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

NCT ID: NCT03226002

Last Updated: 2018-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-09-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Airtraq NT right nostril

nasotracheal intubation with Airtraq NT through the right nostril

Group Type ACTIVE_COMPARATOR

Airtraq NT

Intervention Type DEVICE

channeled video laryngoscope for nasotracheal intubation

Airtraq NT left nostril

nasotracheal intubation with Airtraq NT through the left nostril

Group Type ACTIVE_COMPARATOR

Airtraq NT

Intervention Type DEVICE

channeled video laryngoscope for nasotracheal intubation

Interventions

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Airtraq NT

channeled video laryngoscope for nasotracheal intubation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Zehra Ipek ARSLAN

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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zehra I Arslan

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology and Reanimation

Locations

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Kocaeli University School of Medicine

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KÜ GOKAEK 2017/71

Identifier Type: -

Identifier Source: org_study_id

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