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

Rigshospitalet

Status: Completed

Conditions: Anaesthesia; Intubation Complication

Treatments: Device: Polyvinyl chloride endotracheal tube with a stylet; Device: Endoflex tube

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00953433

Endoflex-Stylet

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups

Endoflex tube

Experimental group

Description:

Use of Endoflex tube for intubation.

Treatment:

Device: Endoflex tube

Endotracheal tube with stylet

Active Comparator group

Description:

Use of conventional endotracheal tube with a stylet for intubation.

Treatment:

Device: Polyvinyl chloride endotracheal tube with a stylet