None listed
Conditions
Brief summary
Hypothesis; "Increasing the frequency with which sedation and agitation is recorded, and continuous monitoring of sedated patients with wearable devices, will provide more useful assessments than standard intermittent scoring, enabling improved correlation of sedation quality with patient outcomes. Measuring blood fentanyl levels will improve our understanding of how these levels change over time and how they correlate with sedation and agitation recordings." The VIGILANT study is an observational study investigating how ICU sedation and agitation patterns relate to patient outcomes. Current tools for assessing sedation are limited by inconsistent frequency which cannot accurately capture sedation dynamics. This study will use the Richmond agitation and sedation scale which has been part of standard of care in Christchurch ICU for many years but it will be registered at an increased and standardized frequency to capture sedation dynamics. This is made possible by the implementing of an updated model of our 24 h chart which allows for more registration points. Additionally, some participants will wear a smart watch to measure their motion and heart rate, and a small subset of participants will have blood samples taken to measure drug levels. The study aims to use this data to improve understanding of sedation dynamics and improve sedation and agitation monitoring, through improved standards and development of objective continuous physiological measurements. Ultimately this study aims to improve sedation management, leading to improved patient outcomes and reduced length of stay.
Interventions
This study is observational. An updated charting model, registered by the bedside nurses, will be implemented in the ICU as part of standard care and will apply to all patients, regardless of study participation. The study will involve the collection of high-resolution agitation and sedation scores to better capture sedation dynamics, made possible by the increased monitoring frequency provided by this updated charting system. Agitation and sedation scores will continue to be recorded using the
This study is observational. An updated charting model, registered by the bedside nurses, will be implemented in the ICU as part of standard care and will apply to all patients, regardless of study participation. The study will involve the collection of high-resolution agitation and sedation scores to better capture sedation dynamics, made possible by the increased monitoring frequency provided by this updated charting system. Agitation and sedation scores will continue to be recorded using the Richmond Agitation-Sedation Scale, which has been used in the Christchurch ICU for many years. Sedation (-5 to 0) will be recorded hourly using the lightest sedation for that hour. Agitation (1 to 4) will be recorded at 15-minute intervals when the patient is agitated. If the patient is not agitated this will be left blank. Data will be collected for the duration of the participants ICU stay using the same chart used for vital signs and drug administration. Data on sedation, agitation, and sedation drugs will be gathered and transferred to an electronic database at discharge. Adherence to this system can be easily assessed by observing patient charts. Roughly 300 participants will be enrolled in the trial. Data collection is expected to take 18 months, finishing in early 2027. Up to 100 participants will have a smartwatch attached to their wrist to measure heart rate and acceleration data. The smartwatch will remain attached for up to 7 days or until the participant no longer requires sedation. If the participant is extubated during the 7-day period, the watch will be left on to measure the participant’s agitation leading up to and following extubation. If the participant is being extubated outside the 7-day period, and there is at least 12 hours lead-time, the smartwatch may be given to them again to record the extubation and subsequent 12 to 24 hours. In both cases, the watch will be removed 12 to 24 hours following extubation, or if the participant has had a RASS score not exceeding 0 for a minimum of 6 hours post extubation. Up to 30 participants will have 6 blood samples taken to measure concentrations of propofol, fentanyl and morphine. These participants will be required to meet the following criteria; • 18 to 80 years of age • Body mass index 18 to 35 mg/m2 • Expected ICU length of stay of three days or more For each patient, three samples will be taken on day of admission at 8, 12, and 24 hour time points. Additional samples are taken at 48 and 72 hour time and finally a sample timed with the decision by the treating team to wean sedation. As soon as a patient is identified as eligible for the main study, they will also be assessed for eligibility for the smartwatch and blood sampling sub studies. If there are no contraindications, consent for all study components will be sought concurrently. Recruitment for the smartwatch and blood sampling sub studies will continue until target enrolment is reached; after that point, only sedation chart data will be collected. The system will be fully implemented for all ICU patients from the 1st of July, and the study will observe patients admitted after this point for an 18-month period.
Sponsors
University of Canterbury
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ICU participants • requiring intravenous sedation with a targeted level within the range of -2 to 1 (as determined by the Richmond Agitation-Sedation Scale (RASS)). • who are anticipated to need sedation for at least 48 hours. For participants eligible for blood sampling the following will also apply; • 18 to 80 years of age • Body mass index 18 to 35 mg/m2 • Expected ICU length of stay of three days or more
Exclusion criteria
• Participants who are not expected to survive for 48 hours are excluded from the study • Participants who are administered neuromuscular blockers • Participants who cannot move their arms will not have a smartwatch attached but may still be included in the trial of the new Agitation scoring system (for smart watch participation) • Patients unsuited for additional blood sampling, for example difficulty with blood access or an increased risk for needing blood transfusion (for blood sampling participation)
Outcome results
None listed