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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014