Nociception Monitoring in Intensive Care

Not Applicable

Completed

• Conditions: Unconscious State; Pressure Ulcer
• Interventions: Device: the Nociception level index monitoring

• Registration Number: NCT06270264
• Lead Sponsor: Haseki Training and Research Hospital

Brief Summary

Precisely, pain in the ICU is a multidimensional problem with a multivariate of reasons. Still, it would be simpler to manage it in unconscious palliative patients with less source of pain, but only if we can detect it practically with the help of nociception monitors. Using five parameters, nociception level index (NOL) monitoring (Medasense) is differentiated from its alternatives. Other than pain detection, this monitoring can titrate analgesic administration. This study investigates the validity of a new nociception monitoring tool, the nociception level index, and its practical impact on providing adequate analgesia in palliative patients in intensive care.

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 Timeline

• Study Start: 2023-08-01
• Primary Completion: 2023-12-15
• Study Completion: 2024-01-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-21
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The NOL	the Nociception level index monitoring	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.

Primary Outcome Measures

Name	Time	Method
total fentanyl consumption	one day	total amount of fentanyl used during pressure ulcer care session

Secondary Outcome Measures

Name	Time	Method
heart rate	one day	heart rate values before, within and after care
systolic blood pressure	one day	systolic blood pressure values before, within and after care

Trial Locations

Locations (1)

Haseki Training and Research Hospital; 🇹🇷 Istanbul, Sultangazi, Turkey