NCT03483285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2019

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

12 months

First QC Date

March 15, 2018

Last Update Submit

February 15, 2021

Conditions

Intubation;DifficultCoronary Bypass

Keywords

intubationairtraqopen heart surgeryhemodynamic parameters

Outcome Measures

Primary Outcomes (1)

  • heart rate

    heart rate

    2 months

Secondary Outcomes (3)

  • insertion time

    2 months

  • intubation time

    2 months

  • mean arterial pressure

    2 months

Study Arms (2)

heart rate

ACTIVE COMPARATOR

Effects of İntubation with Airtraq or Storz to heart rate

Device: airtraqDevice: storz

mean arterial pressure

ACTIVE COMPARATOR

Effect of intubation with Airtraq or Storz to mean arterial pressure

Device: airtraqDevice: storz

Interventions

airtraqDEVICE

airtraq videolaryngoscope

heart ratemean arterial pressure
storzDEVICE

storz videolaryngoscope

heart ratemean arterial pressure

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • emergency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Hospital

Kocaeli, Turkey (Türkiye)

Location

Study Officials

  • Tulay Cardakozu

    Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 30, 2018

Study Start

April 1, 2018

Primary Completion

March 20, 2019

Study Completion

March 21, 2019

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations

TU(1)