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 |
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 |
| 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 |
1: Restless 0: Alert and calm
| 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
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| 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. |
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| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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.
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| 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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 |
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| IPD Sharing Statement |
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| 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 | ||||