UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY)
Title of the study (Brief title)	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	UESONO Syoichi
Organization	Jikei University, School of Medicine
Division name	Department of Anesthesiology
Address	3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Email	shoichiuezono@gmail.com

Public contact
Name of contact person	TSUCHIYA Ayumi
Organization	Covidien Japan Inc.
Division name	Medical Science Medical Affairs
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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