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

Not Applicable

Completed

• Conditions: Intubation Complication; Anaesthesia
• Interventions: Device: Endoflex tube; Device: Polyvinyl chloride endotracheal tube with a stylet

• Registration Number: NCT00953433
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Study Start: 2010-04
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-23
• Last Update Posted: 2011-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoflex tube	Endoflex tube	Use of Endoflex tube for intubation.
Endotracheal tube with stylet	Polyvinyl chloride endotracheal tube with a stylet	Use of conventional endotracheal tube with a stylet for intubation.

Primary Outcome Measures

Name	Time	Method
Postoperative hoarseness	1 hr postoperatively

Secondary Outcome Measures

Name	Time	Method
Vocal cord sequelae	After 4 weeks	Only for the subgroup of patients with persisting hoarseness
Intubation conditions	During and after intubation - on average 5 minutes
Intubation difficulty scale	During and after intubation - on average 5 minutes
Voice Range Profile	After 4 weeks	Only for the subgroup of patients with persisting hoarseness
Multi Dimensional Voice Profile	After 4 weeks	Only for the subgroup of patients with persisting hoarseness
Voice Handicap Index	72 hr postoperatively	Only for the subgroup of patients with persisting hoarseness

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark