Infant Chest Compression

Sponsor

Łukasz Szarpak (Other)

Overall Status

Unknown status

CT.gov ID

NCT03616938

Collaborator

Wroclaw Medical University (Other)

Enrollment

Location

Arms

Anticipated Duration (Days)

494.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest Infant Simulation	Procedure: Cardiopulmonary resuscitation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Masking Description:

study participant had no insight on the simulator or a cardio-monitor display

Primary Purpose:

Treatment

Official Title:

Impact of Newly Infant Chest Compression Technique on Hemodynamic Effect During CPR: A Multicenter Randomized Crossover Experimental Study

Actual Study Start Date :

Jul 28, 2018

Anticipated Primary Completion Date :

Aug 1, 2018

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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 2-min cycle of cardiopulmonary resuscitation accorind to the American Heart Association 2015 guidelines
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 2-min cycle of cardiopulmonary resuscitation accorind to the American Heart Association 2015 guidelines
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 2-min cycle of cardiopulmonary resuscitation accorind to the American Heart Association 2015 guidelines

Arm

Intervention/Treatment

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

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

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

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

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

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

Outcome Measures

Primary Outcome Measures

systolic blood pressure (SBP) [1 day]
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.

Secondary Outcome Measures

diastolic blood pressure (DBP) [1 day]
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.
mean arterial pressure (MAP) [1 day]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

nurses
give voluntary consent to participate in the study

Exclusion Criteria:

not meet the above criteria
wrist or low back diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Lazarski University	Warsaw	Masovian	Poland	02-662

Sponsors and Collaborators

Łukasz Szarpak
Wroclaw Medical University

Investigators

Study Director: Lukasz Szarpak, PhD, Lazarski University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Łukasz Szarpak, Associate Professor, Lazarski University

ClinicalTrials.gov Identifier:

NCT03616938

Other Study ID Numbers:

NLS_2018_UL

First Posted:

Aug 6, 2018

Last Update Posted:

Aug 6, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Łukasz Szarpak, Associate Professor, Lazarski University

cardiopulmonary resuscitation

Additional relevant MeSH terms:

Heart Arrest

Study Results

No Results Posted as of Aug 6, 2018