Anesthesia for Awake Fiberoptic Intubation

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation
• Intervention / Treatment: Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Sachsen
    • Leipzig, Sachsen, Germany, 04129
      • Klinikum St. Georg gGmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: translaryngeal injection; translaryngeal injection of local anesthetics before the awake intubation	Procedure: awake intubation; two anesthesia techniques
ACTIVE_COMPARATOR: spray as you go; local anesthetics are given through the fiberoptic during awake intubation	Procedure: awake intubation; two anesthesia techniques

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	Time Frame
pain after anesthesia	Change from Baseline in pain after anesthesia at end of hospital stay

Collaborators and Investigators

• Sponsor: Klinikum St. Georg gGmbH
• Investigators: Study Chair: Armin R Sablotzki, MD, Clinics of Anesthesiology, Critical care and Pain Therapy; Principal Investigator: Michael Malcharek, MD, Clinic of Anesthesiology, Dept. Neuroanesthesia and Neuromonitoring

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: July 27, 2009
• First Submitted That Met QC Criteria: July 28, 2009
• First Posted (ESTIMATE): July 29, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 20, 2015
• Last Update Submitted That Met QC Criteria: April 17, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: awake intubation; cervical instability; laryngeal anesthesia
• Other Study ID Numbers: EK-BR-34/08-1; Stu08/0041