Comparison of Two Different Resuscitation Devices

NCT ID: NCT03587987

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-03

Study Completion Date

2018-08-30

Brief Summary

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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

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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.

Conditions

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Manual Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Neopuff

neopuff

Group Type ACTIVE_COMPARATOR

Neopff

Intervention Type DEVICE

manual ventilation

r PAP

rPap device

Group Type EXPERIMENTAL

rPap

Intervention Type DEVICE

Manual ventilation

Interventions

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Neopff

manual ventilation

Intervention Type DEVICE

rPap

Manual ventilation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University College Cork

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gene Dempsey

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCC

Cork, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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ECM 4 (x) 05/06/18

Identifier Type: -

Identifier Source: org_study_id

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