- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03004157
Infant Chest Compression
December 21, 2016 updated by: Łukasz Szarpak, Medical University of Warsaw
A Randomized Comparison of Three Chest Compression Techniques and Associated Hemodynamic Effect During Infant CPR: a Randomized Manikin Study
Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring effective cardiopulmonary resuscitation (CPR).
About 16,000 pediatric cardiac arrests occurs in the United States annually.
Only 8% of the patients survive to hospital discharge and of these, up to two-thirds have neurological sequelae.
Majority of pediatric cardiac arrest are below age of two and have poorer chance of survival versus older children
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
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, 02-005
- Medical University of Warsaw, Department of Emergency Medicine
-
-
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
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- active paramedics
- voluntary consent
Exclusion Criteria:
- pregnancy
- back pain
- wrist pain
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Two finger technique
Two finger technique TFT: the pediatric thorax is compressed with the tips of two fingers and is recommended for lone rescuer during infant CPR by international CPR guidelines
|
CPR for 10 minutes with a chest compression: ventilation ratio of 15:2 according to international CPR guidelines
|
Experimental: Two thumb technique
Two thumb technique TTHT: the two thumbs of the rescuer are placed over the lower third of the sternum, with the fingers encircling the torso and supporting the back.
This technique is recommended for two rescuers during infant CPR by international CPR guidelines
|
CPR for 10 minutes with a chest compression: ventilation ratio of 15:2 according to international CPR guidelines
|
Experimental: new two-thumb technique
new two-thumb technique' (nTTT): this technique consists in using two thumbs directed at the angle of 90 degrees to the chest while closing the fingers of both hands in a fist
|
CPR for 10 minutes with a chest compression: ventilation ratio of 15:2 according to international CPR guidelines
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
systolic blood pressure
Time Frame: 1 day
|
The blood measurement system was calibrated before each CPR setting and blood pressure including systolic blood pressure (SBP)
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
diastolic blood pressure
Time Frame: 1 day
|
The blood measurement system was calibrated before each CPR setting and blood pressure including diastolic blood pressure (DBP)
|
1 day
|
mean arterial pressure
Time Frame: 1 day
|
The blood measurement system was calibrated before each CPR setting and blood pressure including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP)
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
July 1, 2016
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
December 21, 2016
First Submitted That Met QC Criteria
December 21, 2016
First Posted (Estimate)
December 28, 2016
Study Record Updates
Last Update Posted (Estimate)
December 28, 2016
Last Update Submitted That Met QC Criteria
December 21, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Infant11/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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