Validation of the Polish Version of CPOT

NCT03024528 | Completed

• 1 other identifier: POL-CPOT
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Pain experienced by critically ill patients is a major problem affecting nearly 50% of the patients. Assessing pain in critically ill patients is a challenge even in an intensive care unit (ICU) with a minimal opioid-based sedation protocol. In patients who are unable to self-report pain, behavioural scales are used, such as CPOT - Critical Care Pain Observation Tool. Aim: The aim of this study was to validate the Polish version of a behavioural pain assessment method - CPOT in an ICU with a minimal sedation protocol (opioid-based) versus self-report pain using Numeric rating scale (NRS) in both delirious and non-delirious patients (assessed using Confusion Assessment Method for ICU, CAM-ICU). Method: A prospective observational cohort study will include 70 patients. The patients will be observed during a non-nociceptive procedure (wash of an arm) and a nociceptive procedure (turning). Patients will be observed 5 minutes before, during, and 15 min after the two interventions (six assessments). Each CPOT assessment will be carried out by two observers blinded to each other. To validate the Polish CPOT translation calculations of interrater reliability, criterion validity and discriminant validity will be performed.

Conditions

Pain; ICU Delirium

Keywords

Pain; CPOT; ICU Delirium; Critical Care Pain Observation Tool; NRS; Behaviour; Critical care; Intensive Care

Outcome Measures

Primary Outcomes (1)

• Interrater variability for Polish CPOT

  Through study completion and up to 24 weeks.

Secondary Outcomes (2)

• Criterion validity for Polish CPOT

  Through study completion and up to 24 weeks.

• Discriminant validity for Polish CPOT

  Through study completion and up to 24 weeks.

Study Arms (2)

CAM-ICU (+)

Delirious patients.

Behavioral: CPOT assessment

CAM-ICU (-)

Non-delirious patients

Behavioral: CPOT assessment

Interventions

CPOT assessment BEHAVIORAL

Polish version of Critical care pain observation tool validation.

Also known as: Pain assessment in non-verbal patients

CAM-ICU (+); CAM-ICU (-)

Eligibility Criteria

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

Study Population

Intubated adult ICU patients at the Intensive Care Unit of the Department of Anaesthesia, Intensive Care and Acute Poisoning of the tertiary teaching hospital at the Pomeranian Medical University in Szczecin, Poland undergoing minimal analgesia-based sedation protocol (fentanyl or morphine intravenous infusion).

You may qualify if:

• Age above 18 years,
• Ability to communicate in the Polish language,
• Richmond Agitation Sedation Scale (RASS) above or equal to -3,
• Unrestricted sight and hearing,
• No limitations for body position changing,

You may not qualify if:

• A medical need for deep sedation - treatment of severe respiratory failure associated with patient-ventilator dyssynchrony, preventing awareness during neuromuscular blockade, status epilepticus, certain surgical conditions requiring immobility , cases of severe brain injury with intracranial hypertension
• Facial trauma (unable to evaluate facial expression),
• Richmond Agitation Sedation Scale (RASS) -4 or -5
• Neurological or psychiatric disorders,
• Use of neuromuscular blocking agents,
• Regular narcotic users,
• Chronic pain syndrome patients.

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Pomeranian Medical University

Szczecin, 70-111, Poland

Location

MeSH Terms

Conditions

Pain; Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Katarzyna L Kotfis, MD,PhD

  Pomeranian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 19, 2017
• Study Start: January 1, 2017
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: April 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)