Comparison of Two Different Resuscitation Devices

Manikin Study of the Comparison of Two Different Resuscitation Devices (Neopuff and rPAP) During Simulated Resuscitation in the Neonatal Unit

There is a complex physiological process involved in establishing regular breaths at birth. After initiation of the first breath, fluid is removed from the alveoli and enough pressure must be generated to inflate the lungs . Most newborns will establish spontaneous regular breathing sufficient to maintain the heart rate above 100 beats/min and to improve perfusion within 3 minutes of birth. According to the neonatal resuscitation programme (NRP), if heart rate is below 100 or there is persistence of apnoea or gasping after the initial steps of drying/stimulation and oropharyngeal suction, intervention is required .

The main focus of neonatal resuscitation is effective ventilation to improve gas exchange and prevent respiratory failure. After birth, approximately 4% to 10% of term and late preterm newborns will receive help breathing with positive-pressure ventilation (PPV). Adequate mask ventilation is essential when providing breaths during neonatal resuscitation. However, this can be difficult, especially for less experienced staff and may be affected by inadequate seal of the mask, gas leaks and airway obstruction. In addition, trauma may be caused by the volumes being given during pressure controlled ventilation.

Study Overview

• Status: Completed
• Conditions: Manual Ventilation
• Intervention / Treatment: Device: Neopff; Device: rPap

Detailed Description

Comparison of two different neonatal resuscitation devices (Neopuff and rPAP) in the Neonatal Unit in Cork University Maternity Hospital. Participants will use the devices on a mannequin. Performance of the two devices is judged by comparing the tidal volumes produced.

Participants will be recruited from the medical staff (Non-consultant Hospital Doctors and Consultants) of the neonatal unit.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eugene M Dempsey; Phone Number: 0214920525; Email: gene.dempsey@hse.ie

Study Locations

• Ireland
  • Cork, Ireland
    • UCC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Neonatology consultants and NCHD's from CUMH
2. Participants must have completed Neonatal Resuscitation Programme (NRP)
3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neopuff; neopuff	Device: Neopff; manual ventilation
Experimental: r PAP; rPap device	Device: rPap; Manual ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage difference in expired tidal volumes produced by rPAP versus Neopuff resuscitation devices during simulated resuscitation using neonatal mannequins	1 minutre

Collaborators and Investigators

• Sponsor: University College Cork

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2018
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (Actual): July 16, 2018

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ECM 4 (x) 05/06/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No