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

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

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

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

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Perfusion Index in Pain Assessment

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