Manual VentilationNCT03587987
Comparison of Two Different Resuscitation Devices
A study testing Neopff and rPap in people with Manual Ventilation, run by University College Cork at 1 site in Ireland.
Trial 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 . Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Manual Ventilation
- What is being tested?
- Neopff and rPap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 3 Jul 2018to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Neonatology consultants and NCHD's from CUMH
- Participants must have completed Neonatal Resuscitation Programme (NRP)
- Participants must be working as doctors in the area of neonatology
Who cannot join
- Any history of cardiac or respiratory disorder
- Physicians who are post-call
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Manual Ventilation
- Being tested
- Neopff, rPap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeopffDevice
manual ventilation
rPapDevice
Manual ventilation
| Study group | Role | What they receive |
|---|---|---|
| Neopuff | Active comparator | neopuff Receives: Device: Neopff |
| r PAP | Experimental | rPap device Receives: Device: rPap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage difference in expired tidal volumes produced by rPAP versus Neopuff resuscitation devices during simulated resuscitation using neonatal mannequins
Measured: 1 minutre
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start3 Jul 2018
- Primary completion30 Jul 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manual VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gene Dempsey, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587987
- Sponsor's protocol ID
- ECM 4 (x) 05/06/18
- Status last verified
- Feb 2023
- First submitted
- 3 Jul 2018
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manikin Study of the Comparison of Two Different Resuscitation Devices (Neopuff and rPAP) During Simulated Resuscitation in the Neonatal Unit
- ClinicalTrials.gov ID
- NCT03587987
- Acronym / sponsor ID
- ECM 4 (x) 05/06/18
- Conditions
- Manual Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 16 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neopuff | Active comparator | Device: Neopffneopuff |
| r PAP | Experimental | Device: rPaprPap device |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Neonatology consultants and NCHD's from CUMH
- Participants must have completed Neonatal Resuscitation Programme (NRP)
- Participants must be working as doctors in the area of neonatology
Key exclusion criteria (2 listed)
- Any history of cardiac or respiratory disorder
- Physicians who are post-call
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neopffmanual ventilation | Device | Neopuff |
| rPapManual ventilation | Device | r PAP |
Primary outcome
Percentage difference in expired tidal volumes produced by rPAP versus Neopuff resuscitation devices during simulated resuscitation using neonatal mannequins
Time frame: 1 minutre
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neopff and rPap in people with Manual Ventilation, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage difference in expired tidal volumes produced by rPAP versus Neopuff resuscitation devices during simulated resuscitation using neonatal mannequins (time frame: 1 minutre). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.