Validation of the Critical-Care Pain Observation Tool (CPOT) in the Greek Population

• ClinicalTrials.gov Identifier: NCT03654443
• Recruitment Status: Suspended
• First Posted: August 31, 2018
• Last Update Posted: March 31, 2020
• Sponsor: Saint Savvas Anticancer Hospital
• Information provided by (Responsible Party): Georgia Micha, Saint Savvas Anticancer Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain; Intensive Care Units	Diagnostic Test: Critical care pain observation tool	Not Applicable

Detailed Description:

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 study is designed as a prospective randomized crossover clinical trial. Patients will be randomly allocated into two study groups. In Group I the CPOT tool is administered prior to a painful stimulus (ITime0), during the painful stimulus (ITime1) and soon afterwards (ITime2).In Group II the CPOT tool is administered prior to a non painful stimulus(IITime0), during a non-painful stimulus (IITime1) and soon afterwards (IITime2). After these trials the patients in the two groups will crossover into the other group and the whole process will be repeated. The painful stimulus is set to be the passive turning of the patient into the bed and the non painful stimulus is the cleaning of the arm or leg. 20 minutes afterwards the CPOT tool is administered once again in both groups in order to obtain the values when there is no stimulus (ITime3). The tool is administered by two trained members of the study team in a blind manner. Both of the observers administer the tool at the same time but one of them is positioned in the ward of the patient and the other one behind a curtain with no contact with the observer but only with the patient and the monitor.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Only the two observers are aware of the study group and none of the rest of the study team
• Primary Purpose: Other
• Official Title: Greek Validation of the Critical-Care Pain Observation Tool (CPOT) in the Intensive Care Unit Setting
• Actual Study Start Date: July 1, 2018
• Estimated Primary Completion Date: October 1, 2020
• Estimated Study Completion Date: January 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group Painful stimulus; 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; The CPOT tool is administered in a crossover manner by two study observers
Experimental: Group Non-painful stimulus; 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; The CPOT tool is administered in a crossover manner by two study observers

Outcome Measures

Primary Outcome Measures :

1. Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients [ Time Frame: 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 ]
   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.
2. Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients [ Time Frame: 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 ]
   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.
3. Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients [ Time Frame: 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 ]
   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.
4. Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients [ Time Frame: 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 ]
   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.
5. Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients [ Time Frame: 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 ]
   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.
6. Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients [ Time Frame: 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 ]
   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.
7. Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients [ Time Frame: 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 ]
   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.

Secondary Outcome Measures :

1. Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool) values [ Time Frame: 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 ]
   Physiological parameters as mean arterial blood pressure (MAP in mmHg) will be recorded in all patients. In order to calculate the mean arterial pressure, systolic and diastolic pressures will be recorded in the time periods of the assessment.
2. Correlation of numeric pain rating scale (NPRS) to CPOT tool (Critical Care Pain Observation Tool)values [ Time Frame: 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 ]
   NPRS scale (0 equals no pain and 10 equals maximum pain possible)will be performed in all patients that are able to communicate in order to correlate the results with those of the CPOT tool
3. Correlation of physiological parameters to CPOT tool(Critical Care Pain Observation Tool) values [ Time Frame: 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 ]
   Physiological parameters as heart rate will be recorded in all patients.
4. Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool)values [ Time Frame: 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 ]
   Physiological parameters as respiratory rate will be recorded in all patients

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

Greece

Saint Savvas Anticancer Hospital of Athens

Athens, Greece

Sponsors and Collaborators

Saint Savvas Anticancer Hospital

Investigators

• Principal Investigator: Georgia Micha, MD, MSc, PhD; Saint Savvas Anticancer Hospital of Athens

More Information

Publications:

Gélinas 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. Review.

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.

• Responsible Party: Georgia Micha, Principal Investigator, Anaesthesiologist, MD, MSc, PhD, Saint Savvas Anticancer Hospital
• ClinicalTrials.gov Identifier: NCT03654443
• Other Study ID Numbers: StSavvasAH
• First Posted: August 31, 2018
• Last Update Posted: March 31, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pain; Neurologic Manifestations