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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

August 5, 2009
August 23, 2011
April 2010
August 2011   (final data collection date for primary outcome measure)
Postoperative hoarseness [ Time Frame: 1 hr postoperatively ] [ Designated as safety issue: No ]
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 ] [ 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
  • Vocal cord sequelae [ Time Frame: Preoperatively and within 24 hr postoperatively ] [ Designated as safety issue: No ]
  • Intubation conditions [ Time Frame: Upon intubation ] [ Designated as safety issue: No ]
  • Intubation difficulty scale [ Time Frame: Upon intubation ] [ Designated as safety issue: No ]
  • Voice Range Profile (only for the subgroup of patients with persisting hoarseness) [ Time Frame: 72 hours postoperatively and after 4 weeks ] [ Designated as safety issue: No ]
  • Multi Dimensional Voice Profile [ Time Frame: Preoperatively and within 24 hr postoperatively ] [ Designated as safety issue: No ]
  • Voice Handicap Index [ Time Frame: Preoperatively and after 72 hours ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00953433
Endoflex-Stylet
No
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