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The Pain in Intensive Care Unit: Different Rating System Comparing (ICPain)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paolo Severgnini, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT01669486
First received: June 14, 2012
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Critical Illness
 Other: CPOT, BPS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pain in Intensive Care Unit: An Experimental Research to Compare Behavioural Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT)

Resource links provided by NLM:

MedlinePlus related topics: Critical Care
U.S. FDA Resources

Further study details as provided by Università degli Studi dell'Insubria:

Primary Outcome Measures:
  • The evaluation of pain in critically ill patients [ Time Frame: Participants will be followed for 3 days ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • The comparisation beetween the CPOT and the BPS scales [ Time Frame: Participants will be followed for 3 days ] [ Designated as safety issue: No ]
    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).

  • The comparisation of CPOT and BPS between medical and surgical critically ill patients [ Time Frame: Participants will be followed for 3 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: June 2012
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
 Other: CPOT, BPS
Scoring pain of the patients during nurses activity in ICU, in particular before and after nurses manoeuvers.
Other Name: CPOT, BPS

Detailed Description:

This study has specific aims:

  1. to find the best method to evaluate the pain in critically ill patients;
  2. to compare the perception of pain analysed trough CPOT and BPS;
  3. to compare CPOT and BPS between medical and surgical patients.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult male and female Critically ill patients Mechanically ventilated patients

Criteria

Inclusion Criteria:

  • male and female
  • require of Mechanical Ventilation (MV)
  • Hospitalization on ICU > 24 hours

Exclusion Criteria:

  • Age < 18 years
  • Tetraplegic
  • Neuromuscolar disease
  • Neuromuscolar blocking agents by continuous infusion
  • Spontaneous breathing without Mechanical Ventilation (MV)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669486

Locations
Italy
Azienda ospedaliera ospedale Circolo e Fondazione Macchi
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
Study Director: Paolo MD Severgnini, Prof. Universita' degli Studi dell'Insubria, Varese, Italy
  More Information

No publications provided

Responsible Party: Paolo Severgnini, Prof., Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT01669486     History of Changes
Other Study ID Numbers: 1514
Study First Received: June 14, 2012
Last Updated: April 22, 2013
Health Authority: Italy: National Institute of Health

Keywords provided by Università degli Studi dell'Insubria:
Pain
ICU
Mechanical ventilation
CPOT
BPS

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013