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

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 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


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

Value
https://center6.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