The Pain in Intensive Care Unit: Different Rating System Comparing

NCT01669486 | Completed DMC

• 1 other identifier: 1514
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

Pain; ICU; Mechanical ventilation; CPOT; BPS

Outcome Measures

Primary Outcomes (1)

• 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

  Participants will be followed for 3 days

Secondary Outcomes (2)

• The comparisation beetween the CPOT and the BPS scales

  Participants will be followed for 3 days

• The comparisation of CPOT and BPS between medical and surgical critically ill patients

  Participants will be followed for 3 days

Study Arms (1)

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

Interventions

CPOT, BPS OTHER

Scoring pain of the patients during nurses activity in ICU, in particular before and after nurses manoeuvers.

ICU patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male and female Critically ill patients Mechanically ventilated patients

You may qualify if:

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

You may not qualify if:

• Age \< 18 years
• Tetraplegic
• Neuromuscolar disease
• Neuromuscolar blocking agents by continuous infusion
• Spontaneous breathing without Mechanical Ventilation (MV)

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

Azienda ospedaliera ospedale Circolo e Fondazione Macchi

Varese, Varese, 21100, Italy

Location

Related Publications (1)

• 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.

  PMID: 27833752 DERIVED

MeSH Terms

Conditions

Critical Illness; Pain

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Paolo MD Severgnini, Prof.

  Universita' degli Studi dell'Insubria, Varese, Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: August 21, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

IT (1)