NCT03654443

Brief Summary

The aim of this study is to validate the Critical-Care Pain Observation Tool (CPOT) in the setting of the Intensive care unit (ICU). Prior to patient recruitment the tool will be translated by the method of translation-back translation by Greek and English native speakers. The tool will be administered to patients who are admitted into the ICU.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

June 16, 2018

Last Update Submit

March 28, 2020

Conditions

PainIntensive Care Units

Outcome Measures

Primary Outcomes (7)

  • Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients

    Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of \>2:There is a medium to severe level of pain.

    The CPOT tool (Critical Care Pain Observation Tool) is administered 1 minute prior to a painful stimulus (ITime0) which is set to be the patient's bed repositioning

  • Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients

    Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of \>2:There is a medium to severe level of pain.

    The CPOT tool(Critical Care Pain Observation Tool) is administered 10 seconds after a painful stimulus (ITime1) which is set to be the patient's bed repositioning

  • Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients

    Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of \>2:There is a medium to severe level of pain.

    The CPOT tool(Critical Care Pain Observation Tool) is administered 1 minute after a painful stimulus (ITime2) which is set to be the patient's bed repositioning

  • Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients

    Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of \>2:There is a medium to severe level of pain.

    The CPOT tool (Critical Care Pain Observation Tool)is administered 20 minutes after a painful stimulus (ITime3) which is set to be the patient's bed repositioning

  • Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients

    Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of \>2:There is a medium to severe level of pain.

    The CPOT tool (Critical Care Pain Observation Tool)is administered 1 minute prior to a non painful stimulus (IITime0) which is set to be the patient's blood pressure measurement

  • Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients

    Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of \>2:There is a medium to severe level of pain.

    The CPOT tool(Critical Care Pain Observation Tool) is administered 10 seconds after a non painful stimulus (IITime1) which is set to be the patient's blood pressure measurement

  • Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients

    Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of \>2:There is a medium to severe level of pain.

    The CPOT tool (Critical Care Pain Observation Tool)is administered 1 minute after a painful stimulus (IITime2) which is set to be the patient's blood pressure measurement

Secondary Outcomes (4)

  • Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool) values

    The recordings will be performed 1 minute before, 10 seconds after, 1 minute after and 20 minutes after a painful and a non painful stimulus

  • Correlation of numeric pain rating scale (NPRS) to CPOT tool (Critical Care Pain Observation Tool)values

    The recordings will be performed 1 minute before, 10 seconds after, 1 minute after and 20 minutes after a painful and a non painful stimulus

  • Correlation of physiological parameters to CPOT tool(Critical Care Pain Observation Tool) values

    The recordings will be performed 1 minute before, 10 seconds after, 1 minute after and 20 minutes after a painful and a non painful stimulus

  • Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool)values

    The recordings will be performed 1 minute before, 10 seconds after, 1 minute after and 20 minutes after a painful and a non painful stimulus

Study Arms (2)

Group Painful stimulus

EXPERIMENTAL

The CPOT tool is administered in a crossover manner in Group one prior to a painful stimulus (IT0), during the painful stimulus (IT1) and soon afterwards (IT2)

Diagnostic Test: Critical care pain observation tool

Group Non-painful stimulus

EXPERIMENTAL

The CPOT tool is administered in a crossover manner in Group one prior to a non-painful stimulus (IIT0), during the painful stimulus (IIT1) and soon afterwards (IIT2)

Diagnostic Test: Critical care pain observation tool

Interventions

Critical care pain observation toolDIAGNOSTIC_TEST

The CPOT tool is administered in a crossover manner by two study observers

Group Non-painful stimulusGroup Painful stimulus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted in the ICU
  • Age\> 18 years old
  • No hearing or visual deficit
  • No contraindication to body repositioning

You may not qualify if:

  • Patients with neurological deficit
  • Patients administered with neuromuscular blocking agents
  • Patients with motor or sensory deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Savvas Anticancer Hospital of Athens

Athens, Greece

Location

Related Publications (2)

  • Gelinas C, Fillion L, Puntillo KA. Item selection and content validity of the Critical-Care Pain Observation Tool for non-verbal adults. J Adv Nurs. 2009 Jan;65(1):203-16. doi: 10.1111/j.1365-2648.2008.04847.x. Epub 2008 Nov 15.

    PMID: 19032510BACKGROUND

  • Kanji S, MacPhee H, Singh A, Johanson C, Fairbairn J, Lloyd T, MacLean R, Rosenberg E. Validation of the Critical Care Pain Observation Tool in Critically Ill Patients With Delirium: A Prospective Cohort Study. Crit Care Med. 2016 May;44(5):943-7. doi: 10.1097/CCM.0000000000001522.

    PMID: 26783859BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Georgia Micha, MD, MSc, PhD

    Saint Savvas Anticancer Hospital of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Only the two observers are aware of the study group and none of the rest of the study team
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Anaesthesiologist, MD, MSc, PhD

Study Record Dates

First Submitted

June 16, 2018

First Posted

August 31, 2018

Study Start

July 1, 2018

Primary Completion

October 1, 2020

Study Completion

January 1, 2021

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

GR(1)