time

    intubation time

    Time frame: 2 months

  3. mean arterial pressure

    mean arterial pressure

    Time frame: 2 months

06

Study locations

1 site
  • Kocaeli University Hospital
    Kocaeli, Turkey
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03483285
Lead sponsor
Kocaeli University
Responsible party
Tülay Çardaközü (Associate Professor, Kocaeli University) — Principal investigator
First posted
Mar 30, 2018
Start date
Apr 1, 2018
Primary completion
Mar 20, 2019
Completion
Mar 21, 2019
Last update
Feb 17, 2021

Study contacts

Tulay Cardakozu
principal investigator · Anesthesiology and Reanimation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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