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Status unknownNCT03616938Updated Aug 6, 2018

Infant Chest Compression

An interventional study of Cardiopulmonary resuscitation in Cardiac Arrest, Infant and Simulation, sponsored by Łukasz Szarpak. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-06.

Sponsored by Łukasz Szarpak · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

our aim was to quantitatively compare the quality of chest-compression of the new two thumb chest compression (nTTT) versus the current standard techniques: two finger technique (TFT), two thumb technique (TTHT) as defined by systolic-, diastolic-, mean arterial- and pulse-pressures. Our hypothesis is that nTTT generates higher arterial blood pressures compared to the established TFT and TTHT in an infant manikin model.

Read the detailed description

To simulate the scenario of infant CPR, an ALS Baby trainer manikin (Laerdal Medical, Stavanger, Norway) simulating a 3-month-old infant. The manikin was connected with a fixed-volume arterial system attached to a monitor (Draeger Infinity® Delta; Draegerwerk AG \& Co. KGaA, Luebeck, Germany) via an arterial pressure transducer (Edward Lifesciences: TruWave Disposable Pressure Transducer; Irvine, CA, USA). The arterial circuit composed of a 50-mL bag of normal saline solution (air removed) attached to the manikin chest plate and connected to the transducer with a 20-gauge intravenous catheter and tubing. The manikin was placed on a high adjustable hospital stretcher. The bed was leveled to the iliac crest of each rescuer for standardization. The manikin was previously intubated and ventilation was performed using a resuscitator bag.

02

Conditions studied

  • Cardiac Arrest
  • Infant
  • Simulation

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Keywords

  • cardiopulmonary resuscitation
  • chest compression
  • medical simulation
  • randomization
  • quality
03

In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's planned enrollment of 65 is below the median of 100 across 557 interventional studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

This is the only study on the registry with Łukasz Szarpak as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • nurses
  • give voluntary consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • not meet the above criteria
  • wrist or low back diseases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
65 participants (estimated)

Study arms

  • Experimental
    the two finger chest compression technique

    Two finger technique (TFT): the pediatric thorax is compressed with the tips of two fingers and is recommended for lone rescuer during infant cardiopulmonary resuscitation by international resuscitation guidelines

    Procedure: Cardiopulmonary resuscitation

  • Experimental
    the two thumb chest compression 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

    Procedure: Cardiopulmonary resuscitation

  • Experimental
    the new two thumb chest compression technique

    'new two-thumb technique' (nTTT): this technique consists in using two thumbs directed at the angle of 90° to the chest while closing the fingers of both hands in a fist

    Procedure: Cardiopulmonary resuscitation

Interventions

  • ProcedureCardiopulmonary resuscitation

    2-min cycle of cardiopulmonary resuscitation accorind to the American Heart Association 2015 guidelines

06

What researchers measure

Primary outcomes

  1. systolic blood pressure (SBP)

    The manikin was connected with a fixed-volume arterial system attached to a monitor (Draeger Infinity® Delta; Draegerwerk AG \& Co. KGaA, Luebeck, Germany) via an arterial pressure transducer (Edward Lifesciences: TruWave Disposable Pressure Transducer; Irvine, CA, USA). The arterial circuit composed of a 50-mL bag of normal saline solution (air removed) attached to the manikin chest plate and connected to the transducer with a 20-gauge intravenous catheter and tubing.

    Time frame: 1 day

Secondary outcomes

  1. diastolic blood pressure (DBP)

    The manikin was connected with a fixed-volume arterial system attached to a monitor (Draeger Infinity® Delta; Draegerwerk AG \& Co. KGaA, Luebeck, Germany) via an arterial pressure transducer (Edward Lifesciences: TruWave Disposable Pressure Transducer; Irvine, CA, USA). The arterial circuit composed of a 50-mL bag of normal saline solution (air removed) attached to the manikin chest plate and connected to the transducer with a 20-gauge intravenous catheter and tubing.

    Time frame: 1 day

  2. mean arterial pressure (MAP)

    The manikin was connected with a fixed-volume arterial system attached to a monitor (Draeger Infinity® Delta; Draegerwerk AG \& Co. KGaA, Luebeck, Germany) via an arterial pressure transducer (Edward Lifesciences: TruWave Disposable Pressure Transducer; Irvine, CA, USA). The arterial circuit composed of a 50-mL bag of normal saline solution (air removed) attached to the manikin chest plate and connected to the transducer with a 20-gauge intravenous catheter and tubing.

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Faculty of Medicine, Lazarski University
    Warsaw, Masovian 02-662, Poland
    Recruiting
08

References and documents

Publications

  • Smereka J, Szarpak L, Ladny JR, Rodriguez-Nunez A, Ruetzler K. A Novel Method of Newborn Chest Compression: A Randomized Crossover Simulation Study. Front Pediatr. 2018 May 29;6:159. doi: 10.3389/fped.2018.00159. eCollection 2018. PubMed 29896467 ↗
  • Ladny JR, Smereka J, Rodriguez-Nunez A, Leung S, Ruetzler K, Szarpak L. Is there any alternative to standard chest compression techniques in infants? A randomized manikin trial of the new "2-thumb-fist" option. Medicine (Baltimore). 2018 Feb;97(5):e9386. doi: 10.1097/MD.0000000000009386. PubMed 29384839 ↗
  • Smereka J, Szarpak L, Smereka A, Leung S, Ruetzler K. Evaluation of new two-thumb chest compression technique for infant CPR performed by novice physicians. A randomized, crossover, manikin trial. Am J Emerg Med. 2017 Apr;35(4):604-609. doi: 10.1016/j.ajem.2016.12.045. Epub 2016 Dec 19. PubMed 28040386 ↗

Individual participant data

Plan to share: Undecided — Data will be available from the principal investigator

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03616938
Lead sponsor
Łukasz Szarpak
Collaborators
Wroclaw Medical University
Responsible party
Łukasz Szarpak (Associate Professor, Lazarski University) — Sponsor-investigator
First posted
Aug 6, 2018
Start date
Jul 28, 2018
Primary completion
Aug 2018 (estimated)
Completion
Aug 2018 (estimated)
Last update
Aug 6, 2018

Study contacts

Lukasz Szarpak, PhD
Contact
lukasz.szarpak@gmail.com
500186225
Jacek Smereka, PhD
Contact
smereka@pop.pl
601967070
Lukasz Szarpak, PhD
study director · Lazarski University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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