Anesthesia for Awake Fiberoptic Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00948350
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : April 20, 2015
Information provided by (Responsible Party):
Armin Sablotzki, MD, Klinikum St. Georg gGmbH

July 27, 2009
July 29, 2009
April 20, 2015
January 2009
January 2014   (Final data collection date for primary outcome measure)
patients satisfaction with anesthesia [ Time Frame: up to two weeks after hospital admission ]
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
patients satisfaction [ Time Frame: 1. postoperative day, 28. postoperative day ]
Complete list of historical versions of study NCT00948350 on Archive Site
pain after anesthesia [ Time Frame: Change from Baseline in pain after anesthesia at end of hospital stay ]
  • duration of intubation procedure [ Time Frame: 1. postoperative day ]
  • pain [ Time Frame: 1. postoperative day ]
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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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Procedure: awake intubation
two anesthesia techniques
  • Active Comparator: translaryngeal injection
    translaryngeal injection of local anesthetics before the awake intubation
    Intervention: Procedure: awake intubation
  • Active Comparator: spray as you go
    local anesthetics are given through the fiberoptic during awake intubation
    Intervention: Procedure: awake intubation
Malcharek MJ, Bartz M, Rogos B, Günther 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2014
January 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Armin Sablotzki, MD, Klinikum St. Georg gGmbH
Klinikum St. Georg gGmbH
Not Provided
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
Klinikum St. Georg gGmbH
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP