Anesthesia for Awake Fiberoptic Intubation

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948350
• Other study ID #: EK-BR-34/08-1
• Secondary ID: Stu08/0041
• Status: Completed
• Phase: N/A
• First received: July 27, 2009
• Last updated: April 17, 2015
• Start date: January 2009
• Est. completion date: January 2014

Study information

• Verified date: April 2015
• Source: Klinikum St. Georg gGmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Intubation

Intervention

Procedure:
• awake intubation
two anesthesia techniques

Locations

Country	Name	City	State
Germany	Klinikum St. Georg gGmbH	Leipzig	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum St. Georg gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	pain after anesthesia		Change from Baseline in pain after anesthesia at end of hospital stay	No