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

NCT00953433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2011-08-24

No results posted yet for this study

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.

Conditions

  • Intubation Complication
  • Anaesthesia

Interventions

DEVICE

Endoflex tube

Size decided upon gender.

DEVICE

Polyvinyl chloride endotracheal tube with a stylet

Size decided upon gender.

Sponsors & Collaborators

  • TrygFonden, Denmark

    collaborator INDUSTRY

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Lars Rasmussen, MD, PHD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00953433 on ClinicalTrials.gov