Peripheral and Mesenteric Perfusion in Elective Surgical Patients

Investigating the Peripheral Perfusion Index; Correlations Between Peripheral and Mesenteric Perfusion in Elective Surgical Patients

An important goal of haemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion and oxygenation. The mesenteric haemodynamic response to circulatory shock is complex, and diagnosis of bowel ischaemia poses significant difficulty. Assuming blood flow is diverted from the peripheral tissue and the gastrointestinal tract to vital organs, during circulatory shock, an objective, simple and non-invasive method of detecting peripheral tissue perfusion impairment might detect this at an early stage.

The peripheral perfusion index (PPI) reflects changes in peripheral perfusion and laser doppler flowmetry allows measurement of bowel tissue perfusion.

The aim of this study is to explore the association between changes in peripheral and intestinal perfusion in patients undergoing elective colorectal surgery exposed to intraoperative haemodynamic challenges.

Study Overview

• Status: Completed
• Conditions: Colorectal Surgery; Peripheral Perfusion; Bowel Ischemia; Haemodynamic Instability
• Intervention / Treatment: Other: Haemodynamic monitoring

Detailed Description

An important goal of haemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion and oxygenation, but in clinical practice, monitoring and resuscitation is routinely based on measuring of blood pressure and heart rate, which might be inadequate endpoints for optimal resuscitation. Haemodynamic management targeting cardiac output and stroke volume (SV), and to some extent, flow and tissue perfusion is feasible when applying minimally-invasive or non-invasive methods, but has been limited to a narrow number of critically ill patients and to the intraoperative setting. Another approach to resuscitation is aimed at flow and perfusion of vital organs. Ideally, measurements would be done directly on these organs, but no feasible methods exist. Assuming blood flow is diverted from the peripheral tissue and the gastrointestinal tract to vital organs, during circulatory shock, an objective, simple and non-invasive method of detecting peripheral tissue perfusion impairment might detect this at an early stage. The peripheral perfusion index (PPI) is derived from the photoelectric plethysmographic pulse oximetry signal, which all patients are monitored by perioperatively to assess arterial oxygen saturation. The PPI is a numerical non-invasive measure representing the ratio between the pulsatile (arterial) and non-pulsatile component of the light reaching the pulse oximeter, and PPI decreases in states of hypoperfusion. PPI reflects changes in peripheral perfusion and blood volume and decreased peripheral perfusion determined by PPI predicts surgical complications and morbidity in acute surgical and septic shock patients.

The mesenteric haemodynamic response to circulatory shock is complex, and diagnosis of bowel ischaemia poses significant difficulty for the clinicians due to its non specific presentations and lack of a simple diagnostic test. In patients undergoing colorectal surgery for malignancy, laser doppler flowmetry allows measurement of bowel tissue perfusion.

The aim of this study is to explore the association between changes in peripheral and intestinal perfusion in patients undergoing elective colorectal surgery exposed to intraoperative haemodynamic challenges.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Anæstesiologisk afdeling, Hvidovre hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 118 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

x

Description

Inclusion Criteria:

• Adult
• Elective colorectal surgery, low anterior resection of the colon, sigmoid colectomy or right hemicolectomy
• Written informed consent

Exclusion Criteria:

• No consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elective, adult colorectal surgical patients; All patients will be monitored by the non-invasive Masimo Radical7 pulseoximeter (Masimo, Irvine, CA, USA) measuring PPI and the MoorVMS-LDF (Moor Instruments Ldt., Axminster, UK) measuring mesenteric tissue blood flow using doppler flowmetry. Patients will be subjected to a haemodynamic challenge using anti-trendelenburg position.	Other: Haemodynamic monitoring; see Group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral perfusion index and mesenteric perfusion changes from baseline after haemodynamic challenges	Association between PPI and mesenteric perfusion	Perioperatively

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Study Chair: Marianne Agerskov, MD, Research Fellow, Department af Anaesthesia, Hvidovre Hospital, University of Copenhagen; Principal Investigator: Jakob Højlund, Chief Physician, Department of Anaesthesia, Hvidovre Hospital, University of Copenhagen; Study Director: Nicolai Bang Foss, Clinical Professor, DMSc., Department of Anaesthesia, Hvidovre Hospital, University of Copenhagen; Study Chair: Henrik Sørensen, MD, DMSc., Department of Anaesthesiology, Abdominal Centre, Rigshospitalet, University of Copenhagen; Study Chair: Niels Secher, Professor, DMSc., Department of Anaesthesiology, Abdominal Centre, Rigshospitalet, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2018
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: December 16, 2017
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (Actual): January 10, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: peripheral perfusion; Haemodynamic Instability; mesenteric bloodflow
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: H-17004663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No