PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY - Prodigy

Medtronic B.V.0 个研究点目标入组 330 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•1. Patients admitted to a hospital ward with an ongoing opioid therapy (for both post-surgical and non-surgical pain) by PCA, by epidural or intrathecal infusions or by intravenous analgesia, started in OR, ER, PACU or ICU less than 4 hours before transition to ward;
•Patients starting opioid therapy in the ward for both post-surgical and non-surgical pain therapy, by PCA, by epidural or intrathecal infusions or by intravenous analgesia.
•2. Patients with age *18 year old
•3. Subject is able and willing to give informed consent.

•1. Post-surgical patients with American Society of Anesthesiologists physical status (ASA PS) IV or higher.
•2. Non-surgical patients not suitable for all range of therapies according to their life expectancy.
•3. Ventilated or intubated patients.
•4. Bariatric patients (BMI >50).
•5. Unconsciousness patients that have undergone emergency surgical procedures.
•6. Patients with alcohol or drug abuse history.
•7. Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators.
•8. Subject is unwilling or unable to comply fully with study procedures (including non-toleration of capnography cannula) due to any disease condition (including neurological or psychological impairment) which can raise doubt about compliance and influencing the study outcome.
•9. Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study.
•10. Subject is participating in another potentially confounding drug or device clinical study

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