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

This study has been completed.
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by (Responsible Party):
Martin Kryspin Soerensen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00953433
First received: August 5, 2009
Last updated: August 23, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Intubation Complication
Anaesthesia
Device: Endoflex tube
Device: Polyvinyl chloride endotracheal tube with a stylet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Postoperative hoarseness [ Time Frame: 1 hr postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vocal cord sequelae [ Time Frame: Preoperative - on average 12 hours before operation ] [ Designated as safety issue: No ]
  • Intubation conditions [ Time Frame: During and after intubation - on average 5 minutes ] [ Designated as safety issue: No ]
  • Intubation difficulty scale [ Time Frame: During and after intubation - on average 5 minutes ] [ Designated as safety issue: No ]
  • Voice Range Profile [ Time Frame: 72 hours postoperatively ] [ Designated as safety issue: No ]
    Only for the subgroup of patients with persisting hoarseness

  • Multi Dimensional Voice Profile [ Time Frame: Preoperative - on average 12 hours before operation ] [ Designated as safety issue: No ]
  • Voice Handicap Index [ Time Frame: Preoperative - on average 12 hours before operation ] [ Designated as safety issue: No ]
  • Voice Range Profile [ Time Frame: After 4 weeks ] [ Designated as safety issue: No ]
    Only for the subgroup of patients with persisting hoarseness

  • Vocal cord sequelae [ Time Frame: Within 24 hr postoperatively ] [ Designated as safety issue: No ]
  • Vocal cord sequelae [ Time Frame: 72 hours postoperatively ] [ Designated as safety issue: No ]
    Only for the subgroup of patients with persisting hoarseness

  • Vocal cord sequelae [ Time Frame: After 4 weeks ] [ Designated as safety issue: No ]
    Only for the subgroup of patients with persisting hoarseness

  • Multi Dimensional Voice Profile [ Time Frame: Within 24 hr postoperatively ] [ Designated as safety issue: No ]
  • Multi Dimensional Voice Profile [ Time Frame: 72 hours postoperatively ] [ Designated as safety issue: No ]
    Only for the subgroup of patients with persisting hoarseness

  • Multi Dimensional Voice Profile [ Time Frame: After 4 weeks ] [ Designated as safety issue: No ]
    Only for the subgroup of patients with persisting hoarseness

  • Voice Handicap Index [ Time Frame: After 4 weeks ] [ Designated as safety issue: No ]
    Only for the subgroup of patients with persisting hoarseness

  • Voice Handicap Index [ Time Frame: 72 hr postoperatively ] [ Designated as safety issue: No ]
    Only for the subgroup of patients with persisting hoarseness


Enrollment: 130
Study Start Date: April 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endoflex tube
Use of Endoflex tube for intubation.
Device: Endoflex tube
Size decided upon gender.
Active Comparator: Endotracheal tube with stylet
Use of conventional endotracheal tube with a stylet for intubation.
Device: Polyvinyl chloride endotracheal tube with a stylet
Size decided upon gender.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953433

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
TrygFonden, Denmark
Investigators
Study Chair: Lars Rasmussen, MD, PHD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Martin Kryspin Soerensen, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00953433     History of Changes
Other Study ID Numbers: Endoflex-Stylet
Study First Received: August 5, 2009
Last Updated: August 23, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
Intratracheal

ClinicalTrials.gov processed this record on April 16, 2014