NL-OMON42863
Completed
Not Applicable
PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY - Prodigy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- opoid induced RD
- Sponsor
- Medtronic B.V.
- Enrollment
- 330
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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