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

Sponsor
Università degli Studi dell'Insubria (Other)
Overall Status
Completed
CT.gov ID
NCT01669486
Collaborator
(none)
100
1
10
10

Study Details

Study Description

Brief 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 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 or Disease Intervention/Treatment Phase
  • Other: 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.

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
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)
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. The evaluation of pain in critically ill patients [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

Secondary Outcome Measures

  1. The comparisation beetween the CPOT and the BPS scales [Participants will be followed for 3 days]

    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).

  2. The comparisation of CPOT and BPS between medical and surgical critically ill patients [Participants will be followed for 3 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paolo Severgnini, Prof., Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT01669486
Other Study ID Numbers:
  • 1514
First Posted:
Aug 21, 2012
Last Update Posted:
Apr 23, 2013
Last Verified:
Apr 1, 2013
Keywords provided by Paolo Severgnini, Prof., Università degli Studi dell'Insubria
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 23, 2013