- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03483285
Comparison of Two Different Videolaryngoscopes Regarding Hemodynamic Parameters in Open Heart Surgey
Videolaryngoscopes in Open Heart Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kocaeli, Turkey
- Kocaeli University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients undergoing open heart surgery
- < 18 years of age
Exclusion Criteria:
- emergency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: heart rate
Effects of İntubation with Airtraq or Storz to heart rate
|
airtraq videolaryngoscope
storz videolaryngoscope
|
ACTIVE_COMPARATOR: mean arterial pressure
Effect of intubation with Airtraq or Storz to mean arterial pressure
|
airtraq videolaryngoscope
storz videolaryngoscope
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
heart rate
Time Frame: 2 months
|
heart rate
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
insertion time
Time Frame: 2 months
|
optimal glottic visualisation time
|
2 months
|
intubation time
Time Frame: 2 months
|
intubation time
|
2 months
|
mean arterial pressure
Time Frame: 2 months
|
mean arterial pressure
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tulay Cardakozu, Anesthesiology and Reanimation
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KOU-KAEK 2017-405
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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