Anesthesia for Awake Fiberoptic Intubation

NCT ID: NCT00948350

Last Updated: 2015-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-01-31

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.

Conditions

Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

translaryngeal injection

translaryngeal injection of local anesthetics before the awake intubation

Group Type: ACTIVE_COMPARATOR

awake intubation

Intervention Type: PROCEDURE

two anesthesia techniques

spray as you go

local anesthetics are given through the fiberoptic during awake intubation

Group Type: ACTIVE_COMPARATOR

awake intubation

Intervention Type: PROCEDURE

two anesthesia techniques

Interventions

awake intubation

two anesthesia techniques

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Klinikum St. Georg gGmbH

OTHER

Sponsor Role: lead

Responsible Party

Armin Sablotzki, MD

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Armin R Sablotzki, MD

Role: STUDY_CHAIR

Clinics of Anesthesiology, Critical care and Pain Therapy

Michael Malcharek, MD

Role: PRINCIPAL_INVESTIGATOR

Clinic of Anesthesiology, Dept. Neuroanesthesia and Neuromonitoring

Locations

Klinikum St. Georg gGmbH

Leipzig, Saxony, Germany

Countries

Germany

References

Malcharek MJ, Bartz M, Rogos B, Gunther L, Sablotzki A, Gille J, Schneider G. Comparison of Enk Fibreoptic Atomizer with translaryngeal injection for topical anaesthesia for awake fibreoptic intubation in patients at risk of secondary cervical injury: A randomised controlled trial. Eur J Anaesthesiol. 2015 Sep;32(9):615-23. doi: 10.1097/EJA.0000000000000285.

Reference Type: DERIVED

PMID: 26086284 (View on PubMed)

Other Identifiers

Stu08/0041

Identifier Type: -

Identifier Source: secondary_id

EK-BR-34/08-1

Identifier Type: -

Identifier Source: org_study_id