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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 330

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint used to derive the score will be the occurrence of RD<br /><br>episodes resulting by C20p device memory data combined with clinical data and<br /><br>validated by an independent Clinical Endpoint Committee (CEC) during the study<br /><br>course. A RD episode is defined by whichever event is reached first during the<br /><br>monitoring phase:<br /><br>* RR * 8 breaths for * 3 minutes.<br /><br>Or<br /><br>* SpO2 * 85% for * 3 minutes.<br /><br>Or<br /><br>* EtCO2 * 60 mmHg for * 3 minutes.<br /><br>Or<br /><br>* Apnea episode lasting > 30 seconds<br /><br>Or<br /><br>* Any invasive intervention taken from clinical staff to prevent a potential or<br /><br>to treat a respiratory Opioid-Related Adverse Events (ORADE).</p><br>

Secondary Outcome Measures

Name	Time	Method

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