Ignite Creation Date:
2024-05-06 @ 12:25 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03757442
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2018-10-15
Brief Title:
Peripheral Perfusion Index in Acute Surgical Patients
Sponsor:
Hvidovre University Hospital
Organization:
Hvidovre University Hospital
Study Overview
Official Title:
An Observational Study of the Association Between the Perioperatively Measured Peripheral Perfusion Index Postoperative Complications and Mortality in Acute Surgical Patients
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction Perioperative haemodynamic instability is associated with postoperative morbidity and mortality Macrocirculatory parameters such as the conventionally obtained mean arterial blood pressure and cardiac output may be uncoupled from the microcirculation during sepsis and severe blood loss and may not necessarily be optimal resuscitation parameters The peripheral perfusion index PPI is derived from the pulse oximetry signal and reflects perfusion Reduced peripheral perfusion is associated with morbidity in critically ill patients and in patients following acute surgery We hypothesize that patients with low intraoperative PPI demonstrate high frequency of postoperative complications and mortality regardless of blood pressure
Methods and analysis We plan to conduct a prospective observational cohort study in patients undergoing acute non-cardiac surgery November 1st 2017 to October 31st 2018 at two University Hospitals Data will be collected prospectively from patient records including patient demographics comorbidity and intraoperative hemodynamic values with PPI as the primary exposure variable and postoperative complications and mortality within 30 and 90 days as outcome variables We primarily assess association between PPI and outcome in multivariate regression models Secondly the predictive value of PPI for outcome using area under the receiver operating characteristics curve is assessed
Ethics and dissemination Data will be reported according to The Strengthening the Reporting of Observational Studies in Epidemiology STROBE Results will be published in a peer reviewed journal The study is approved by the regional research ethics committee storage and management of data has been approved by the Regional Data Protection Agency and access to medical records is approved by the hospital board of directors at the involved hospitals and departments
Methods and analysis We plan to conduct a prospective observational cohort study in patients undergoing acute non-cardiac surgery November 1st 2017 to October 31st 2018 at two University Hospitals Data will be collected prospectively from patient records including patient demographics comorbidity and intraoperative hemodynamic values with PPI as the primary exposure variable and postoperative complications and mortality within 30 and 90 days as outcome variables We primarily assess association between PPI and outcome in multivariate regression models Secondly the predictive value of PPI for outcome using area under the receiver operating characteristics curve is assessed
Ethics and dissemination Data will be reported according to The Strengthening the Reporting of Observational Studies in Epidemiology STROBE Results will be published in a peer reviewed journal The study is approved by the regional research ethics committee storage and management of data has been approved by the Regional Data Protection Agency and access to medical records is approved by the hospital board of directors at the involved hospitals and departments
Detailed Description:
Background Perioperative haemodynamic instability is associated with postoperative morbidity and mortality Patients undergoing acute major abdominal or hip fracture surgery have high complication rates and account for a major part of overall postoperative mortality in developed countries These patients are often frail with multiple comorbidities making them vulnerable to anaesthesia and surgery Despite the benefit of a multidisciplinary effort to improve perioperative care such patients demonstrate a high risk of complications and death Conventional perioperative haemodynamic monitoring is often based only on heart rate HR and mean blood pressure MAP Although perioperative hypotension is associated with complications in major surgery blood pressure is often an inadequate marker of perioperative organ perfusion consequently leading to little precision in administration of fluid and vasoactive medication Minimally-invasive haemodynamic monitoring of cardiac output CO and goal directed therapy based on stroke volume optimization has been associated with improved outcome in major elective surgery but high quality evidence for the advantage of such monitoring in emergency surgery is sparse
Macrocirculatory parameters such as MAP and CO may be uncoupled from the microcirculation during sepsis and severe blood loss due to sympathetic or medically induced vasoconstriction and as such these parameters are not necessarily optimal for resuscitation
Assuming that blood flow is directed from peripheral tissue to vital organs during progressive stages of circulatory impairment and shock a non-invasive method to detect impaired peripheral perfusion could be a relevant endpoint
The peripheral perfusion index PPI has the advantage that is derived from the photoelectric plethysmographic pulse oximetry signal most likely obtained in all patients for evaluation of arterial oxygen saturation SAT already in the emergency room and continued during and after surgery as in wards and in the ICU The PPI reflects the ratio between the pulsatile and non-pulsatile component of the arterial waveform as assessed by light traversing the tissue addressed most often the finger and it decreases in response to hypoperfusionThus PPI reflects changes in peripheral perfusion and blood volume and reduced peripheral perfusion is associated with morbidity following acute surgery in critically ill patients and patients presenting septic shock However it remains uncertain which threshold for PPI should trigger intervention in patients undergoing acute surgery reflecting that evaluation is made only in relatively small populations of mixed medical and surgical patients
Hypothesis We hypothesize that PPI reflects impaired peripheral circulation and that patients with low intraoperative PPI independent of MAP have higher risk of postoperative complications and mortality than patients with normal or high PPI
Objectives The main objective of this study is to evaluate the association between intraoperative PPI and outcome defined as severe postoperative complications and 30- and 90-days mortality Secondly we assess the predictive value of intraoperative PPI in relation to outcome and evaluate whether PPI has better prediction of adverse outcome than the commonly used MAP thresholds and try to establish intervention thresholds for PPI that in acute non-cardiac surgical patients
Macrocirculatory parameters such as MAP and CO may be uncoupled from the microcirculation during sepsis and severe blood loss due to sympathetic or medically induced vasoconstriction and as such these parameters are not necessarily optimal for resuscitation
Assuming that blood flow is directed from peripheral tissue to vital organs during progressive stages of circulatory impairment and shock a non-invasive method to detect impaired peripheral perfusion could be a relevant endpoint
The peripheral perfusion index PPI has the advantage that is derived from the photoelectric plethysmographic pulse oximetry signal most likely obtained in all patients for evaluation of arterial oxygen saturation SAT already in the emergency room and continued during and after surgery as in wards and in the ICU The PPI reflects the ratio between the pulsatile and non-pulsatile component of the arterial waveform as assessed by light traversing the tissue addressed most often the finger and it decreases in response to hypoperfusionThus PPI reflects changes in peripheral perfusion and blood volume and reduced peripheral perfusion is associated with morbidity following acute surgery in critically ill patients and patients presenting septic shock However it remains uncertain which threshold for PPI should trigger intervention in patients undergoing acute surgery reflecting that evaluation is made only in relatively small populations of mixed medical and surgical patients
Hypothesis We hypothesize that PPI reflects impaired peripheral circulation and that patients with low intraoperative PPI independent of MAP have higher risk of postoperative complications and mortality than patients with normal or high PPI
Objectives The main objective of this study is to evaluate the association between intraoperative PPI and outcome defined as severe postoperative complications and 30- and 90-days mortality Secondly we assess the predictive value of intraoperative PPI in relation to outcome and evaluate whether PPI has better prediction of adverse outcome than the commonly used MAP thresholds and try to establish intervention thresholds for PPI that in acute non-cardiac surgical patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None