Perfusion Index in Pain Assessment

NCT03988127 | Completed

• 1 other identifier: S-8-2019
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The perfusion index (PI) is the ratio of the pulsatile to the non-pulsatile blood flow in peripheral tissue. It represents a non-invasive measure of peripheral perfusion that can be continuously obtained from a pulse oximeter. This property explains the fact that it decreases with vasoconstriction and increases with vasodilatation. An increase in PI was proved to be an early indicator for the success of general and regional anaesthesia, which cause initial peripheral vasodilatation before the onset of anaesthetic effect. Whereas a failed increase in PI would suggest failure of anaesthesia. The PI has been reported to decrease when noxious stimulus was applied to anaesthetized volunteers. A recent study on critically ill non-intubated patients has demonstrated a good correlation between changes in PI and changes in Behavioral Pain Scale-non intubated values after a painful stimulus was applied. Despite the rising use of perfusion index in anaesthesia and intensive care, few studies have investigated its capability as a pain assessment tool, and to our knowledge, it has not been investigated in intubated critically ill patients yet.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• The correlation between delta PI and delta BPS

  We observe the correlation between the changes in Perfusion index vales and the changes in Behavioral Pain Scale vales before and after the application of painful stimulus

  1 minute before the painful stimulus and 1 minute after.

Secondary Outcomes (5)

• Systolic blood pressure

  1 minute before the painful stimulus and 1 minute after.

• Diastolic blood pressure

  1 minute before the painful stimulus and 1 minute after.

• Heart rate

  1 minute before the painful stimulus and 1 minute after.

• Richmond Agitation- Sedation scale

  1 minute before the painful stimulus and 1 minute after.

• Sensitivity and specificity of PI to predict BPS > or = 6

  1 minute before the painful stimulus and 1 minute after.

Interventions

Perfusion index DIAGNOSTIC_TEST

The perfusion index (PI) is the ratio of the pulsatile to the non-pulsatile blood flow in peripheral tissue. It represents a non-invasive measure of peripheral perfusion that can be continuously obtained from a pulse oximeter. We observe changes in PI before and after painful stimulation in intubated critically ill patients.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Sedated intubated surgical ICU patients aged 18 to 60 years old

You may qualify if:

• Sedated intubated surgical ICU patients during the first two postoperative days following abdominal surgery.

You may not qualify if:

• Patients with a history of neurologic disorder (hemiparesis, quadriparesis, and neuropathy).
• Patients with an epidural catheter with local anaesthetic injection for the purpose of analgesia.
• Patients receiving neuromuscular blockade.
• Patients with peripheral vascular disease.
• Patients suffering from fever.
• Hypothermia.
• Use of vasopressors.
• Patients with altered level of consciousness (GCS \<4).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy Hospital

Giza, 5421, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Perfusion Index

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Design

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

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 17, 2019
• Study Start: July 20, 2019
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Locations

EG (1)