Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet

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

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-08-31

Brief Summary

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This study is aimed at reducing the risk of hoarseness and damage to the vocal cords following general anaesthesia. Conventional endotracheal intubation with use of a stylet will be compared with the Endoflex tube. A conventional stylet enforced endotracheal tube is dirigible because of the stiffness gained by the addition of a stylet. In high risk rapid sequence intubation settings the enhanced dirigibility can be crucial, which is why most anaesthesiologists choose to add the stylet in these situations. A new endotracheal tube with a dynamic dirigible end called the Endoflex tube might prove to be a good alternative to the conventional stylet enforced endotracheal tube.

Study hypothesis: The Endoflex tube will reduce the risk of hoarseness after intubation when compared to the conventional stylet enforced endotracheal tube under optimal intubation conditions.

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Detailed Description

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Conditions

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Intubation Complication Anaesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Endoflex tube

Use of Endoflex tube for intubation.

Group Type EXPERIMENTAL

Endoflex tube

Intervention Type DEVICE

Size decided upon gender.

Endotracheal tube with stylet

Use of conventional endotracheal tube with a stylet for intubation.

Group Type ACTIVE_COMPARATOR

Polyvinyl chloride endotracheal tube with a stylet

Intervention Type DEVICE

Size decided upon gender.

Interventions

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Endoflex tube

Size decided upon gender.

Intervention Type DEVICE

Polyvinyl chloride endotracheal tube with a stylet

Size decided upon gender.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Elective surgical patients who require an endotracheal tube during general anaesthesia.
* Informed consent.
* Legally competent.
* Be able to understand Danish and be able to read the given information in Danish.

Exclusion Criteria

* Planned or former operation in or around the pharynx or the larynx.
* Cancer, infection or sequelae in or around the pharynx or the larynx.
* Use of a stomach tube before or during surgery.
* Suspected difficult intubation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No