Validation of the Polish Version of BPS (POL-BPS).

NCT03127306 | Completed

• 1 other identifier: POL-BPS
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Between 40 to 70% of patients with critical illness experience moderate to severe pain. Diagnosing pain and assessing its severity is difficult in non-verbal patients both in an Intensive Care Unit and in Postoperative Unit after a major surgery such as cardiac surgery). In patients who are unable to self-report pain, we use behavioural pain scales, namely BPS - Behavioural Pain Scale. Aim: The aim of this study was to validate the Polish version of a behavioural pain assessment method - BPS in intubated, sedated patients after cardiac surgery versus self assessment of 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 60 patients. The patients will be observed by two trained observers during a nociceptive procedure (position change), both during analgosedation and analgesia. Patients will be observed 5 minutes before, during, and 15 min after the two sets of interventions (six assessments in total). Each BPS assessment will be carried out by two observers blinded to each other. To validate the Polish BPS translation we will use the following methods: calculations of interrater reliability, criterion validity and discriminant validity.

Conditions

Pain, Acute

Keywords

Pain; Behavioural Pain Scale; BPS; NRS; Delirium; CAM-ICU

Outcome Measures

Primary Outcomes (1)

• Interrater variability for Polish BPS.

  Validation of Polish BPS.

  Through study completion and up to 24 weeks.

Secondary Outcomes (2)

• Criterion validity for Polish BPS.

  Through study completion and up to 24 weeks.

• Discriminant validity for Polish BPS

  Through study completion and up to 24 weeks.

Study Arms (2)

CAM-ICU (+) Delirious patients.

Behavioral: BPS assessment Polish version of BPS tool validation. Other Names: Pain assessment in non-verbal patients

Diagnostic Test: Assessment of Polish version of BPS

CAM-ICU (-) Non-delirious patients.

Behavioral: BPS assessment Polish version of BPS tool validation. Other Names: Pain assessment in non-verbal patients

Diagnostic Test: Assessment of Polish version of BPS

Interventions

Assessment of Polish version of BPS DIAGNOSTIC_TEST

Validation of Polish Version of BPS.

CAM-ICU (+) Delirious patients.; CAM-ICU (-) Non-delirious patients.

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 Postoperative Cardiac Surgery Unit of the tertiary teaching hospital at the Pomeranian Medical University in Szczecin, Poland undergoing minimal analgesia-based sedation protocol (dexmedetomidine + morphine intravenous infusion).

You may qualify if:

• Age above 18 years
• Ability to communicate in the Polish language,
• Intubated and mechanically ventilated patients (controlled modes, spontaneous modes),
• Richmond Agitation Sedation Scale (RASS) above or equal to -3,
• Unrestricted sight and hearing,
• No limitations for body position changing,
• After Cardiac surgery

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

Acute Pain; Pain; Delirium

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

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: Katarzyna Kotfis M.D. Ph.D.

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 25, 2017
• Study Start: June 12, 2017
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

PL (1)