- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06270264
Nociception Monitoring in Intensive Care
Nociception Level Index Guidance for Analgesia in Pressure Ulcer Care in Unconscious Patients: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study design is randomized, prospective, and controlled in the setting of a level two intensive care unit. 40 patients (n=20) were randomized into control and nociception level. During daily pressure ulcer care, the nociception group received analgesia according to nociception level index monitorization, and the control group had the same protocol as fentanyl bolus doses of 1mcq/kg due to critical care observation pain tool assessment scores. Secondarily, hemodynamic values and variability were evaluated.
Randomization was designed by a computer-based algorithm in a 1:1 ratio into 2 (n= 20) named Group NOL and Group Control and sealed into opaque envelopes. When the inclusion/exclusion criteria are met, at the scheduled time of wound care, the caregiver nurse in the ICU chooses one envelope to apply the designed protocol for each group.
Study Intervention Caregiver nurses in the ICU were educated by the responsible doctor (B.C.) regarding the procedures after selecting study groups. In our ICU unit, routine patient care and simultaneous pressure ulcer interventions are done twice daily as day and night sessions. In our study, the caregiver nurse observed hemodynamic variables and CPOT values for pain evaluation 30 minutes before the day session of care and administered tramadol 1 mg/kg routinely. If CPOT values were still high, then one mcq/kg bolus of fentanyl at each time would be applied and repeated at five-minute intervals, if necessary, during care and 30 minutes after. Hemodynamic variables and CPOT values were noted as before, during, and after care for all patients within two groups, along with stages of pressure ulcers, and all patients had standardized care procedures. Notably, in Group NOL patients, the caregiver nurse assessed pain by NOL monitorization along with CPOT and hemodynamic variables and applied the same analgesia protocol by deciding analgesic need if NOL >25 over one minute at the monitor.
Primary outcome The total amount of analgesia for every patient was noted as the total amount of analgesic drugs used to be stated separately as tramadol and fentanyl within the period starting from 30 minutes before until 30 minutes aftercare. Although the total amount of tramadol used was in standardized protocols as 1 mg /kg, it was also investigated to refrain misevaluation due to overtreatment.
Secondary outcome Heart rate and blood pressure changes before and after care were evaluated within groups, and delta values calculated as the difference between the values at the beginning of ulcer care and before were also noted to question the effect of NOL monitorization on hemodynamic stability.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sultangazi
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Istanbul, Sultangazi, Turkey
- Haseki Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients within the study should be followed up in the adult ICU for palliative needs of care for more than 24 hours, needing respiratory support with tracheostomy or orotracheal intubation and having pressure ulcers (less severe than stage four full-thickness pressure ulcers).
Exclusion Criteria:
- refusal to participate in the study; heart failure, atrial fibrillation and ventricular or atrial tachycardia at a level that impairs hemodynamics; continuous drug infusion for sedation and analgesia; patients with impaired peripheral perfusion and capillary refill exceeding four seconds and patients whose hemodynamics are supported by drugs such as vasopressors and inotropes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The NOL
The caregiver nurse assessed pain by NOL monitorization along with a pain assessment tool (CPOT) and applied one mcg/kg fentanyl if NOL >25 over one minute at the monitor.
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Nociception level index (NOL) monitoring (Medasense) is a non- invasive device differentiated from its alternatives by the use of five parameters: heart rate, heart rate variability, skin conductance level, photo-plethysmography waveform amplitude, number of skin conductance fluctuations, and their time derivatives.
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No Intervention: The Control
If CPOT values were still high, then one mcq/kg bolus of fentanyl at each time would be applied and repeated at five-minute intervals, if necessary, during care and 30 minutes after.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total fentanyl consumption
Time Frame: one day
|
total amount of fentanyl used during pressure ulcer care session
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one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
systolic blood pressure
Time Frame: one day
|
systolic blood pressure values before, within and after care
|
one day
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heart rate
Time Frame: one day
|
heart rate values before, within and after care
|
one day
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Collaborators and Investigators
Investigators
- Principal Investigator: Berna Caliskan, MD, Anesthesiology and Reanimation Department
Publications and helpful links
General Publications
- Gelinas C, Shahiri T S, Richard-Lalonde M, Laporta D, Morin JF, Boitor M, Ferland CE, Bourgault P, Richebe P. Exploration of a Multi-Parameter Technology for Pain Assessment in Postoperative Patients After Cardiac Surgery in the Intensive Care Unit: The Nociception Level Index (NOL)TM. J Pain Res. 2021 Dec 7;14:3723-3731. doi: 10.2147/JPR.S332845. eCollection 2021.
- Shahiri TS, Richard-Lalonde M, Richebe P, Gelinas C. Exploration of the Nociception Level (NOL) Index for Pain Assessment during Endotracheal Suctioning in Mechanically Ventilated Patients in the Intensive Care Unit: An Observational and Feasibility Study. Pain Manag Nurs. 2020 Oct;21(5):428-434. doi: 10.1016/j.pmn.2020.02.067. Epub 2020 Apr 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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