NCT00948350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 20, 2015

Status Verified

April 1, 2015

Enrollment Period

5 years

First QC Date

July 27, 2009

Last Update Submit

April 17, 2015

Conditions

Intubation

Keywords

cervical instabilityawake intubationlaryngeal anesthesia

Outcome Measures

Primary Outcomes (1)

  • patients satisfaction with anesthesia

    participants will be followed for the duration of hospital stay, an expected average of 2 weeks

    up to two weeks after hospital admission

Secondary Outcomes (1)

  • pain after anesthesia

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

Study Arms (2)

translaryngeal injection

ACTIVE COMPARATOR

translaryngeal injection of local anesthetics before the awake intubation

Procedure: awake intubation

spray as you go

ACTIVE COMPARATOR

local anesthetics are given through the fiberoptic during awake intubation

Procedure: awake intubation

Interventions

awake intubationPROCEDURE

two anesthesia techniques

spray as you gotranslaryngeal injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with cervical instability undergoing elective decompression of cervical spine

You may not qualify if:

  • patient refused participation
  • contraindications for awake intubation techniques (e.g. nasal bleeding, anatomical disorders)
  • patient under alcohol or drugs
  • emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum St. Georg gGmbH

Leipzig, Saxony, 04129, Germany

Location

Related Publications (1)

  • Malcharek MJ, Bartz M, Rogos B, Gunther 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.

    PMID: 26086284DERIVED

Study Officials

  • Armin R Sablotzki, MD

    Clinics of Anesthesiology, Critical care and Pain Therapy

    STUDY CHAIR

  • Michael Malcharek, MD

    Clinic of Anesthesiology, Dept. Neuroanesthesia and Neuromonitoring

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 29, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 20, 2015

Record last verified: 2015-04

Locations

DE(1)