NCT05339737: NOL-ICU

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

Status unknown Last updated 21 April 2022

What this trial tests

trial testing Nociception Level (NOL) Index in Pain, Acute in 411 participants. Status unknown.

Timeline

1 May 2022

Primary endpoint
31 March 2026

31 March 2026

Quick facts

Lead sponsor	McGill University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	411
Start date	1 May 2022
Primary completion	31 March 2026
Estimated completion	31 March 2026

Drugs / interventions tested

• Nociception Level (NOL) Index

Conditions studied

• Pain, Acute — all drugs for Pain, Acute →
• Nociceptive Pain — all drugs for Nociceptive Pain →
• Behavior — all drugs for Behavior →
• Critical Illness — all drugs for Critical Illness →

Sponsor

McGill University

Who can join

18 and older, any sex, with Pain, Acute or Nociceptive Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Validation of the Nociception Level Index for the Detection of Nociception and Pain in Critically Ill Adults: Protocol for an Observational Study.
   Gélinas C, Shahiri T S, Wang HT, Gallani MC, et al · · 2025 · cited 3× · PMID 40053798 · DOI 10.2196/60672
2. Objective monitoring of acute pain and nociception in anaesthesia and intensive care: evidence and applications.
   Danel JK, Rosada-Kurasinska J, Copik MM, Zdanowski S, et al · · 2025 · cited 2× · PMID 41362928 · DOI 10.5114/ait/213842