Comparison of Two Different Resuscitation Devices
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|ClinicalTrials.gov Identifier: NCT03587987|
Recruitment Status : Not yet recruiting
First Posted : July 16, 2018
Last Update Posted : July 16, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Manual Ventilation||Device: Neopff Device: rPap||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Manikin Study of the Comparison of Two Different Resuscitation Devices (Neopuff and rPAP) During Simulated Resuscitation in the Neonatal Unit|
|Estimated Study Start Date :||July 3, 2018|
|Estimated Primary Completion Date :||July 30, 2018|
|Estimated Study Completion Date :||August 30, 2018|
Active Comparator: Neopuff
Experimental: r PAP
- Percentage difference in expired tidal volumes produced by rPAP versus Neopuff resuscitation devices during simulated resuscitation using neonatal mannequins [ Time Frame: 1 min ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587987
|Contact: Eugene M Dempseyemail@example.com|