Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT02811302
Eligibility Criteria:
Inclusion Criteria:
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.
Exclusion Criteria:
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, including legal 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02811302
Study Brief:
Protocol Section:
NCT02811302