Peripheral and Mesenteric Perfusion in Elective Surgical Patients

NCT ID: NCT03395483

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-10
• Study Completion Date: 2019-10-01

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.

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.

Conditions

Peripheral Perfusion; Bowel Ischemia; Colorectal Surgery; Haemodynamic Instability

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Haemodynamic monitoring

Intervention Type: OTHER

see Group description

Interventions

Haemodynamic monitoring

see Group description

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jakob Højlund

MD, Senior Hospital Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marianne Agerskov, MD, Research Fellow

Role: STUDY_CHAIR

Department af Anaesthesia, Hvidovre Hospital, University of Copenhagen

Jakob Højlund, Chief Physician

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesia, Hvidovre Hospital, University of Copenhagen

Nicolai Bang Foss, Clinical Professor, DMSc.

Role: STUDY_DIRECTOR

Department of Anaesthesia, Hvidovre Hospital, University of Copenhagen

Henrik Sørensen, MD, DMSc.

Role: STUDY_CHAIR

Department of Anaesthesiology, Abdominal Centre, Rigshospitalet, University of Copenhagen

Niels Secher, Professor, DMSc.

Role: STUDY_CHAIR

Department of Anaesthesiology, Abdominal Centre, Rigshospitalet, University of Copenhagen

Locations

Anæstesiologisk afdeling, Hvidovre hospital

Hvidovre, , Denmark

Countries

Denmark

Other Identifiers

H-17004663

Identifier Type: -

Identifier Source: org_study_id