Tongue Root Retractor For Fibroscopic Intubation

NCT ID: NCT04343014

Last Updated: 2021-02-10

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-10

Study Completion Date

2020-12-10

Brief Summary

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Patients admit to the operation rooms of First Affiliated Hospital of Nanjing Medical University and requiring endotracheal intubation for general anesthesia will be enrolled in this case controlled study.

Patients 1) aged 18 to 70 years; 2) ASA graded I\~II class; 3) general anesthesia should be performed under endotracheal intubation, will be included from this study. Patients 1) with organ transplant operations; 2) with thoracic and cardiac vascular surgery; 3) with severe heart or lung disease; 4) BMI over 35kg/m2, will be excluded from this study.

The primary aim is to compare airway clearance for fibreoptic tracheal intubation in each patient position. Secondary outcomes include times to view the vocal cord and carina, the time for tube advancement through the vocal cords, as well as the total time to achieve tracheal intubation.Two anesthesiologists with 5 years of experience in conventional endotracheal intubation and trained for fibreoptic intubation will perform the maneuvers.

Detailed Description

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Conditions

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Airway Management

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tongue Root Retractor

Patients in this arm will receive fibroscopic endotracheal intubation with tongue root retractors.

Group Type EXPERIMENTAL

Tongue Root Retractor

Intervention Type DEVICE

Fibroptic endutracheal intubation will be performed with tongue root retractor.

Conventional Fibroscope

Patients in this arm will receive fibroscopic endotracheal intubation without any other devices.

Group Type ACTIVE_COMPARATOR

Conventional Fibroscope

Intervention Type DEVICE

Fibroptic endutracheal intubation will be performed in conventional way.

Interventions

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Tongue Root Retractor

Fibroptic endutracheal intubation will be performed with tongue root retractor.

Intervention Type DEVICE

Conventional Fibroscope

Fibroptic endutracheal intubation will be performed in conventional way.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* aged 18 to 70 years
* ASA graded I\~II class
* scheduled for elective surgery requiring orotracheal intubation

Exclusion Criteria

* with organ transplant operations
* with thoracic and cardiac vascular surgery
* with severe cadiac or pulmonary disease
* BMI over 35kg/m2
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhengnian Ding, M.D.

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Xiaofei Cao, M.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Junbei Wu, M.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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Fibroscopic intubation

Identifier Type: -

Identifier Source: org_study_id

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