- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02295631
ETI During Spinal Trauma
November 26, 2014 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education
A Comparison of Conventional Tube and ETView VivaSight SL Tube for Tracheal Intubation in Patients With a Cervical Spine Immobilisation. A Randomized Cross-over Manikin Trial.
The aim of this study was to compare time, success rates of different tracheal tubes (standard tube and ETView VivaSight SL) for intubation with an immobilized cervical spine in a standardized manikin model.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Masovia
-
Warsaw, Masovia, Poland, 03-122
- Recruiting
- International Institute of Rescue Research and Education
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- give voluntary consent to participate in the study
- minimum 1 year of work experience in emergency medicine
- experienced emergency medicine personnel (physicians, nurses, paramedics)
Exclusion Criteria:
- not meet the above criteria
- wrist or low back diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ETI during immobilized spine (oral intubation)
intubation with immobilized cervical spine endotracheal intubation with immobilized cervical spine
|
ETI with standard tracheal tube and Macintosh laryngoscope
ETI with ETView VivaSight SL
|
Experimental: ETI during immobilized spine (nasal intubation)
intubation with immobilized cervical spine endotracheal intubation with immobilized cervical spine
|
ETI with standard tracheal tube and Macintosh laryngoscope
ETI with ETView VivaSight SL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success of intubation
Time Frame: 1 day
|
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intubation time
Time Frame: 1 day
|
time in seconds required for a successful intubation attempt
|
1 day
|
Cormack-Lehane grading
Time Frame: 1 day
|
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
|
1 day
|
Preferred ETI device
Time Frame: 1day
|
participants were asked which method of ETI they would prefer in a real-life resuscitation.
|
1day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
November 18, 2014
First Submitted That Met QC Criteria
November 18, 2014
First Posted (Estimate)
November 20, 2014
Study Record Updates
Last Update Posted (Estimate)
December 2, 2014
Last Update Submitted That Met QC Criteria
November 26, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETI/2014/42
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiac Arrest
-
Italian Resuscitation CouncilUnknownOut-Of-Hospital Cardiac Arrest | In-hospital Cardiac ArrestItaly
-
Emergency Medical Services, Capital Region, DenmarkOdense University Hospital; TrygFonden, Denmark; Aalborg University HospitalUnknownOut-Of-Hospital Cardiac Arrest | Pediatric Disorder | Cardiopulmonary ArrestDenmark
-
Medical University of ViennaLudwig Boltzmann Institute Digital Health and Patient Safety; Emergency Medical...RecruitingCardiac Arrest, Out-Of-HospitalAustria
-
University Medical Centre MariborOHK Medical DevicesRecruiting"The Effect of the Use of an Autotransfusion Device on Hemodynamic Parameters During Resuscitation".Cardiac Arrest | Out of Hospital Cardiac ArrestSlovenia
-
National Taiwan University HospitalRecruitingOut-Of-Hospital Cardiac ArrestTaiwan
-
Far Eastern Memorial HospitalRecruitingOut-Of-Hospital Cardiac ArrestTaiwan
-
King's College LondonKing's College Hospital NHS Trust; London Ambulance Service NHS TrustNot yet recruiting
-
Wroclaw Medical UniversityWroclaw Emergency Medical ServicesRecruiting
-
Sunnybrook Health Sciences CentrePrescott-Russell Paramedic Service; Peterborough Paramedic Service; Bruce County... and other collaboratorsRecruiting
-
Emergency Medical Services, Capital Region, DenmarkTrygFonden, Denmark; Danish Heart Foundation; Zoll Medical CorporationRecruitingOut-Of-Hospital Cardiac ArrestDenmark
Clinical Trials on Standard tracheal tube
-
University Hospital, LilleCompletedCritical Illness | Ventilator Associated Pneumonia | Mechanical Ventilation ComplicationFrance
-
International Institute of Rescue Research and...Completed
-
Baylor College of MedicineCompleted
-
Shanghai Ninth People's Hospital Affiliated to...Unknown
-
Taipei Veterans General Hospital, TaiwanCompletedPain, Postoperative | Dysphonia | Intubation, IntratrachealTaiwan
-
Zhuan ZhangRecruiting
-
Ornge Transport MedicineWithdrawnBarotrauma | Injury of Trachea | Friction and Pressure Injuries | Transfer/Transport InjuryCanada
-
University Medical Center GroningenCompleted
-
Hospital Clinic of BarcelonaSociedad Española de Neumología y Cirugía Torácica; Fondo de Investigacion...CompletedMechanical Ventilation | Ventilator-Associated PneumoniaSpain
-
Universitair Ziekenhuis BrusselRecruitingIntubation Complication | Laryngeal Mask ComplicationBelgium