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Completed

NCT Number: NCT00953433

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoflex tube

Device

Size decided upon gender.

Polyvinyl chloride endotracheal tube with a stylet

Device

Size decided upon gender.

Primary outcomes

  1. Postoperative hoarseness

    Time frame: 1 hr postoperatively

Secondary outcomes

  1. Vocal cord sequelae

    Time frame: Preoperative - on average 12 hours before operation

  2. Intubation conditions

    Time frame: During and after intubation - on average 5 minutes

  3. Intubation difficulty scale

    Time frame: During and after intubation - on average 5 minutes

  4. Voice Range Profile

    Time frame: 72 hours postoperatively

    Only for the subgroup of patients with persisting hoarseness

  5. Multi Dimensional Voice Profile

    Time frame: Preoperative - on average 12 hours before operation

  6. Voice Handicap Index

    Time frame: Preoperative - on average 12 hours before operation

  7. Voice Range Profile

    Time frame: After 4 weeks

    Only for the subgroup of patients with persisting hoarseness

  8. Vocal cord sequelae

    Time frame: Within 24 hr postoperatively

  9. Vocal cord sequelae

    Time frame: 72 hours postoperatively

    Only for the subgroup of patients with persisting hoarseness

  10. Vocal cord sequelae

    Time frame: After 4 weeks

    Only for the subgroup of patients with persisting hoarseness

  11. Multi Dimensional Voice Profile

    Time frame: Within 24 hr postoperatively

  12. Multi Dimensional Voice Profile

    Time frame: 72 hours postoperatively

    Only for the subgroup of patients with persisting hoarseness

  13. Multi Dimensional Voice Profile

    Time frame: After 4 weeks

    Only for the subgroup of patients with persisting hoarseness

  14. Voice Handicap Index

    Time frame: After 4 weeks

    Only for the subgroup of patients with persisting hoarseness

  15. Voice Handicap Index

    Time frame: 72 hr postoperatively

    Only for the subgroup of patients with persisting hoarseness

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • TrygFonden, Denmark

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 6, 2009
Registry last updated
Aug 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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