Clinical trial NCT00953433: Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet
Official title: Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Complication
Anaesthesia
Keywords: Intratracheal
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
First posted: 2009-08-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Postoperative hoarseness
timeFrame: 1 hr postoperatively
Secondary outcomes:
measure: Vocal cord sequelae
timeFrame: Preoperative - on average 12 hours before operation
measure: Intubation conditions
timeFrame: During and after intubation - on average 5 minutes
measure: Intubation difficulty scale
timeFrame: During and after intubation - on average 5 minutes
measure: Voice Range Profile
timeFrame: 72 hours postoperatively
measure: Multi Dimensional Voice Profile
timeFrame: Preoperative - on average 12 hours before operation
measure: Voice Handicap Index
timeFrame: Preoperative - on average 12 hours before operation
measure: Voice Range Profile
timeFrame: After 4 weeks
measure: Vocal cord sequelae
timeFrame: Within 24 hr postoperatively
measure: Vocal cord sequelae
timeFrame: 72 hours postoperatively
measure: Vocal cord sequelae
timeFrame: After 4 weeks
measure: Multi Dimensional Voice Profile
timeFrame: Within 24 hr postoperatively
measure: Multi Dimensional Voice Profile
timeFrame: 72 hours postoperatively
measure: Multi Dimensional Voice Profile
timeFrame: After 4 weeks
measure: Voice Handicap Index
timeFrame: After 4 weeks
measure: Voice Handicap Index
timeFrame: 72 hr postoperatively
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lars Rasmussen, MD, PHD
role: STUDY_CHAIR
References: