Evaluation of the Single Use Flexible Optical Scope Versus Multiple Use Flexible Optical Scopes for Intubation

NCT ID: NCT01100957

Last Updated: 2011-08-24

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-12-31

Brief Summary

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The study is in two parts

Part one of the study describes the use of the new single-use flexible video-scope for intubation of patients with predicted normal airways.

Part two compares the performance of the single-use flexible video-scope with that of a conventional flexible video-scope for awake intubation of patients with predicted difficult airways.

The hypothesis is that the new single-use flexible video-scope for intubation performs as well as the traditional scope.

Detailed Description

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Conditions

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Tracheal Intubation Difficult Airway

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional flexible videoscope for intubation

Group Type ACTIVE_COMPARATOR

tracheal intubation with a single use flexible videoscope

Intervention Type PROCEDURE

tracheal intubation with a single use flexible videoscope

Single-patient flexible endoscope

Single-patient flexible video-endoscope used for tracheal intubation in this intervention-arm

Group Type EXPERIMENTAL

tracheal intubation with a single use flexible videoscope

Intervention Type PROCEDURE

tracheal intubation with a single use flexible videoscope

Interventions

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tracheal intubation with a single use flexible videoscope

tracheal intubation with a single use flexible videoscope

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Study part 1:

* Patients scheduled for tracheal intubation and predicted to have a normal airway
* ASA class I, II or III
* \>18 years
2. Study part 2:

* Adult patients scheduled for tracheal intubation and predicted to have a difficult airway
* ASA class I, II or III
* \>18 years

Exclusion Criteria

1. Study part 1:

* Massive bleeding from the mouth
* Previously abandoned flexible optical intubation
2. Study part 2:

* Massive bleeding from the mouth
* Previously abandoned flexible optical intubation
* Patients with audible stridor
* Patients with dyspnea
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Michael Seltz Kristensen

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael S Kristensen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-A-2009-022

Identifier Type: -

Identifier Source: secondary_id

aScope-1+2 a

Identifier Type: -

Identifier Source: org_study_id

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