Anesthesia for Awake Fiberoptic Intubation

This study is currently recruiting participants.

Verified November 2012 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: November 12, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 27, 2009

Last Updated Date

November 12, 2012

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

patients satisfaction [ Time Frame: 1. postoperative day, 28. postoperative day ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00948350 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Anesthesia for Awake Fiberoptic Intubation

Official Title ^ICMJE

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

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Intubation

Intervention ^ICMJE

Procedure: awake intubation

two anesthesia techniques

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

January 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00948350

Other Study ID Numbers ^ICMJE

EK-BR-34/08-1, Stu08/0041

Has Data Monitoring Committee

Responsible Party

Armin Sablotzki, MD, Klinikum St. Georg gGmbH

Study Sponsor ^ICMJE

Klinikum St. Georg gGmbH

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Klinikum St. Georg gGmbH

Verification Date

November 2012

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

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