Peripheral and Mesenteric Perfusion in Elective Surgical Patients

NCT03395483 | Completed DMC

• 1 other identifier: H-17004663
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Perfusion; Bowel Ischemia; Colorectal Surgery; Haemodynamic Instability

Keywords

peripheral perfusion; Haemodynamic Instability; mesenteric bloodflow

Outcome Measures

Primary Outcomes (1)

• Peripheral perfusion index and mesenteric perfusion changes from baseline after haemodynamic challenges

  Association between PPI and mesenteric perfusion

  Perioperatively

Study Arms (1)

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

Interventions

Haemodynamic monitoring OTHER

see Group description

Elective, adult colorectal surgical patients

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

x

You may qualify if:

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

You may not qualify if:

• No consent

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Anæstesiologisk afdeling, Hvidovre hospital

Hvidovre, 2650, Denmark

Location

Study Officials

• Marianne Agerskov, MD, Research Fellow

  Department af Anaesthesia, Hvidovre Hospital, University of Copenhagen

  STUDY CHAIR

• Jakob Højlund, Chief Physician

  Department of Anaesthesia, Hvidovre Hospital, University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Nicolai Bang Foss, Clinical Professor, DMSc.

  Department of Anaesthesia, Hvidovre Hospital, University of Copenhagen

  STUDY DIRECTOR

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Senior Hospital Physician

Study Record Dates

• First Submitted: December 16, 2017
• First Posted: January 10, 2018
• Study Start: April 10, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 1, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)