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 |
PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY)
PRODIGY
PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY)
PRODIGY
Japan | Asia(except Japan) | North America |
Europe |
Patients monitored by capnoGraphY
Anesthesiology |
Others
NO
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.
Efficacy
Exploratory
Not applicable
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).
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Device,equipment |
Device: Capnostream 20p and Capnostream 35
Patients will be monitored for 48 hours maximum with Capnography Capnostream 20p or Capnography Capnostream 35 device.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
1650
1st name | |
Middle name | |
Last name | UESONO Syoichi |
Jikei University, School of Medicine
Department of Anesthesiology
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
03-3433-1111
shoichiuezono@gmail.com
1st name | |
Middle name | |
Last name | TSUCHIYA Ayumi |
Covidien Japan Inc.
Medical Science Medical Affairs
Shinagawa Season Terrace 1-2-70 Konan, Minato-ku,Tokyo
03-6776-0295
Ayumi.tsuchiya@medtronic.com
Covidien Japan Inc.
Medtronic-MITG
Profit organization
USA
YES
NCT02811302
ClinicalTrials.gov
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)
2017 | Year | 04 | Month | 21 | Day |
Unpublished
Completed
2017 | Year | 02 | Month | 16 | Day |
2017 | Year | 04 | Month | 24 | Day |
2018 | Year | 05 | Month | 06 | Day |
2018 | Year | 06 | Month | 04 | Day |
2018 | Year | 06 | Month | 05 | Day |
2018 | Year | 10 | Month | 30 | Day |
2017 | Year | 04 | Month | 14 | Day |
2018 | Year | 10 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030949