Critical IllnessICPainNCT01669486
The Pain in Intensive Care Unit: Different Rating System Comparing
An observational study of Critical Illness, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
The purpose of this research is to find the best system for assessing the pain of critically ill patient in Intensive Care Unit (ICU). At first the investigators assess the sedation of the patient with the scale sedation-agitation scale (SAS) or the delirium with the confusion assessment method, if the patient is too… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- CPOT, BPS
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2012to Apr 2013
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male and female Critically ill patients Mechanically ventilated patients
Who may be able to join
- male and female
- require of Mechanical Ventilation (MV)
- Hospitalization on ICU > 24 hours
Who cannot join
- Age < 18 years
- Tetraplegic
- Neuromuscolar disease
- Neuromuscolar blocking agents by continuous infusion
- Spontaneous breathing without Mechanical Ventilation (MV)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda ospedaliera ospedale Circolo e Fondazione Macchi
Varese, Varese, 21100
About this study
Official title: The Pain in Intensive Care Unit: An Experimental Research to Compare Behavioural Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT)
The purpose of this research is to find the best system for assessing the pain of critically ill patient in Intensive Care Unit (ICU).
At first the investigators assess the sedation of the patient with the scale sedation-agitation scale (SAS) or the delirium with the confusion assessment method, if the patient is too sedated or delirious the investigators consider him unable to use the Visual Analogic Scale (VAS).
Read more
The investigators compare two different scales Critical Care Pain Observation Tool (CPOT) and Behavioural Pain Scale (BPS) which include no verbal items. Each items has been evaluated in three different moments: before, during and after the nurses' care.
The investigators compare the scales between them. Then, every time the investigators value the score of these scales with the self-report of patients with the VAS scale (when it is possible) and finally with the physiological parameters (blood pressure, heart rate and respiratory rate).
In the end, the investigators compare two different classes of patient: the surgical and medical one. The investigators search for some differences in the perception of the pain between these two classes.
Read the detailed description
This study has specific aims:
- to find the best method to evaluate the pain in critically ill patients;
- to compare the perception of pain analysed trough CPOT and BPS;
- to compare CPOT and BPS between medical and surgical patients.
- Conditions
- Critical Illness
- Being tested
- CPOT, BPS
- Keywords
- Pain, ICU, Mechanical ventilation, CPOT, BPS
- Medical subject headings
- Critical Illness, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPOT, BPSOther
Scoring pain of the patients during nurses activity in ICU, in particular before and after nurses manoeuvers.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | All patients admitted to ICU for a minimal hospitalization of 24 hours, invasive mechanically ventilated, will be evaluated with CPOT and BPS scores, during nurses work, in particular before and after nurses manoeuvers. Receives: Other: CPOT, BPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of pain in critically ill patients
The measurement of pain with no verbal items of different pain scales: facial expression, movements of the body, muscle tone, compliance of mechanical ventilation, movements of the arms. We'll evaluate the level of pain before and after nurses manoeuvers
Measured: Participants will be followed for 3 days
Secondary outcomes (2)
The comparisation beetween the CPOT and the BPS scales
The comparisation beetween the different items of two scales: CPOT (facial expression, movements of the body, muscle tone, compliance of mechanical ventilation) and BPS (facial expression, movements of the arms, compliance of mechanical ventilation).
Measured: Participants will be followed for 3 days
The comparisation of CPOT and BPS between medical and surgical critically ill patients
We'll measure facial expression, movements of the body, muscle tone, compliance of mechanical ventilation, movements of the arms, according with BPS and CPOT scores in two classes of patient: the surgical and medical critically ill patients.
Measured: Participants will be followed for 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Severgnini, Università degli Studi dell'Insubria
- Investigators
- Paolo MD Severgnini, Prof., Study director, Universita' degli Studi dell'Insubria, Varese, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669486
- Sponsor's protocol ID
- 1514
- Acronym
- ICPain
- Status last verified
- Apr 2013
- First submitted
- 14 Jun 2012
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Severgnini P, Pelosi P, Contino E, Serafinelli E, Novario R, Chiaranda M. Accuracy of Critical Care Pain Observation Tool and Behavioral Pain Scale to assess pain in critically ill conscious and unconscious patients: prospective, observational study. J Intensive Care. 2016 Nov 7;4:68. doi: 10.1186/s40560-016-0192-x. eCollection 2016.
