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Peripheral and Mesenteric Perfusion in Elective Surgical Patients

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ClinicalTrials.gov Identifier: NCT03395483
Recruitment Status : Completed
First Posted : January 10, 2018
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jakob Højlund, Hvidovre University Hospital

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
Peripheral Perfusion Bowel Ischemia Colorectal Surgery Haemodynamic Instability 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.

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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 : April 10, 2018
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : October 1, 2019

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




Primary Outcome Measures :
  1. Peripheral perfusion index and mesenteric perfusion changes from baseline after haemodynamic challenges [ Time Frame: Perioperatively ]
    Association between PPI and mesenteric perfusion



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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
x
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395483


Locations
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Denmark
Anæstesiologisk afdeling, Hvidovre hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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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
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Responsible Party: Jakob Højlund, MD, Senior Hospital Physician, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03395483    
Other Study ID Numbers: H-17004663
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jakob Højlund, Hvidovre University Hospital:
peripheral perfusion
Haemodynamic Instability
mesenteric bloodflow
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes