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Rescuer Fatigue Using Two Thumb Versus Two Finger Method During Simulated Neonatal Cardiopulomnary Resuscitation

Primary Purpose

Cardiac Output, High

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Two Finger technique
Two Thumb Technique
Sponsored by
University College Cork
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Output, High

Eligibility Criteria

24 Years - 58 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Neonatology NCHD's from CUMH

Participants must have completed Neonatal Resuscitation Programme (NRP)

Participants must be working as doctors in the area of neonatology

Exclusion Criteria:

Any history of cardiac or respiratory disorder

Physicians who are post-call/sleep deprived

Pregannt

Sites / Locations

  • UCC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Two Finger

Two Thumb Technique

Arm Description

two finger method for performing chest compressions

Two Thumb Technique

Outcomes

Primary Outcome Measures

Percentage change in cardiac output after 5 minutes of simulated neonatal CPR
using two different chest compression methods (2-finger method vs. 2-thumb method) on term and preterm mannequins.

Secondary Outcome Measures

Full Information

First Posted
June 27, 2018
Last Updated
June 23, 2020
Sponsor
University College Cork
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1. Study Identification

Unique Protocol Identification Number
NCT04111237
Brief Title
Rescuer Fatigue Using Two Thumb Versus Two Finger Method During Simulated Neonatal Cardiopulomnary Resuscitation
Official Title
Rescuer Fatigue Using Two Thumb Versus Two Finger Method During Simulated Neonatal Cardiopulomnary Resuscitation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Cork

4. Oversight

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

5. Study Description

Brief Summary
The majority of newborns transition successfully from intrauterine to extrauterine life without any assistance. Less than 1% of all newborns will require extensive neonatal resuscitation involving chest compressions (CC) and medications at birth 1. Chest compressions are indicated for those newborns whose heart rate remains less than 60 beats per minute despite adequate ventilation 1. The American Heart Association (AHA) identifies two different methods of delivering chest compressions; a) the two-thumb (TT) method and b) the two-finger (TF) method. The two-thumb method is favoured by the AHA as it results in higher blood pressure and coronary perfusion pressures and can also be delivered from the head of the bed during umbilical catheter insertion 1. The quality of CC plays a vital role in delivering effective cardiopulmonary resuscitation (CPR). Solevag et al. report that high-quality CC requires (A) optimal compression:ventilation (C:V) ratio, (B) adequate CC rate, (C) depth of CC as well as (D) full recoil between compressions 2. The American Heart Association (AHA) recommend delivering chest compressions on the lower third of the sternum to a depth of one third the anterior-posterior (AP) chest diameter. The recommended C:V ratio is 3:1 (90 compressions and 30 breaths per minute) 1. A number of studies have highlighted the effects of rescuer fatigue on quality of chest compressions. One study reported adverse effects on CC quality when performed without interruption over a 3 minute period 6. It has therefore been recommended to rotate rescuers every 2-3 minutes in order to avoid rescuer fatigue and to ensure high quality CC6-7. As well as duration of CC, other factors can contribute to greater levels of rescuer fatigue. A number of studies have looked at the effect of different CC to ventilation methods on rescuer fatigue. Bodingh et al investigated this during simulated infant CPR. They reported greater levels of rescuer fatigue during simulated CPR in CCaV (continuous CC with asynchronous ventilation) at 120 CC per min compared to the recommended 3:1 C:V CPR 3. A similar study was performed by Li et al where rescuer fatigue was assessed during (i) 3:1 C:V ratio, (ii) CCaV at 90 CC per min and (iii) CCaV at 120 CC per min. However, unlike Bodingh et al, they found both 3:1 C:V and CCaV CPR to be equally fatiguing 4. Different CC techniques (TT vs TF method) can also cause varying levels of rescuer fatigue. In a recent study, Jiang et al compared the TT and TF chest compression techniques on infant mannequins and found that the TF method caused greater levels of rescuer fatigue compared with the TT method 5. We therefore set out to investigate whether different CC techniques cause different levels of rescuer fatigue during neonatal CPR. We hypothesize that performing TF method on neonatal mannequins will produce greater levels of rescuer fatigue. The results of this study would have significant implications in terms of choice of CC technique in new-born resuscitation. The purpose of this study is to compare rescuer fatigue during simulated neonatal chest compressions using two different CC methods; the two-finger (TF) method vs two-thumb (TT) method. This will be performed on both preterm and term mannequins by neonatologists and level of fatigue will be assessed by measuring change in cardiac output during chest compressions. Hypothesis: Performing CC using the two-finger (TF) method produces higher levels of rescuer fatigue compared with the two-thumb (TT) method during 5 minutes of simulated neonatal CPR.
Detailed Description
Inclusion criteria Neonatology NCHD's from CUMH Participants must have completed Neonatal Resuscitation Programme (NRP) Participants must be working as doctors in the area of neonatology Exclusion criteria 1. Any history of cardiac or respiratory disorder 2. Physicians who are post-call/sleep deprived Intervention: This will be a crossover trial. Each participant will be assigned to performing ether TT or TF chest compressions. The participant will each perform 5 minutes of simulated chest compressions either a term or preterm mannequin using 3:1 C:V CPR. Each participant will have NICOM leads attached to their body which will record HR and cardiac output. One week later the participant will cross over and perform the alternate CC technique. The trial will initially be performed on a term mannequin for the first 2 weeks before being repeated on a preterm mannequin. Data Collection: Recorded data will include: Age, gender, ethnicity, weight, height, BMI, HR and cardiac output. Participants will have an allocated study number, ensuring that the data collected will be anonymised. The list of study numbers and data will be stored in a secure password protected database in the Neonatal Unit. Only people involved in the study and other authorised persons will have access to this information. Outcome Measures: Primary Outcome Measure: Percentage change in cardiac output after 5 minutes of simulated neonatal CPR using two different chest compression methods (2-finger method vs. 2-thumb method) on term and preterm mannequins. Secondary Outcome Measure: Perceived level of fatique. At the end of the study session each subject will complete a Likert scale-based questionnaire on subjective feeling of fatigue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Output, High

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
measuremenst of CO are masked from participants
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Two Finger
Arm Type
Active Comparator
Arm Description
two finger method for performing chest compressions
Arm Title
Two Thumb Technique
Arm Type
Experimental
Arm Description
Two Thumb Technique
Intervention Type
Behavioral
Intervention Name(s)
Two Finger technique
Intervention Description
two finger method for chest compression provuision
Intervention Type
Behavioral
Intervention Name(s)
Two Thumb Technique
Intervention Description
Two thumb technique
Primary Outcome Measure Information:
Title
Percentage change in cardiac output after 5 minutes of simulated neonatal CPR
Description
using two different chest compression methods (2-finger method vs. 2-thumb method) on term and preterm mannequins.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Neonatology NCHD's from CUMH Participants must have completed Neonatal Resuscitation Programme (NRP) Participants must be working as doctors in the area of neonatology Exclusion Criteria: Any history of cardiac or respiratory disorder Physicians who are post-call/sleep deprived Pregannt
Facility Information:
Facility Name
UCC
City
Cork
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No

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Rescuer Fatigue Using Two Thumb Versus Two Finger Method During Simulated Neonatal Cardiopulomnary Resuscitation

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