Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01669486
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : April 23, 2013
Sponsor:
Information provided by (Responsible Party):
Paolo Severgnini, Università degli Studi dell'Insubria

Tracking Information
First Submitted Date June 14, 2012
First Posted Date August 21, 2012
Last Update Posted Date April 23, 2013
Study Start Date June 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 16, 2012)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 16, 2012)
  • The comparisation beetween the CPOT and the BPS scales [ Time Frame: 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).
  • The comparisation of CPOT and BPS between medical and surgical critically ill patients [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Pain in Intensive Care Unit: Different Rating System Comparing
Official Title The Pain in Intensive Care Unit: An Experimental Research to Compare Behavioural Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT)
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult male and female Critically ill patients Mechanically ventilated patients
Condition Critical Illness
Intervention Other: CPOT, BPS
Scoring pain of the patients during nurses activity in ICU, in particular before and after nurses manoeuvers.
Study Groups/Cohorts 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.
Intervention: Other: CPOT, BPS
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. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 16, 2012)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01669486
Other Study ID Numbers 1514
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Paolo Severgnini, Università degli Studi dell'Insubria
Study Sponsor Università degli Studi dell'Insubria
Collaborators Not Provided
Investigators
Study Director: Paolo MD Severgnini, Prof. Universita' degli Studi dell'Insubria, Varese, Italy
PRS Account Università degli Studi dell'Insubria
Verification Date April 2013