Comparison by Neuromonitoring of Two Techniques of Trache... | NCT02382887

Studies
Comparison by Neuromonitoring of Two Techniques of Tracheal Intubation in Patients With Unstable Cervical Spine

NCT02382887

Sponsor

University of Lausanne Hospitals

Status

Completed

Last Update Posted

Jan 2, 2018Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Spinal Injuries

Interventions

tracheal intubation
Airtraq
fiberscope

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009Actual

Primary Completion Date

Aug 1, 2017Actual

Completion Date

Aug 1, 2017Actual

First Submitted Date

Mar 3, 2015

First Submission Date that Met QC Criteria

Mar 6, 2015

First Posted Date

Mar 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2017

Last Update Posted Date

Jan 2, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patrick Schoettker,MD PD, MD, PD, University of Lausanne HospitalsPrincipal Investigator

Lead Sponsor

University of Lausanne HospitalsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery.

Commonly, the management of the tracheal intubation is performed by a fiberoptic technique.

However, changes in equipment availability and quality may challenge the fiberoptic intubation technique.

The investigators wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique.

Detailed Description

Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery.

Commonly, the management of the tracheal intubation is performed by a fiberoptic technique (historic gold standard technique).

However, changes in equipment availability and quality may challenge the fiberoptic intubation technique.

We wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique.

Primary outcomes will be the changes in neurophysiologic responses monitored by a neurophysiologist in 5 specific phases:

Basal potential (BM): neuromonitoring while the patient is anesthetized, no movements
Ventilation potential (VM): neuromonitoring while the patient is anesthetized and a bag-mask ventilation is performed
Intubation potential (IP): neuromonitoring while the patient is being intubated with one of the two randomized devices
Post Intubation (PI): neuromonitoring after the patient has been intubated
Post Positioning (PP): neuromonitoring after the patient has been properly positioned on the operating table and is ready for surgery

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tracheal intubation with Fiberscopy	Active Comparator	tracheal intubation with a fiberscope	Procedure: tracheal intubation Device: fiberscope
Tracheal intubation with Airtraq	Experimental	tracheal intubation with an Airtraq	Procedure: tracheal intubation Device: Airtraq

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tracheal intubation	Procedure	tracheal intubation with the Airtraq	Tracheal intubation with Airtraq Tracheal intubation with Fiberscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neuromonitoring modifications (modifications appearing on the neuromonitoring)	modifications appearing on the neuromonitoring during the 5 different phases	30 seconds

Secondary Outcomes

Measure	Description	Time Frame
time necessary for tracheal intubation		180 seconds
tracheal inlet view (best view during intubation)	best view during intubation	10 seconds

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

unstable cervical spine due to a cervical vertebra fracture
American Society of Anesthesia classification 1-3
BMI < 30 kg/m2
patients necessitating a general anesthesia for surgery

Exclusion Criteria:

patient refusal
ASA >3
mouth opening < 15mm
patients with known history of previous orotracheal tumor surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick Schoettker, MD, PD	Chief Medical Officer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dpt of Anesthesiology, University of Lausanne CHUV		Lausanne	Canton of Vaud	1011	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D013124	Spinal Injuries

Ancestor Terms

ID	Term
D019567	Back Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007442	Intubation, Intratracheal

Ancestor Terms

ID	Term
D058109	Airway Management
D013812	Therapeutics
D007440	Intubation
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided