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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03616938
Other study ID # NLS_2018_UL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 28, 2018
Est. completion date August 2018

Study information

Verified date August 2018
Source Lazarski University
Contact Lukasz Szarpak, PhD
Phone 500186225
Email lukasz.szarpak@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 65
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- nurses

- give voluntary consent to participate in the study

Exclusion Criteria:

- not meet the above criteria

- wrist or low back diseases

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Poland Faculty of Medicine, Lazarski University Warsaw Masovian

Sponsors (2)

Lead Sponsor Collaborator
Lukasz Szarpak Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

References & Publications (3)

Ladny JR, Smereka J, Rodríguez-Núñez 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 day
Secondary 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. 1 day
Secondary 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. 1 day
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