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

July 27, 2009
July 12, 2013
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00948350 on ClinicalTrials.gov Archive Site
pain after anesthesia [ Time Frame: Change from Baseline in pain after anesthesia at end of hospital stay ] [ Designated as safety issue: No ]
  • duration of intubation procedure [ Time Frame: 1. postoperative day ] [ Designated as safety issue: No ]
  • pain [ Time Frame: 1. postoperative day ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Intubation
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
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
Both
18 Years and older
No
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
Germany
 
NCT00948350
EK-BR-34/08-1, Stu08/0041
No
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
July 2013

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