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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03226002
Other study ID # KÜ GOKAEK 2017/71
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2017
Est. completion date September 10, 2017

Study information

Verified date August 2018
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

After Ethics committee approval investigators decided to enroll 40 patients ASA I-II, 18-60 years of age undergoing maxillofascial, oral and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. We primay aimed to compare the glottis visualization time, intubation time and total intubation times.


Description:

After Ethics committee approval, investigators decided to enroll 40 pateints ASA I-II, 18-60 years of age undergoing maxillofascial, oral and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. In addition is the 90° anti-clockwise rotation of the tip of the tube helpful to insert the tube into the trachea. Patients were randomized into right and the left nostril groups. After standard anesthesia induction with propofol and fentanyl, rocuronium was used for muscle relaxation. Primary aim of this prospective study was to compare the glottis visualization time, intubation time and total intubation times. The Cormack-Lehane grades, the need for optimization, tube adjustment maneuvers, hemodynamic data, occurrence of epistaxis of the patients were recorded during the process.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date September 10, 2017
Est. primary completion date September 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 18-65 years of age

- undergoing elective maxillofacial surgery

- dental surgery

- plastic surgery requiring nasotracheal intubation

- ASA I-II

Exclusion Criteria:

- >18 years and > 65 years

- BMI> 35

- ASA III-IV

- fasted patients

- patients do not require nasotracheal intubation

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Airtraq NT
channeled video laryngoscope for nasotracheal intubation

Locations

Country Name City State
Turkey Kocaeli University School of Medicine Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary insertion time of the device handling the device till the optimal glottis visualization occurred 20 seconds
Primary nasotracheal intubation time with the device handling the device till the visualization of tracheal tube through the vocal cords 30 seconds
Primary total nasotracheal intubation time with the device handling the device till the confirmation of nasotracheal intubation with end-tidal carbodioxide 40 seconds
Secondary optimisation maneuvers during intubation with the device need for optimisation maneuvers during nasotracheal intubation 20 seconds
Secondary minor complications related to the device epistaxis, nose pain, bronchospasm 40 seconds
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