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Comparison of Disposcope Endoscope and Fiberoptic Bronchoscope

NCT ID: NCT02669550

Last Updated: 2017-09-26

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-10-31

Brief Summary

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The fiberoptic bronchoscope (FOB) has been the preferred instrument for many years in the management of difficult tracheal intubation, and it is considered as a gold standard. The disposcope endoscope (DE) is a medical device for endotracheal intubation used in clinical practice recently.This study compares FOB and DE for awake orotracheal intubation in obese patients with anticipated difficult airway.

Detailed Description

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Forty obese patients with anticipated difficult airways were randomised to undergo awake orotracheal intubation by FOB(group F) or DE(group D) after conscious sedation. The conditions of orotracheal intubation, the time needed to view the vocal cords and to complete the orotracheal intubation, the hemodynamic changes and the adverse events including bradycardia, respiratory depression during orotracheal intubation, throat pain, hoarseness and memory after surgery were recorded. The ease of view the vocal cords and passing the tracheal tube through the glottis were also evaluated by using a visual analogue scale (VAS) by operator.

Conditions

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Therapeutic Procedural Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fiberoptic bronchoscope

In case of FOB, the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB

Group Type EXPERIMENTAL

Fiberoptic bronchoscope

Intervention Type DEVICE

In case of FOB, the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB

Disposcope endoscope

In the DE group, the operator gripped the chin and lower incisors of patients with the fingers and thumb to open the mouth adequately wide and grasped the wire body, which was enclosed within the endotracheal tube, by the other hand and held it parallel to,then inserted into oral cavity

Group Type EXPERIMENTAL

Disposcope endoscope

Intervention Type DEVICE

In the DE group, the operator gripped the chin and lower incisors of patients with the fingers and thumb to open the mouth adequately wide and grasped the wire body, which was enclosed within the endotracheal tube, by the other hand and held it parallel to,then inserted into oral cavity

Interventions

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Fiberoptic bronchoscope

In case of FOB, the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB

Intervention Type DEVICE

Disposcope endoscope

In the DE group, the operator gripped the chin and lower incisors of patients with the fingers and thumb to open the mouth adequately wide and grasped the wire body, which was enclosed within the endotracheal tube, by the other hand and held it parallel to,then inserted into oral cavity

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA classifications of I-II, modified Mallampati classification of 3 or 4, requiring general anesthesia were included.

Exclusion Criteria

* ASA class IV or V,
* Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Hospital of Qinhuangdao

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ximing Qi, PHD

Role: STUDY_DIRECTOR

The First Hospital of Qinhuangdao

Other Identifiers

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0001

Identifier Type: -

Identifier Source: org_study_id