The Nociception Level (NOL) Index for Pain Assessment in the Adult Intensive Care Unit

NCT05339737 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 411

Last updated 2022-04-21

No results posted yet for this study

Summary

Assessing pain in the adult intensive care unit (ICU) is challenging because many patients are unable to communicate due to mechanical ventilation and sedation. Therefore, it is necessary to have alternative methods to assess pain in this vulnerable patient population. In this project, the use of a multi-parameter technology (i.e., the Nociception Level (NOL) index) will be tested for pain assessment in ICU adults. The NOL index is a value from 0 to 100 obtained by calculating different parameters (e.g., pulse, skin temperature) captured through a small probe placed on the patient's finger. The NOL was initially developed for assessing nociception, pain and analgesia in anesthetized patients undergoing surgery, and its use in the ICU is new. The NOL's use before, during and after standard care procedures known to be painful (e.g., tube or drain removal, suctioning of secretions through the endotracheal tube) and non-painful (e.g., cuff inflation to measure blood pressure, soft touch) in ICU adults. The NOL will be monitored in three groups: a) patients able to communicate so they can self-report their pain (gold standard criterion) and express behaviors, b) patients unable to communicate but express behaviors (reference criterion), and c) patients unable to communicate and to express behaviors. In the first group, patients will be asked to self-report their pain and procedural distress on a 0 to 10 scale. In the first and second group, patients will be assessed for pain using a standardized behavioral scale which will be completed by trained research staff. In the third group, only the NOL will be monitored. Analgesic and sedative medication administered to patients will also be documented from medical charts. The ability of the NOL to detect pain based on self-reports of pain and behavioral scores, and its ability to discriminate between painful and non-painful procedures will be examined. If found to be useful, the NOL could be used as an alternative measure of pain and improve its recognition and treatment in vulnerable ICU patients.

Conditions

  • Pain, Acute
  • Nociceptive Pain
  • Behavior
  • Critical Illness

Interventions

DEVICE

Nociception Level (NOL) Index

The NOL integrates multiple physiologic parameters that are captured through a finger probe with disposable sensor. These parameters include heart rate, heart rate variability, photoplethysmography pulse wave amplitude, skin conductance and temperature, and their time derivatives. All these parameters are analyzed simultaneously to provide the NOL index which can range from 0 to 100. Values \>25 were found to be indicative of nociception and related-pain in the field of anesthesia. The investigators will use the Pain Monitoring Device-200 (PMD-200)TM, which offers the multi-parametric NOL index (0-100) (Medasense Biometrics Ltd., Ramat Gan, Israel), and was approved by Health Canada for clinical use in September 2017.

Sponsors & Collaborators

  • Jewish General Hospital

    collaborator OTHER
  • Maisonneuve-Rosemont Hospital

    collaborator OTHER
  • McGill University

    lead OTHER

Principal Investigators

  • Céline Gélinas, PhD, RN · McGill University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2026-03-31
Completion
2026-03-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05339737 on ClinicalTrials.gov