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ID
Source
Brief title
Health condition
Intensive care patients
Mechanical ventilation
Pain in sedated patients
Sponsors and support
Intervention
Outcome measures
Primary outcome
- NOL index values up to 8 hours
Secondary outcome
- Blood pressure and heart rate;
- Drug administration;
- Nociceptive events will be collected on the eCRF;
- Patient age, sex and underlying condition.
Background summary
Several monitors are available that objectively track nociception in sedated or anesthetized patients. One such monitor is used at LUMC, the Nociception level (NOL) monitor (Medasense Biometrics Ltd). In this exploratory, non-interventional trial we will monitor the nociception level index (an index ranging from 0 = absence of nociception to 100 = intense nociception) in sedated and ventilated ICU patients to get an indication of the behavior of the NOL monitor in this specific patient population. The results of this observational trial will be used to power future studies on NOL-guided opioid and sedative administration.
Study objective
This is a hypothesis-free trial but expect similar behavior of the NOL-index in sedated and ventilated ICU patients compared to surgical patients.
Study design
Patients in the ICU of the LUMC will be screened for inclusion. Eligible patients will be connected to the NOL device via two electrodes and a finger cuff placed on dig. V. Although no harm has been observed from use of the finger cuff in patients treated so far at the LUMC, we will move the cuff at 4-6h intervals to another finger to ensure no skin damage due to cuff pressure. This is a preventive measure and not based on existing evidence though. Patients will be connected between 08:00 - 09:00 in the morning and will be disconnected after 8 hours of measuring.
Inclusion criteria
- Aged 18 years or older
- Mechanical ventilation for any reason
- Deemed suitable by the investigators
Exclusion criteria
- Aged 17 years or younger
- Not deemed suitable by the investigators
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9159 |
| Other | WEC Intensive Care/Anesthesiology LUMC : A020-001 |