Nociception Evaluated by the NOL® Index in Sedated Patients in the Intensive Care Unit

NCT05399758 | Suspended DMC

• 1 other identifier: OAIC: 1219/21
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Due to their underlying pathology and the necessary complicated procedures to which they are exposed, patients in the intensive care unit experience varying degrees of pain at some point in their evolution. Evidence has established short-term and long-term negative consequences of unresolved pain or excessive analgesic sedation. However, pain assessment or adequate nociceptive monitoring remains a significant challenge, especially in non-communicative patients under deep sedation, who urgently need to expand and improve current tools. Pain assessment in critically ill patients is challenging; limitations in their ability to communicate (neurocognitive deficit, use of endotracheal tube) or altered consciousness (deep sedation) make them unable to self-report their pain with standard pain scales. The Behavioral Pain Scale (BPS) and the Critical-Care Pain Observation Tool (CPOT) are the pain assessment tools with the best performance and reliability for patients in these conditions. Different technologies are used to monitor nociceptive responses caused by surgical stress in patients under general anesthesia that together with the clinical evaluation, manage to keep patients in the best analgesic conditions, improving the post-surgical prognosis. In particular, the NOL® nociceptive index (Medasense, Ramat Gan, Israel) is a multiparametric detection of nociception/pain, delivering a dimensionless score (0 -100) calculated through an algorithm (patented) and based on the registry of four biometric sensors (photoplethysmography, galvanic skin response, temperature, and accelerometer). NOL index value between 10-25 is the most appropriate for maintaining analgesia during general anesthesia. The ease and low invasiveness of this system (all sensors are implemented in a finger clip, similar to an oxygen saturation monitor) may allow its potential use in the context of intensive care unit patients. Some studies have recently been published that highlight the possible usefulness of the NOL® index in critically ill patients. However, in these studies, the assessment of nociception was limited to acute nociceptive procedures only.

Conditions

Nociceptive Pain; Sedation Complication

Keywords

Nociception; Opioids; Pain monitor

Outcome Measures

Primary Outcomes (1)

• NOL monitor values

  Values will be recorded and compared with fentanyl dosage and clinical pain assesment

  Day 3

Secondary Outcomes (3)

• Fentanyl dosage

  Day 3

• Clinical pain assessment (Behavioral Pain Scale)

  Day 3

• BIS index

  Day 3

Study Arms (1)

ICU sedated patients

Critical patients sedated with propofol and fentanyl The values obtained with the use of the NOL® index will be recorded and compared with the standard measurements of pain assessment (Behavioral Pain Scale (BPS) and/or CPOT)

Device: NOL monitor

Interventions

NOL monitor DEVICE

NOL monitor data will be acquired, as well as clinical assessment of pain and fentanyl dosage.

ICU sedated patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ICU patients sedated with propofol and fentanyl

You may qualify if:

• ICU sedated patients under propofol and fentanyl

You may not qualify if:

• Sedation duration less than 72 h
• Stroke
• Opioid user before ICU hospitalization
• Atrial fibrillation
• Pregnancy/lactation
• Patient with antiarrhythmic agents

Sponsors & Collaborators

• University of Chile: lead

Study Sites (2)

Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile

Santiago, RM, 7690306, Chile

Location

Hospital Clinico de la Universidad de Chile

Santiago, RM, 7690306, Chile

Location

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Anesthesiologist, MD-PhD

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 1, 2022
• Study Start: June 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: July 20, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)