- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02289872
Pediatric Intubation (ETICPR)
January 21, 2015 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education
Comparison of the TruView PCD Video Laryngoscope and Macintosh Laryngoscope for Pediatric Tracheal Intubation by Novice Paramedics: A Randomized Crossover Simulation Trial.
The aim of the study was to compare time and success rates of TruView PCD video laryngoscope and Macintosh laryngoscope for the pediatric emergency intubation with three airway scenarios in a standardized manikin model.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
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
-
-
Masovie
-
Warsaw, Masovie, Poland, 03-122
- 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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- give voluntary consent to participate in the study
- inexperienced in pediatric intubation paramedics
Exclusion Criteria:
- not meet the above criteria
- participants who had performed intubation in pediatric humans prior the trial or had previously TruView experience
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: Scenario A
The control scenario, where neither chest compression nor cervical stabilization was applied during intubation.
|
Direct-Laryngoscopy
Video-Laryngoscopy
|
Experimental: Scenario B
The chest compression scenario, where continuous chest compression was applied using chest compression system LUCAS-2 (Physio-Control, Redmond, WA, USA).
Chest compression was provided at a rate of 100 min-1 to a depth of 5-6 cm during all intubation procedures.
|
Direct-Laryngoscopy
Video-Laryngoscopy
|
Experimental: Scenario C
The chest compression with cervical stabilization scenario, where both chest compression using Lucas-2 and cervical stabilization were applied.
A correctly fitting standard cervical immobilization collar (StifNeck Select, Laerdal, Stavanger, Norway) was applied to the manikin's neck to prevent movement of the cervical spine.
|
Direct-Laryngoscopy
Video-Laryngoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to intubation
Time Frame: 1 day
|
the time to intubation, defined as the time from insertion of the laryngoscope blade between the teeth to the first manual ventilation of the mannequin's lungs
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cormack-Lehan scale
Time Frame: 1 day
|
self reported Cormack-Lehan scale during intubation
|
1 day
|
Success of intubation
Time Frame: 1 day
|
success of the intubation attempt (i.e.
tracheal or oesophageal placement of the tube) with was recorded when the success of the ventilation attempt was seen by the manikin's ventilation indicators.
|
1 day
|
Dental compression
Time Frame: 1day
|
dental compression, with was assessed using a visual scale grading the pressure applied on the upper teeth (n=none, mild=1, moderate=2, severe=3).
|
1day
|
Ease of intubation (VAS)
Time Frame: 1 day
|
To access subjective opinion about the difficulty of the each intubation method, participants were asked to rate it on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
November 7, 2014
First Submitted That Met QC Criteria
November 12, 2014
First Posted (Estimate)
November 13, 2014
Study Record Updates
Last Update Posted (Estimate)
January 26, 2015
Last Update Submitted That Met QC Criteria
January 21, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TruView/01
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.
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