Which Nostril Should be Used for Nasotracheal Intubation With Airtraq NT®: the Right or Left? A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Nasotracheal Intubation
• Intervention / Treatment: Device: Airtraq NT

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey, 41900
    • Kocaeli University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Airtraq NT right nostril; nasotracheal intubation with Airtraq NT through the right nostril	Device: Airtraq NT; channeled video laryngoscope for nasotracheal intubation
Active Comparator: Airtraq NT left nostril; nasotracheal intubation with Airtraq NT through the left nostril	Device: Airtraq NT; channeled video laryngoscope for nasotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insertion time of the device	handling the device till the optimal glottis visualization occurred	20 seconds
nasotracheal intubation time with the device	handling the device till the visualization of tracheal tube through the vocal cords	30 seconds
total nasotracheal intubation time with the device	handling the device till the confirmation of nasotracheal intubation with end-tidal carbodioxide	40 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
optimisation maneuvers during intubation with the device	need for optimisation maneuvers during nasotracheal intubation	20 seconds
minor complications related to the device	epistaxis, nose pain, bronchospasm	40 seconds

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Principal Investigator: zehra I Arslan, Anesthesiology and Reanimation

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 10, 2017

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: left; nasotracheal intubation; right; Airtraq NT
• Other Study ID Numbers: KÜ GOKAEK 2017/71

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No