PubMed 27833752
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pain in Intensive Care Unit: An Experimental Research to Compare Behavioural Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT)
- ClinicalTrials.gov ID
- NCT01669486
- Acronym / sponsor ID
- ICPain / 1514
- Conditions
- Critical Illness
- Keywords
- Pain, ICU, Mechanical ventilation, CPOT, BPS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Aug 2012 (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.
The purpose of this research is to find the best system for assessing the pain of critically ill patient in Intensive Care Unit (ICU).
At first the investigators assess the sedation of the patient with the scale sedation-agitation scale (SAS) or the delirium with the confusion assessment method, if the patient is too sedated or delirious the investigators consider him unable to use the Visual Analogic Scale (VAS).
The investigators compare two different scales Critical Care Pain Observation Tool (CPOT) and Behavioural Pain Scale (BPS) which include no verbal items. Each items has been evaluated in three different moments: before, during and after the nurses' care.
The investigators compare the scales between them. Then, every time the investigators value the score of these scales with the self-report of patients with the VAS scale (when it is possible) and finally with the physiological parameters (blood pressure, heart rate and respiratory rate).
In the end, the investigators compare two different classes of patient: the surgical and medical one. The investigators search for some differences in the perception of the pain between these two classes.
Detailed description
This study has specific aims:
- to find the best method to evaluate the pain in critically ill patients;
- to compare the perception of pain analysed trough CPOT and BPS;
- to compare CPOT and BPS between medical and surgical patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Other: CPOT, BPSAll patients admitted to ICU for a minimal hospitalization of 24 hours, invasive mechanically ventilated, will be evaluated with CPOT and BPS scores, during nurses work, in particular before and after nurses manoeuvers. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and female Critically ill patients Mechanically ventilated patients
Key inclusion criteria (3 listed)
- male and female
- require of Mechanical Ventilation (MV)
- Hospitalization on ICU > 24 hours
Key exclusion criteria (5 listed)
- Age < 18 years
- Tetraplegic
- Neuromuscolar disease
- Neuromuscolar blocking agents by continuous infusion
- Spontaneous breathing without Mechanical Ventilation (MV)
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, BPSScoring pain of the patients during nurses activity in ICU, in particular before and after nurses manoeuvers. | Other | ICU patients |
Primary outcome
The evaluation of pain in critically ill patients
Time frame: Participants will be followed for 3 days
The measurement of pain with no verbal items of different pain scales: facial expression, movements of the body, muscle tone, compliance of mechanical ventilation, movements of the arms. We'll evaluate the level of pain before and after nurses manoeuvers
2 secondary outcomes
The comparisation beetween the CPOT and the BPS scales
Time frame: Participants will be followed for 3 days
The comparisation of CPOT and BPS between medical and surgical critically ill patients
Time frame: Participants will be followed for 3 days
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 23 Apr 2013.
- Derived from this study: PubMed 27833752Severgnini P, Pelosi P, Contino E, Serafinelli E, Novario R, Chiaranda M. Accuracy of Critical Care Pain Observation Tool and Behavioral Pain Scale to assess pain in critically ill conscious and unconscious patients: prospective, observational study. J Intensive Care. 2016 Nov 7;4:68. doi: 10.1186/s40560-016-0192-x. eCollection 2016.
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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.
Paolo MD Severgnini, Prof. study director
Universita' degli Studi dell'Insubria, Varese, Italy
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 Critical Illness, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 3 inclusion and 5 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 23 Apr 2013. 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 Italy. 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?
The evaluation of pain in critically ill patients (time frame: Participants will be followed for 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01669486, which also lists 1 linked publication.
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 23 Apr 2013.