Comparison of Two Different Resuscitation Devices

Not Applicable

Completed

• Conditions: Manual Ventilation
• Interventions: Device: Neopff; Device: rPap

• Registration Number: NCT03587987
• Lead Sponsor: University College Cork

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.

Study Timeline

• Study Start: 2018-07-03
• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-16
• Primary Completion: 2018-07-30
• Study Completion: 2018-08-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neopuff	Neopff	neopuff
r PAP	rPap	rPap device

Primary Outcome Measures

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

Trial Locations

Locations (1)

UCC; 🇮🇪 Cork, Ireland