Anesthesia for Awake Fiberoptic Intubation

Study Overview
=================
Brief Summary
-----------------
This is a prospective, comparative, randomized, monocentric, clinical open study, to compare two anesthesia techniques (translaryngeal injection vs. spray as you go) in patients with cervical instability with regard to technical modalities and quality of fiberoptic awake intubation.

Detailed Description
-----------------
In patients with cervical instability anesthesia induction and conventional intubation are associated with the risk of neurological harm. Therefore the method of choice for anesthesia induction is the fiberoptic awake intubation. This method allows to place the ventilation tube without movement of the cervical spinal cord. This procedure is very uncomfortable for the patient and needs the application of topic and/or systemic anesthetics. With this clinical study we will compare two established techniques for local laryngeal anesthesia with regard to the quality of technical modalities and postoperative outcome.

Official Title
-----------------
Anesthesia for Awake Fiberoptic Intubation in Patients With Cervical Instability - Comparison of Translaryngeal Injection and Spray as You go-Technique

Conditions
-----------------
Intubation

Intervention / Treatment
-----------------
* Procedure: awake intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with cervical instability undergoing elective decompression of cervical spine Exclusion Criteria: patient refused participation contraindications for awake intubation techniques (e.g. nasal bleeding, anatomical disorders) patient under alcohol or drugs emergency surgery

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: translaryngeal injection<br>translaryngeal injection of local anesthetics before the awake intubation | Procedure: awake intubation<br>* two anesthesia techniques<br>|
| Active Comparator: spray as you go<br>local anesthetics are given through the fiberoptic during awake intubation | Procedure: awake intubation<br>* two anesthesia techniques<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients satisfaction with anesthesia | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | up to two weeks after hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain after anesthesia |  | Change from Baseline in pain after anesthesia at end of hospital stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical instability, awake intubation, laryngeal anesthesia