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NCT Number: NCT03988127

Perfusion Index in Pain Assessment

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kasr Alainy Hospital

Giza, 5421, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. The correlation between delta PI and delta BPS

    Time frame: 1 minute before the painful stimulus and 1 minute after.

    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

Secondary outcomes

  1. Systolic blood pressure

    Time frame: 1 minute before the painful stimulus and 1 minute after.

    mmHg

  2. Diastolic blood pressure

    Time frame: 1 minute before the painful stimulus and 1 minute after.

    mmHg

  3. Heart rate

    Time frame: 1 minute before the painful stimulus and 1 minute after.

    beat per minute

  4. Richmond Agitation- Sedation scale

    Time frame: 1 minute before the painful stimulus and 1 minute after.

    • 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

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

    Time frame: 1 minute before the painful stimulus and 1 minute after.

    By generating Receiver Operating Characteristic curve

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 17, 2019
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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