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NCT03709524 Clinical Trial

Orotracheal Intubation in Adult Patients: A Comparison of Standard Airtraq , Nasotracheal Airtraq Combined With a Stylet Inserted Endotracheal Tube and Standard Airtraq Combined Fiberoptic Intubation

Difficult Intubation Clinical Trial

Official title:
A Comparison of Airtraq and Nasotracheal Airtraq for Orotracheal Intubation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03709524
Other study ID # KIA 2018/446
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date February 20, 2019

Study information
Verified date June 2019
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Adult patients requiring endotracheal intubation divided into three groups; standard Airtraq, Nasotracheal Airtraq + styletted endotracheal tube and Airtraq + fiberoptic combination groups.

Description:

We enroll lean adult patients requiring endotracheal intubation. Using a sealed envelope technique they divided into three groups; Standard Airtraq and Nasotracheal Airtraq + styletted endotracheal tube and Standard Airtraq + fiberoptic combination. Demographic characteristics and airway management variables such; age, gender, height, weight, ASA status, tooth morphology, tiro mental and sternomental distance were recorded. Insertion times, intubation times and total intubation times with these devices will be recorded. Hemodynamic parameters recorded such as; heart rate will be recorded baseline , after anesthesia, after insertion, just after and then every 2 minutes intervals after intubation. sore throat, hoarseness, dysphasia, bronchospasm were also recorded postoperatively.

Recruitment information / eligibility
Status Completed
Enrollment 119
Est. completion date February 20, 2019
Est. primary completion date February 20, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- BMI<30

- > 18 AGE

- requiring endotracheal intubation

- ASA 1-2

Exclusion Criteria:

- BMI> 30

- < 18 AGE

- ASA III-IV

- upper respiratory infection past ten days

- pregnant

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Airtraq + fiberoptic
video laryngoscope with a monitor
• Airtraq
video laryngoscope with a monitor
• Nasotracheal Airtraq + styletted tube
video laryngoscope with a monitor

Locations
Country Name City State
Turkey Kocaeli University Medical Faculty Kocaeli

Sponsors (1)
Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intubation time entering the oral cavity till intubation 6 months
Secondary insertion time entering the oral cavity till the optimal visualization 6 months
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