Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05339737 |
| Other study ID # |
MP-05-2022-2988 |
| Secondary ID |
168983 |
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2022 |
| Est. completion date |
March 31, 2026 |
Study information
| Verified date |
April 2022 |
| Source |
McGill University |
| Contact |
Céline Gélinas, PhD, RN |
| Phone |
5143408222 |
| Email |
celine.gelinas[@]mcgill.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Background: Assessing pain in adult intensive care units (ICU) is challenging because
self-report is often non-feasible due to patients' critical care conditions, mechanical
ventilation and/or sedation. The Critical-Care Pain Observation Tool (CPOT) is the reference
standard alternative measure of pain, but patients must be capable of expressing behaviors.
Therefore, these cannot be used in patients who are heavily sedated or unresponsive (e.g., in
coma), and other pain assessment methods must be explored. Vital signs alone (e.g., heart
rate, blood pressure) are not valid for ICU pain assessment with inter-individual variability
being a major limiting factor. The newly developed Nociception Level (NOL) index (Medasense
Biometrics Ltd., Ramat Gan, Israel) is a numeric value from 0 to 100 obtained from
simultaneous different parameters including heart rate, heart rate variability,
photoplethysmography pulse wave amplitude, skin conductance level, number of skin conductance
fluctuations, skin temperature, and their time derivatives. A NOL value>25 would indicate
nociception and related pain in the field of anesthesia. The NOL could adequately classify
nociceptive versus non-nociceptive stimuli with an area under the curve (AUC) >0.90 in
anesthetized patients. The use of the NOL in the ICU is new. The investigators completed
pilot work showing feasibility and promising validity results of the NOL for the detection of
self-reported pain intensity and CPOT scores as reference criteria during chest tube removal
and endotracheal suctioning in medical and surgical ICU patients.
The goal of this study is to validate the NOL index for the assessment of nociception and
related pain in the ICU. Specific objectives are to examine the NOL's ability to:
1. detect pain in patients able to self-report and in non-communicative patients able to
exhibit behavioral responses (i.e., criterion validation);
2. correlate with the patients' self-reports of procedural pain distress during nociceptive
procedures (i.e., convergent validation); and
3. discriminate between non-nociceptive and nociceptive procedures as well as before and
after the administration of a breakthrough dose of an opioid (i.e., discriminative
validation).
As a complementary objective, feasibility and clinical utility of the NOL's use will be
described from the ICU nurses' perspective.
Methods: A prospective cohort observational design will be used in two medical-surgical ICUs
in Montreal where the research team has developed the expertise in the NOL's use. Using
consecutive sampling, the sample will include three patient groups representative of the ICU
population who: a) can communicate (able to self-report) and exhibit behaviors, b) cannot
communicate but can exhibit behaviors, and c) cannot communicate nor exhibit behaviors.
Participants will be observed before, during and 15 minutes after non-nociceptive (i.e., soft
touch, cuff inflation) and nociceptive procedures (e.g., chest tube or drain removal,
endotracheal suctioning, arterial or intravenous catheter insertion, wound care, bed turning)
part of standard care. The NOL will be continuously monitored during all these time points,
patients able to self-report will rate their 0-10 pain intensity and procedural pain
distress, and patients unable to self-report in whom behaviors are observable will be
assessed with the CPOT. Analgesic and sedative agent use will also be documented. Mixed
linear models for repeated measures will be used to compare time points, procedures, and
their interactions. Receiver Operating Characteristic curve analysis of the NOL will be
performed using self-reported pain intensity and CPOT scores as reference criteria. A
convenience sample of ICU nurses will also be recruited to offer them the opportunity to
learn more about the NOL device, to be exposed to its application at the bedside, and to
evaluate its feasibility and potential clinical utility for ICU pain assessment.
The expected outcomes include the validation of a multi-parameter technology in a new context
of care which could be used as an alternative measure to detect nociception and related pain
and to improve pain management and evaluation of analgesia effectiveness in vulnerable ICU
patients.
