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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
130
Size decided upon gender.
Size decided upon gender.
Rigshospitalet
Copenhagen, Denmark
Postoperative hoarseness
Time frame: 1 hr postoperatively
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
Only for the subgroup of patients with persisting hoarseness
Time frame: 72 hours postoperatively
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
Only for the subgroup of patients with persisting hoarseness
Time frame: After 4 weeks
Vocal cord sequelae
Time frame: Within 24 hr postoperatively
Vocal cord sequelae
Only for the subgroup of patients with persisting hoarseness
Time frame: 72 hours postoperatively
Vocal cord sequelae
Only for the subgroup of patients with persisting hoarseness
Time frame: After 4 weeks
Multi Dimensional Voice Profile
Time frame: Within 24 hr postoperatively
Multi Dimensional Voice Profile
Only for the subgroup of patients with persisting hoarseness
Time frame: 72 hours postoperatively
Multi Dimensional Voice Profile
Only for the subgroup of patients with persisting hoarseness
Time frame: After 4 weeks
Voice Handicap Index
Only for the subgroup of patients with persisting hoarseness
Time frame: After 4 weeks
Voice Handicap Index
Only for the subgroup of patients with persisting hoarseness
Time frame: 72 hr postoperatively
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