opoid induced RD respiratory depression
Conditions
Interventions
NVT
Capnography
respiratory depression
Sponsors
Medtronic B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion 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; OR 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint used to derive the score will be the occurrence of RD episodes resulting by C20p device memory data combined with clinical data and validated by an independent Clinical Endpoint Committee (CEC) during the study course. A RD episode is defined by whichever event is reached first during the monitoring phase: * RR * 8 breaths for * 3 minutes. Or * SpO2 * 85% for * 3 minutes. Or * EtCO2 * 60 mmHg for * 3 minutes. Or * Apnea episode lasting > 30 seconds Or * Any invasive intervention taken from clinical staff to prevent a potential or to treat a respiratory Opioid-Related Adverse Events (ORADE). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 RD risk patients versus no-risk patients will be compared in terms of: * Incidence of both invasive and non-invasive staff interventions (e.g. physical stimulation of the patient, naloxone administration, positive pressure ventilation and assistance from a respiratory therapist or a physician, etc.). * Hospital length of stay, 30 days readmission rate and primary diagnosis upon readmission. * Patient mortality at 30 days. 2 The sub-group of non-surgical patients will be described in terms of specific baseline characteristics, RD occurrence, respiratory ORADE occurrence, etc. 3 Staff satisfaction and patients* satisfaction on the use of capnographic monitoring will be assessed by NRS 1-10 at the end of the monitoring period. Appropriateness of alarms will be measured by calculating sensitivity and specificity based on received operator*s reaction. 4 Respiratory ORADE will be correlated with ASA value as reported in the related reports. 5 IPI value*s variations will be correlated with the occurrence of RD and respiratory ORADE. 6 Abnormal readings/waveform patterns in the first 2.5 hours from monitoring start will be correlated with RD and ORADE occurrence. 7 EtCO2 variations will be correlated with the occurrence of sepsis. 8 Cost associated to invasive staff interventions will be estimate retrospectively using standard cost data from different countries. | — |
Countries
France, Germany, Netherlands, Spain, United Kingdom, United States of America
Outcome results
None listed