Perfusion Index in Pain Assessment

Pain, Postoperative Clinical Trial

Official title:

Validation of Perfusion Index as a Tool for Pain Assessment in Critically Ill Intubated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988127
• Other study ID #: S-8-2019
• Status: Completed
• Start date: July 20, 2019
• Est. completion date: September 20, 2019

Study information

• Verified date: December 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

All patients after admission will be monitored with the use of routine monitoring tools:

Electrocardiogram, pulse oximetry, and automated noninvasive blood pressure (NIBP). Day-to-day investigations will be carried out to monitor and individualize treatment. Medical (and/or) surgical treatment will be performed, supervised by the attending intensivist and surgeon.

Sedation and analgesia protocol will be prescribed by the patient's primary intensivist. Another pulse oximeter probe (Masimo Radical 7; Masimo Corp., Irvine, CA, USA) will be attached to the patient's index finger during changing the patient's position (head of bed elevation) after abdominal surgery. This pulse oximeter will be connected to the Masimo monitor and shielded to prevent outside light from interfering with the signal.

Sedation will be assessed by using the Richmond Agitation- Sedation scale (RASS). Pain assessment will be achieved by using the behavioural pain scale intubated (BPS-IN).

Sedation and analgesia will be guided by the BPS and RASS. For analgesia the patients will receive a loading dose (0.05-0.2 mg/kg) morphine sulphate I.V., followed by (2-10 mg/h) infusion to keep the BPS between 3 and 6. If the pain score is more than 6, a rescue dose of 3 mg will be given, and then the pain will be reassessed after 5 min. If the patient received more than 2 boluses/h, the infusion dose will be increased by 2 mg/h.

For sedation, the patients will receive a loading dose of propofol 0.005 mg/kg/min IV for at least 5 min., followed by (0.005-0.05 mg/kg/min) IV infusion to achieve a RASS score of 0 to -1. A rescue dose of 5-10 mcg/kg/min over 5-10 min intervals if the RASS score is more than 0; allow a minimum of 5 min between adjustments for onset of peak effect.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 20, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Diagnostic Test:
• Perfusion index
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.

Locations

Country	Name	City	State
Egypt	Kasr Alainy Hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Systolic blood pressure	mmHg	1 minute before the painful stimulus and 1 minute after.
Secondary	Diastolic blood pressure	mmHg	1 minute before the painful stimulus and 1 minute after.
Secondary	Heart rate	beat per minute	1 minute before the painful stimulus and 1 minute after.
Secondary	Richmond Agitation- Sedation scale	4: Combative; 3: Very agitated; 2: Agitated; 1: Restless 0: Alert and calm; 1: Drowsy; 2: Light sedation; 3: Moderate sedation; 4: Deep sedation; 5: Unarousable	1 minute before the painful stimulus and 1 minute after.
Secondary	Sensitivity and specificity of PI to predict BPS > or = 6	By generating Receiver Operating Characteristic curve	1 minute before the painful stimulus and 1 minute after.