UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026993 |
|---|---|
| Receipt number | R000030949 |
| Scientific Title | PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) |
| Date of disclosure of the study information | 2017/04/21 |
| Last modified on | 2018/10/26 11:05:25 |
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Basic information
Public title
PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY)
Acronym
PRODIGY
Scientific Title
PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY)
Scientific Title:Acronym
PRODIGY
Region
| Japan | Asia(except Japan) | North America |
| Europe |
Condition
Condition
Patients monitored by capnoGraphY
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to derive and validate a risk assessment tool derived from continuous respiratory monitoring and clinical data that can identify patients at greater risk of respiratory depression (RD) episodes when receiving parenteral opioid therapy on the hospital ward. The developed RD risk assessment tool may be used as a guide in identifying patients at risk of RD who could benefit from capnographic monitoring.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Identify subjects at risk of having respiratory depression [Time Frame: 48 hours]
Derive and validate a risk assessment tool to identify subjects at risk of having RD while undergoing opioid therapy on the hospital ward.
Continuous respiratory monitoring using a Capnostream monitor will be included for collecting data for end tidal carbon dioxide (etCO2) and Oxygen saturation (SpO2).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Device: Capnostream 20p and Capnostream 35
Patients will be monitored for 48 hours maximum with Capnography Capnostream 20p or Capnography Capnostream 35 device.
Interventions/Control_2
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients receiving parenteral opioid therapy (for post-surgical or non-surgical) pain on the hospital ward.
2.Adult age (>=18 year old in US and Europe; >=20 years old in Japan; >=21 years old in Singapore).
3.Patient is able and willing to give informed consent.
Key exclusion criteria
1.Expected length of stay =<24 hours.
2.Patient is receiving intrathecal opioids.
3.Post-surgical patients with American Society of Anesthesiologists physical status (ASA PS) V or higher.
4.Patients with the status of Do Not Resuscitate (DNR), hospice, or receiving end of life therapy.
5.Ventilated or intubated patients.
6.Patient is unwilling or unable to comply fully with study procedures (including non-toleration of the capnography cannula) due to any disease condition which can raise doubt about compliance and influencing the study outcome.
7.Patient is a member of a vulnerable population, includinglegal incapacity or evidence that a subject cannot understand the purpose and risks of the study, regardless of authorized representative support.
8.Patient is participating in another potentially confounding drug or device clinical study.
Target sample size
1650
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | UESONO Syoichi |
Organization
Jikei University, School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
shoichiuezono@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TSUCHIYA Ayumi |
Organization
Covidien Japan Inc.
Division name
Medical Science Medical Affairs
Zip code
Address
Shinagawa Season Terrace 1-2-70 Konan, Minato-ku,Tokyo
TEL
03-6776-0295
Homepage URL
Ayumi.tsuchiya@medtronic.com
Sponsor or person
Institute
Covidien Japan Inc.
Institute
Department
Personal name
Funding Source
Organization
Medtronic-MITG
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT02811302
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京慈恵会医科大学附属病院(東京都)
岡山大学病院(岡山県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 21 | 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
| 2017 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 06 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 04 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 05 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 14 | Day |
Last modified on
| 2018 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030949
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