Anesthesia for Awake Fiberoptic Intubation

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Klinikum St. Georg gGmbH
Sponsor:
Information provided by (Responsible Party):
Armin Sablotzki, MD, Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier:
NCT00948350
First received: July 27, 2009
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Intubation
Procedure: awake intubation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Anesthesia for Awake Fiberoptic Intubation in Patients With Cervical Instability - Comparison of Translaryngeal Injection and "Spray as You go"-Technique

Further study details as provided by Klinikum St. Georg gGmbH:

Primary Outcome Measures:
  • patients satisfaction with anesthesia [ Time Frame: up to two weeks after hospital admission ] [ Designated as safety issue: No ]
    participants will be followed for the duration of hospital stay, an expected average of 2 weeks


Secondary Outcome Measures:
  • pain after anesthesia [ Time Frame: Change from Baseline in pain after anesthesia at end of hospital stay ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948350

Contacts
Contact: Michael Malcharek, MD 0049-(0)341-9094009 michael.malcharek@sanktgeorg.de
Contact: Armin R Sablotzki, MD, PhD 0049-(0)341-9092570 armin.sablotzki@sanktgeorg.de

Locations
Germany
Klinikum St. Georg gGmbH Recruiting
Leipzig, Sachsen, Germany, 04129
Contact: Michael Malcharek, MD    0049-(0)341-9094009    michael.malcharek@sanktgeorg.de   
Principal Investigator: Michael Malcharek, MD         
Sub-Investigator: Birgit Rogos, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Armin Sablotzki, MD, Prof. Dr. med., Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier: NCT00948350     History of Changes
Other Study ID Numbers: EK-BR-34/08-1, Stu08/0041
Study First Received: July 27, 2009
Last Updated: July 12, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Klinikum St. Georg gGmbH:
cervical instability
awake intubation
laryngeal anesthesia

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014