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OpenTrials
Completed

NCT Number: NCT00948350

Anesthesia for Awake Fiberoptic Intubation

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.

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Key information

Conditions

Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum St. Georg gGmbH

Leipzig, Saxony, 04129, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

awake intubation

Procedure

two anesthesia techniques

Primary outcomes

  1. 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

Secondary outcomes

  1. pain after anesthesia

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

Sponsors and collaborators

Lead sponsor

Klinikum St. Georg gGmbH

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jul 29, 2009
Registry last updated
Apr 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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