UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046867 |
|---|---|
| Receipt number | R000053390 |
| Scientific Title | Effect of visually assisted device of respiratory function monitor on neonatal resuscitation ; Cross-over randomized controlled trial using newborn mannequin |
| Date of disclosure of the study information | 2022/02/08 |
| Last modified on | 2023/03/06 11:16:57 |
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Basic information
Public title
Effect of visually assisted device of respiratory monitor on neonatal resuscitation ; Simulation study using newborn mannequin
Acronym
PPV assist study
Scientific Title
Effect of visually assisted device of respiratory function monitor on neonatal resuscitation ; Cross-over randomized controlled trial using newborn mannequin
Scientific Title:Acronym
PPV assist study
Region
| Japan |
Condition
Condition
newborn who needs resuscitation
Classification by specialty
| Pediatrics | Intensive care medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Approximately 15% of newborns cannot establish spontaneous breathing after birth and need some kind of resuscitation. The current standard of care for assessment of effective positive pressure ventilation in neonatal resuscitation is based on physical findings such as thoracic elevation and vital signs detected by pulse oximeter or heart rate monitoring. In addition, there have been recent reports on the usefulness of respiratory function monitors that can measure ventilation volume and pressure.
With the increase in the number of these monitors, there is a concern that resuscitators may focus only on the monitors instead of the neonates. In this study, we will investigate whether the resuscitator's attention can be focused more on the neonate by attaching a visual feedback device that displays alarms by lighting or flashing lights(PPV assist) to a ventilation device and visually displaying the alarms on the monitor at a position close to the patient.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Gaze ratio (%) defined as a percentage of time spent looking at mannequin and ventilation devices during a given period of time (resuscitation time)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Positive pressure ventilation simulation is performed according to the resuscitation scenario, using a mannequin for neonatal resuscitation practice.
The neonatal respiratory function monitor (NRM-1300) and flow adapter that can measure and display tidal volume and pressure are attached to a ventilation device.
The subject wears an eye tracker, and the viewpoint will be tracked and recorded.
The standard methods for evaluating the effectiveness of positive pressure ventilation in neonatal resuscitation are (1) physical findings such as thoracic elevation, and (2) vital signs detected by pulse oximeter or heart rate monitoring. The subjects will have simulation training in each of the following three evaluation methods: 1) the standard methods described above, 2) 1) with the addition of the respiratory function monitor (NRM-1300), 3) 2) with the addition of the visual feedback device (PPV assist) in three different orders.
Control: The standard methods only
Interventions/Control_2
Interventions(1): The standard methods with the addition of the respiratory function monitor (NRM-1300)
Interventions/Control_3
Interventions(2): The standard methods with the addition of the respiratory function monitor (NRM-1300) and the visual feedback device (PPV assist)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Doctor at National Center for Child Health and Development (Tokyo, Japan)
Key exclusion criteria
-Have not finished neonatal resuscitation training.
-Need visual correction (glasses or contact lenses) for daily life but do not wear contrast lenses, or cannot see within 2 feet (24 cm) with the naked eye (no glasses)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetuya |
| Middle name | |
| Last name | Isayama |
Organization
National Center for Child Health and Development
Division name
Division of Neonatology Center for Maternal-Fetal, Neonatal and Reproductive Medicine
Zip code
157-8535
Address
2-10-1, Okura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
isayama-t@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Ikuta |
Organization
National Center for Child Health and Development
Division name
Division of Neonatology Center for Maternal-Fetal, Neonatal and Reproductive Medicine
Zip code
157-8535
Address
2-10-1, Okura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
Homepage URL
ikuta-y@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
2-10-1, Okura, Setagaya-ku, Tokyo, Japan
Tel
03-3416-0181
rinri@ncchd.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 08 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053390
