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Infant Chest Compression

Primary Purpose

Cardiac Arrest, Infant, Simulation

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Cardiopulmonary resuscitation
Sponsored by
Łukasz Szarpak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiopulmonary resuscitation, chest compression, medical simulation, randomization, quality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • nurses
  • give voluntary consent to participate in the study

Exclusion Criteria:

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

Sites / Locations

  • Faculty of Medicine, Lazarski UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

the two finger chest compression technique

the two thumb chest compression technique

the new two thumb chest compression technique

Arm Description

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

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

'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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 31, 2018
Last Updated
August 3, 2018
Sponsor
Łukasz Szarpak
Collaborators
Wroclaw Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03616938
Brief Title
Infant Chest Compression
Official Title
Impact of Newly Infant Chest Compression Technique on Hemodynamic Effect During CPR: A Multicenter Randomized Crossover Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 28, 2018 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Łukasz Szarpak
Collaborators
Wroclaw Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Infant, Simulation
Keywords
cardiopulmonary resuscitation, chest compression, medical simulation, randomization, quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
study participant had no insight on the simulator or a cardio-monitor display
Allocation
Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the two finger chest compression technique
Arm Type
Experimental
Arm Description
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
Arm Title
the two thumb chest compression technique
Arm Type
Experimental
Arm Description
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
Arm Title
the new two thumb chest compression technique
Arm Type
Experimental
Arm Description
'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
Intervention Type
Procedure
Intervention Name(s)
Cardiopulmonary resuscitation
Intervention Description
2-min cycle of cardiopulmonary resuscitation accorind to the American Heart Association 2015 guidelines
Primary Outcome Measure Information:
Title
systolic blood pressure (SBP)
Description
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 Outcome Measure Information:
Title
diastolic blood pressure (DBP)
Description
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
Title
mean arterial pressure (MAP)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: nurses give voluntary consent to participate in the study Exclusion Criteria: not meet the above criteria wrist or low back diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lukasz Szarpak, PhD
Phone
500186225
Email
lukasz.szarpak@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jacek Smereka, PhD
Phone
601967070
Email
smereka@pop.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak, PhD
Organizational Affiliation
Lazarski University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine, Lazarski University
City
Warsaw
State/Province
Masovian
ZIP/Postal Code
02-662
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
Phone
500186225
Email
lukasz.szarpak@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be available from the principal investigator
Citations:
PubMed Identifier
29896467
Citation
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.
Results Reference
background
PubMed Identifier
29384839
Citation
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.
Results Reference
background
PubMed Identifier
28040386
Citation
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.
Results Reference
background

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Infant Chest Compression

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