NCT03004157

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
Last Updated

December 28, 2016

Status Verified

December 1, 2016

Enrollment Period

1 month

First QC Date

December 21, 2016

Last Update Submit

December 21, 2016

Conditions

Keywords

infantcardiopulmonary resuscitationhemodynamicschest compressions

Outcome Measures

Primary Outcomes (1)

  • systolic blood pressure

    The blood measurement system was calibrated before each CPR setting and blood pressure including systolic blood pressure (SBP)

    1 day

Secondary Outcomes (2)

  • diastolic blood pressure

    1 day

  • mean arterial pressure

    1 day

Study Arms (3)

Two finger technique

EXPERIMENTAL

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

Procedure: cardiopulmonary resuscitation

Two thumb technique

EXPERIMENTAL

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

Procedure: cardiopulmonary resuscitation

new two-thumb technique

EXPERIMENTAL

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

Procedure: cardiopulmonary resuscitation

Interventions

CPR for 10 minutes with a chest compression: ventilation ratio of 15:2 according to international CPR guidelines

Two finger techniqueTwo thumb techniquenew two-thumb technique

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • active paramedics
  • voluntary consent

You may not qualify if:

  • pregnancy
  • back pain
  • wrist pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw, Department of Emergency Medicine

Warsaw, Masovia, 02-005, Poland

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Cardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ResuscitationEmergency TreatmentTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, DPH, EMT-P

Study Record Dates

First Submitted

December 21, 2016

First Posted

December 28, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

December 28, 2016

Record last verified: 2016-12

Locations