Rigshospitalet
Copenhagen, 2100, Denmark
NCT Number: NCT00953433
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Copenhagen, 2100, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Size decided upon gender.
Size decided upon gender.
Time frame: 1 hr postoperatively
Time frame: Preoperative - on average 12 hours before operation
Time frame: During and after intubation - on average 5 minutes
Time frame: During and after intubation - on average 5 minutes
Time frame: 72 hours postoperatively
Only for the subgroup of patients with persisting hoarseness
Time frame: Preoperative - on average 12 hours before operation
Time frame: Preoperative - on average 12 hours before operation
Time frame: After 4 weeks
Only for the subgroup of patients with persisting hoarseness
Time frame: Within 24 hr postoperatively
Time frame: 72 hours postoperatively
Only for the subgroup of patients with persisting hoarseness
Time frame: After 4 weeks
Only for the subgroup of patients with persisting hoarseness
Time frame: Within 24 hr postoperatively
Time frame: 72 hours postoperatively
Only for the subgroup of patients with persisting hoarseness
Time frame: After 4 weeks
Only for the subgroup of patients with persisting hoarseness
Time frame: After 4 weeks
Only for the subgroup of patients with persisting hoarseness
Time frame: 72 hr postoperatively
Only for the subgroup of patients with persisting hoarseness
Rigshospitalet, Denmark
Other
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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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