NCT04111237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

June 28, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

June 27, 2018

Last Update Submit

June 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Study Arms (2)

Two Finger

ACTIVE COMPARATOR

two finger method for performing chest compressions

Behavioral: Two Thumb Technique

Two Thumb Technique

EXPERIMENTAL

Two Thumb Technique

Behavioral: Two Finger technique

Interventions

two finger method for chest compression provuision

Two Thumb Technique

Two thumb technique

Two Finger

Eligibility Criteria

Age24 Years - 58 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Neonatology NCHD's from CUMH
  • Participants must have completed Neonatal Resuscitation Programme (NRP)
  • Participants must be working as doctors in the area of neonatology

You may not qualify if:

  • Any history of cardiac or respiratory disorder
  • Physicians who are post-call/sleep deprived
  • Pregannt

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCC

Cork, Ireland

Location

MeSH Terms

Conditions

Cardiac Output, High

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
measuremenst of CO are masked from participants
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2018

First Posted

October 1, 2019

Study Start

June 28, 2018

Primary Completion

July 30, 2018

Study Completion

August 30, 2018

Last Updated

June 24, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations