Anaesthesia, Intubation Complication
Conditions
Keywords
Intratracheal
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.
Interventions
DEVICEEndoflex tube
Size decided upon gender.
DEVICEPolyvinyl chloride endotracheal tube with a stylet
Size decided upon gender.
Sponsors
TrygFonden, Denmark
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative hoarseness | 1 hr postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vocal cord sequelae | Preoperative - on average 12 hours before operation | — |
| Intubation conditions | During and after intubation - on average 5 minutes | — |
| Intubation difficulty scale | During and after intubation - on average 5 minutes | — |
| Multi Dimensional Voice Profile | Preoperative - on average 12 hours before operation | — |
| Voice Handicap Index | Preoperative - on average 12 hours before operation | — |
| Voice Range Profile | 72 hours postoperatively | Only for the subgroup of patients with persisting hoarseness |
Countries
Denmark
Outcome results
None listed