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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03587987
Enrollment
20
Registered
2018-07-16
Start date
2018-07-03
Completion date
2018-08-30
Last updated
2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Manual Ventilation

Brief summary

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.

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.

Interventions

DEVICENeopff

manual ventilation

DEVICErPap

Manual ventilation

Sponsors

University College Cork
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Percentage difference in expired tidal volumes produced by rPAP versus Neopuff resuscitation devices during simulated resuscitation using neonatal mannequins1 minutre

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026