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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00953433
First Posted: August 6, 2009
Last Update Posted: August 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
TrygFonden, Denmark
Information provided by (Responsible Party):
Martin Kryspin Soerensen, Rigshospitalet, Denmark
August 5, 2009
August 6, 2009
August 24, 2011
April 2010
August 2011   (Final data collection date for primary outcome measure)
Postoperative hoarseness [ Time Frame: 1 hr postoperatively ]
Same as current
Complete list of historical versions of study NCT00953433 on ClinicalTrials.gov Archive Site
  • Vocal cord sequelae [ Time Frame: Preoperative - on average 12 hours before operation ]
  • Intubation conditions [ Time Frame: During and after intubation - on average 5 minutes ]
  • Intubation difficulty scale [ Time Frame: During and after intubation - on average 5 minutes ]
  • Voice Range Profile [ Time Frame: 72 hours postoperatively ]
    Only for the subgroup of patients with persisting hoarseness
  • Multi Dimensional Voice Profile [ Time Frame: Preoperative - on average 12 hours before operation ]
  • Voice Handicap Index [ Time Frame: Preoperative - on average 12 hours before operation ]
  • Voice Range Profile [ Time Frame: After 4 weeks ]
    Only for the subgroup of patients with persisting hoarseness
  • Vocal cord sequelae [ Time Frame: Within 24 hr postoperatively ]
  • Vocal cord sequelae [ Time Frame: 72 hours postoperatively ]
    Only for the subgroup of patients with persisting hoarseness
  • Vocal cord sequelae [ Time Frame: After 4 weeks ]
    Only for the subgroup of patients with persisting hoarseness
  • Multi Dimensional Voice Profile [ Time Frame: Within 24 hr postoperatively ]
  • Multi Dimensional Voice Profile [ Time Frame: 72 hours postoperatively ]
    Only for the subgroup of patients with persisting hoarseness
  • Multi Dimensional Voice Profile [ Time Frame: After 4 weeks ]
    Only for the subgroup of patients with persisting hoarseness
  • Voice Handicap Index [ Time Frame: After 4 weeks ]
    Only for the subgroup of patients with persisting hoarseness
  • Voice Handicap Index [ Time Frame: 72 hr postoperatively ]
    Only for the subgroup of patients with persisting hoarseness
  • Vocal cord sequelae [ Time Frame: Preoperatively and within 24 hr postoperatively ]
  • Intubation conditions [ Time Frame: Upon intubation ]
  • Intubation difficulty scale [ Time Frame: Upon intubation ]
  • Voice Range Profile (only for the subgroup of patients with persisting hoarseness) [ Time Frame: 72 hours postoperatively and after 4 weeks ]
  • Multi Dimensional Voice Profile [ Time Frame: Preoperatively and within 24 hr postoperatively ]
  • Voice Handicap Index [ Time Frame: Preoperatively and after 72 hours ]
Not Provided
Not Provided
 
Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet
Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Intubation Complication
  • Anaesthesia
  • Device: Endoflex tube
    Size decided upon gender.
  • Device: Polyvinyl chloride endotracheal tube with a stylet
    Size decided upon gender.
  • Experimental: Endoflex tube
    Use of Endoflex tube for intubation.
    Intervention: Device: Endoflex tube
  • Active Comparator: Endotracheal tube with stylet
    Use of conventional endotracheal tube with a stylet for intubation.
    Intervention: Device: Polyvinyl chloride endotracheal tube with a stylet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
August 2011
August 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00953433
Endoflex-Stylet
No
Not Provided
Not Provided
Martin Kryspin Soerensen, Rigshospitalet, Denmark
Rigshospitalet, Denmark
TrygFonden, Denmark
Study Chair: Lars Rasmussen, MD, PHD Rigshospitalet, Denmark
Rigshospitalet, Denmark
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP