UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026993
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email Ayumi.tsuchiya@medtronic.com

Sponsor
Institute Covidien Japan Inc.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030949

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.