Peripheral and Mesenteric Perfusion in Elective Surgical Patients

Sponsor
Hvidovre University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03395483
Collaborator
(none)
30
1
17.7
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Investigating the Peripheral Perfusion Index; Correlations Between Peripheral and Mesenteric Perfusion in Elective Surgical Patients
Actual Study Start Date :
Apr 10, 2018
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Peripheral perfusion index and mesenteric perfusion changes from baseline after haemodynamic challenges [Perioperatively]

    Association between PPI and mesenteric perfusion

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult

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

  • Written informed consent

Exclusion Criteria:
  • No consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anæstesiologisk afdeling, Hvidovre hospital Hvidovre Denmark 2650

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jakob Højlund, MD, Senior Hospital Physician, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT03395483
Other Study ID Numbers:
  • H-17004663
First Posted:
Jan 10, 2018
Last Update Posted:
Nov 1, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jakob Højlund, MD, Senior Hospital Physician, Hvidovre University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2019