Peripheral Perfusion Index, Haemoglobin and Blood Transfusion in Acute Surgical Patients

Anastomotic Leak Clinical Trial

Official title:

Association Between the Peripheral Perfusion Index, Haemoglobin Levels and Blood Transfusions in Patients Undergoing Acute Abdominal- and Orthopaedic Surgery.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03795467
• Status: Active, not recruiting
• Start date: November 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: January 2019
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The peripheral perfusion index (PPI) is a non-invasive, feasible measure of peripheral perfusion and, assumed, the overall circulation, which all patients are monitored by.

This study is carried out to assess the association between values of PPI, haemoglobin and blood transfusion.

Hypothetically, patients with low values of hb are more susceptible to a deteriorating circulation reflected in poorer PPI regardless of blood pressure and that resuscitation with blood products improves PPI measurements. Moreover, that patients with low values of PPI have more surgical complications and higher mortality.

Description:

Background: Acute surgical patients with e.g. hip fracture (HF) or acute abdominal surgical conditions often have comorbidities and a fragile circulation. Haemodynamic challenges make these patients vulnerable during anaesthesia, and perioperative complications are frequent.

Anaemia is associated with increased mortality and adverse outcomes in patients undergoing surgery. One of the consequences of acute anaemia is reduced blood oxygen content, leading to reduced tissue oxygen delivery and development of tissue hypoxia. Patients with e.g. HF have a large drop in haemoglobin (hb) level that occurs after the injury, yet prior to the surgery. It is therefore important to be aware of the risk of preoperative anaemia even when the initial hb levels appear to be normal. Perioperative hb are associated with shorter lengths of hospital stay, reduced mortality and lower readmission rates, and patients with postoperative anaemia have increased mortality and length of hospital stay.

Haemodynamic monitoring is traditionally based on measurement of blood pressure (BP) and heart rate (HR) but these measurements may be insufficient in evaluating overall oxygen delivery and perfusion of vital organs. An apparently sufficient BP and, for patients with more specialised monitoring, cardiac output (CO), does not necessarily mean a sufficient peripheral microcirculatory flow due to compensatory mechanisms, but on the other hand a low CO may be sufficient in context of low metabolic demand.

The non-invasive peripheral perfusion index (PPI) is a numerical value of peripheral perfusion measured by the pulse oximeter derived from the photoelectric plethysmographic signal. PPI is represents the ratio between the pulsatile component (arterial) and the non-pulsatile component (venous blood, capillary blood and other tissues) of the light reaching the detector of the pulse oximeter, and reflects changes in peripheral blood flow as the pulsatile component increases with vasodilatation and decreases with vasoconstriction. It is an accessible way to obtain a measure for peripheral perfusion as pulse oximeters are universally available in all operating rooms and intensive care units. Previous studies have shown that PPI is a useful indicator of reduced peripheral blood flow both in clinical and experimental settings. Correlation between clinical symptoms of reduced peripheral perfusion such as low temperature, increased capillary response and reduced PPI in critically ill patients has been demonstrated, and a reduced peripheral perfusion may be a predictor of mortality and complications in patients undergoing major surgical procedures and in septic shock patients.

Hypothetically, patients with low values of hb are more susceptible to a deteriorating circulation reflected in poorer PPI regardless of blood pressure and that resuscitation with blood products improves PPI measurements. Moreover, that patients with low values of PPI have more surgical complications and higher mortality.

Method: The main objective of this study is to estimate the association between perioperative values of PPI and haemoglobin levels. The secondary objectives are to evaluate PPI in patients with low hb in relation to mean arterial blood pressure (MAP), and evaluate changes in PPI with patients with low and normal hb in relation to transfusion with blood products.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: June 1, 2019
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Orthopedic surgery patients with fracture of the hip, booked in the electronic patient record for operation with procedural codes:KNFB02 HNFJ81 KNFJ51 KNFJ52 KNFJ70

• Acute abdominal surgery patients booked in the electronic patient record for operation with procedural codes:KJAH01 KJAH00

Exclusion Criteria:

• No sampling of PPI registered

• Foreign/temporary civil registration number

• Already included in cohort

Related Conditions & MeSH terms

• Anastomotic Leak
• Fracture of Hip
• Hip Fractures
• Ileus
• Perforated Viscus

Locations

Country	Name	City	State
Denmark	Department of Anesthesia, Hvidovre Hospital	Hvidovre	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral perfusion index	Absolute PPI levels	Perioperative with 5 minute interval
Primary	Haemoglobin level	Measurement of haemoglobin by blood sample or artery gas.	Time interval: From 3 hours preoperative to 10 hours postoperative
Secondary	Evaluation of Peripheral perfusion index in patients with high vs. low haemoglobin levels in relation to mean arterial blood pressure (MAP).	High vs. low hb defined as 6,0 < hb > 6,0. Absolute PPI levels perioperative with a 5 minute interval. Absolute values of MAP measured perioperative with a 5 minute interval.	Perioperative
Secondary	Proportion of transfusion with blood products in patients with perioperative high vs. low haemoglobin levels.	High vs. low hb defined as 6,0 < hb > 6,0. Blood transfusion measured as total amount used perioperatively.	Perioperative
Secondary	Evaluation of peripheral perfusion index changes in patients with perioperative high vs. low haemoglobin levels in relation to transfusion with blood products .	High vs. low hb defined as 6,0 < hb > 6,0. Absolute PPI levels perioperative measured with a 5 minute interval. Blood transfusion measured as total amount used perioperatively.	Perioperative