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出境医 / 临床实验 / Perfusion Index in Pain Assessment

Perfusion Index in Pain Assessment

Study Description
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.


Condition or disease Intervention/treatment
Pain, Postoperative Diagnostic Test: Perfusion index

Detailed 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.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Perfusion Index as a Tool for Pain Assessment in Critically Ill Intubated Patients
Actual Study Start Date : July 20, 2019
Actual Primary Completion Date : September 20, 2019
Actual Study Completion Date : September 20, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 13, 2019
First Posted Date June 17, 2019
Last Update Posted Date December 23, 2019
Actual Study Start Date July 20, 2019
Actual Primary Completion Date September 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 13, 2019)
  • Systolic blood pressure [ Time Frame: 1 minute before the painful stimulus and 1 minute after. ]
    mmHg
  • Diastolic blood pressure [ Time Frame: 1 minute before the painful stimulus and 1 minute after. ]
    mmHg
  • Heart rate [ Time Frame: 1 minute before the painful stimulus and 1 minute after. ]
    beat per minute
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Perfusion Index in Pain Assessment
Official Title Validation of Perfusion Index as a Tool for Pain Assessment in Critically Ill Intubated Patients
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.

Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Sedated intubated surgical ICU patients aged 18 to 60 years old
Condition 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 13, 2019)
32
Original Estimated Enrollment Same as current
Actual Study Completion Date September 20, 2019
Actual Primary Completion Date September 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03988127
Other Study ID Numbers S-8-2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Amr Kamal Zahran, Cairo University
Study Sponsor Cairo University
Collaborators Not Provided
Investigators Not Provided
PRS Account Cairo University
Verification Date December 2019