PainPOL-CPOTNCT03024528
Validation of the Polish Version of CPOT
An observational study of Pain and ICU Delirium, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, ICU Delirium
- What is being tested?
- CPOT assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 71 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2017to 31 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Age above 18 years,
- Ability to communicate in the Polish language,
- Intubated or with tracheostomy for more than 48 hours before inclusion with or without mechanical ventilation (controlled modes, spontaneous modes),
- Richmond Agitation Sedation Scale (RASS) above or equal to -3,
- Unrestricted sight and hearing,
- No limitations for body position changing,
- With no important intervention within last 48 hours prior to inclusion into the study (i.e. operation, tracheostomy).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Polish Version of CPOT (Critical Care Pain Observation Tool) to Assess Pain Intensity in Adult, Intubated ICU Patients, POL-CPOT.
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.
Read the detailed description
Critically ill patients frequently suffer from pain during their stay in the intensive care unit, as nearly 30% of those patients experience pain at rest and up to 50% experience pain during nursing procedures. Pain experienced by critically ill patients falls into four categories that coexist and overlap: pre-existing chronic pain, acute illness-related pain, continuous ICU treatment-related pain or discomfort and intermittent procedural pain. Moreover, acute pain experienced in the ICU may become a chronic problem after discharge from the unit, as a lifelong ICU footprint. Everyday nursing procedures and interventions (i.e. positioning, mouth and trachea suctioning, wound care, catheter removal or placement, cannulation or intubation) performed in the ICU may be a potential source of pain, therefore there is a clinical need for a simple and easy ICU pain scale to evaluate this condition in patients unable to self-report pain.
Assessment of pain in patients treated in the ICU becomes a daily clinical challenge for the ICU team, especially in those units where deep levels of sedation are used, but also in the minimal sedation environment based on analgesia. Various guidelines and recommendations exist to guide the ICU care team in the pain management and assessment process. Nevertheless, the gold standard for pain assessment is patient's self-report of pain (using numeric raing scale - NRS or visual analog scale - VAS), which can be aided with behavioural scales only when the self-report is unreliable or impossible to obtain. Those observational pain scales include the Critical-Care Pain Observation Tool (CPOT) and the Behavioural Pain Scale (BPS) and have been recommended for clinical use in the critically ill adults. However, their validation in a given patient population (cardiac, burn, different languages) is strongly recommended and required.
The need to equip critical care teams with dedicated monitoring tools is clear as early identification warrants early treatment. The CPOT has been developed by ICU professionals, yet it has not been translated or validated in Polish until now.
- Conditions
- Pain, ICU Delirium
- Being tested
- CPOT assessment
- Keywords
- Pain, CPOT, ICU Delirium, Critical Care Pain Observation Tool, NRS, Behaviour, Critical care, Intensive Care
- Medical subject headings
- Pain, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPOT assessmentBehavioural
Also called Pain assessment in non-verbal patients
Polish version of Critical care pain observation tool validation.
| Study group | Role | What they receive |
|---|---|---|
| CAM-ICU (+) | Delirious patients. Receives: Behavioral: CPOT assessment | |
| CAM-ICU (-) | Non-delirious patients Receives: Behavioral: CPOT assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interrater variability for Polish CPOT
Measured: Through study completion and up to 24 weeks.
Secondary outcomes (2)
Criterion validity for Polish CPOT
Measured: Through study completion and up to 24 weeks.
Discriminant validity for Polish CPOT
Measured: Through study completion and up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna Kotfis, Pomeranian Medical University Szczecin
- Investigators
- Katarzyna L Kotfis, MD,PhD, Principal investigator, Pomeranian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024528
- Sponsor's protocol ID
- POL-CPOT
- Acronym
- POL-CPOT
- Status last verified
- Apr 2017
- First submitted
- 12 Jan 2017
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Polish Version of CPOT (Critical Care Pain Observation Tool) to Assess Pain Intensity in Adult, Intubated ICU Patients, POL-CPOT.
- ClinicalTrials.gov ID
- NCT03024528
- Acronym / sponsor ID
- POL-CPOT / POL-CPOT
- Conditions
- Pain, ICU Delirium
- Keywords
- Pain, CPOT, ICU Delirium, Critical Care Pain Observation Tool, NRS, Behaviour, Critical care, Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Critically ill patients frequently suffer from pain during their stay in the intensive care unit, as nearly 30% of those patients experience pain at rest and up to 50% experience pain during nursing procedures. Pain experienced by critically ill patients falls into four categories that coexist and overlap: pre-existing chronic pain, acute illness-related pain, continuous ICU treatment-related pain or discomfort and intermittent procedural pain. Moreover, acute pain experienced in the ICU may become a chronic problem after discharge from the unit, as a lifelong ICU footprint. Everyday nursing procedures and interventions (i.e. positioning, mouth and trachea suctioning, wound care, catheter removal or placement, cannulation or intubation) performed in the ICU may be a potential source of pain, therefore there is a clinical need for a simple and easy ICU pain scale to evaluate this condition in patients unable to self-report pain.
Assessment of pain in patients treated in the ICU becomes a daily clinical challenge for the ICU team, especially in those units where deep levels of sedation are used, but also in the minimal sedation environment based on analgesia. Various guidelines and recommendations exist to guide the ICU care team in the pain management and assessment process. Nevertheless, the gold standard for pain assessment is patient's self-report of pain (using numeric raing scale - NRS or visual analog scale - VAS), which can be aided with behavioural scales only when the self-report is unreliable or impossible to obtain. Those observational pain scales include the Critical-Care Pain Observation Tool (CPOT) and the Behavioural Pain Scale (BPS) and have been recommended for clinical use in the critically ill adults. However, their validation in a given patient population (cardiac, burn, different languages) is strongly recommended and required.
The need to equip critical care teams with dedicated monitoring tools is clear as early identification warrants early treatment. The CPOT has been developed by ICU professionals, yet it has not been translated or validated in Polish until now.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAM-ICU (+) | – | Behavioral: CPOT assessmentDelirious patients. |
| CAM-ICU (-) | – | Behavioral: CPOT assessmentNon-delirious patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- Age above 18 years,
- Ability to communicate in the Polish language,
- Intubated or with tracheostomy for more than 48 hours before inclusion with or without mechanical ventilation (controlled modes, spontaneous modes),
- Richmond Agitation Sedation Scale (RASS) above or equal to -3,
- Unrestricted sight and hearing,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPOT assessmentAlso: Pain assessment in non-verbal patientsPolish version of Critical care pain observation tool validation. | Behavioural | CAM-ICU (+), CAM-ICU (-) |
Primary outcome
Interrater variability for Polish CPOT
Time frame: Through study completion and up to 24 weeks.
2 secondary outcomes
Criterion validity for Polish CPOT
Time frame: Through study completion and up to 24 weeks.
Discriminant validity for Polish CPOT
Time frame: Through study completion and up to 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna L Kotfis, MD,PhD principal investigator
Pomeranian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and ICU Delirium, run by Pomeranian Medical University Szczecin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interrater variability for Polish CPOT (time frame: Through study completion and up to 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.