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| Name | Class |
|---|---|
| TrygFonden, Denmark | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoflex tube | Experimental | Use of Endoflex tube for intubation. |
|
| Endotracheal tube with stylet | Active Comparator | Use of conventional endotracheal tube with a stylet for intubation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoflex tube | Device | Size decided upon gender. |
| |
| Polyvinyl chloride endotracheal tube with a stylet |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative hoarseness | 1 hr postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Vocal cord sequelae | Preoperative - on average 12 hours before operation | |
| Intubation conditions | During and after intubation - on average 5 minutes | |
| Intubation difficulty scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Rasmussen, MD, PHD | Rigshospitalet, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark |
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| Device |
Size decided upon gender. |
|
| During and after intubation - on average 5 minutes |
| Voice Range Profile | Only for the subgroup of patients with persisting hoarseness | 72 hours postoperatively |
| Multi Dimensional Voice Profile | Preoperative - on average 12 hours before operation |
| Voice Handicap Index | Preoperative - on average 12 hours before operation |
| Voice Range Profile | Only for the subgroup of patients with persisting hoarseness | After 4 weeks |
| Vocal cord sequelae | Within 24 hr postoperatively |
| Vocal cord sequelae | Only for the subgroup of patients with persisting hoarseness | 72 hours postoperatively |
| Vocal cord sequelae | Only for the subgroup of patients with persisting hoarseness | After 4 weeks |
| Multi Dimensional Voice Profile | Within 24 hr postoperatively |
| Multi Dimensional Voice Profile | Only for the subgroup of patients with persisting hoarseness | 72 hours postoperatively |
| Multi Dimensional Voice Profile | Only for the subgroup of patients with persisting hoarseness | After 4 weeks |
| Voice Handicap Index | Only for the subgroup of patients with persisting hoarseness | After 4 weeks |
| Voice Handicap Index | Only for the subgroup of patients with persisting hoarseness | 72 hr postoperatively |