NCT06270264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 5, 2024

Last Update Submit

February 13, 2024

Conditions

Unconscious StatePressure Ulcer

Keywords

intensive carenociception level indexpain monitoringpressure ulcerpalliative care

Outcome Measures

Primary Outcomes (1)

  • total fentanyl consumption

    total amount of fentanyl used during pressure ulcer care session

    one day

Secondary Outcomes (2)

  • systolic blood pressure

    one day

  • heart rate

    one day

Study Arms (2)

The NOL

EXPERIMENTAL

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.

Device: the Nociception level index monitoring

The Control

NO INTERVENTION

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.

Interventions

the Nociception level index monitoringDEVICE

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.

The NOL

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 34908872BACKGROUND

  • 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.

    PMID: 32354616BACKGROUND

MeSH Terms

Conditions

UnconsciousnessPressure Ulcer

Condition Hierarchy (Ancestors)

Consciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Berna Caliskan, MD

    Anesthesiology and Reanimation Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, prospective and controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 21, 2024

Study Start

August 1, 2023

Primary Completion

December 15, 2023

Study Completion

January 1, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)