Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet

Study Overview
=================
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.

Official Title
-----------------
Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet

Conditions
-----------------
Intubation Complication, Anaesthesia

Intervention / Treatment
-----------------
* Device: Endoflex tube
* Device: Polyvinyl chloride endotracheal tube with a stylet


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoflex tube<br>Use of Endoflex tube for intubation. | Device: Endoflex tube<br>* Size decided upon gender.<br>|
| Active Comparator: Endotracheal tube with stylet<br>Use of conventional endotracheal tube with a stylet for intubation. | Device: Polyvinyl chloride endotracheal tube with a stylet<br>* Size decided upon gender.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hoarseness |  | 1 hr postoperatively | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intratracheal