Preoperative Evaluation of Microcirculation for Prediction of Complications After Cardiac Surgery (MONS)

U

University Hospital, Angers

Status

Completed

Conditions

Extracorporeal Circulation; Complications

Treatments

Procedure: Microvascular reactivity evaluation

Study type

Interventional

Funder types

Other

Identifiers

NCT03631797
2018-A2341-54

Details and patient eligibility

About

Cardiac surgery is responsible for many complications. Microcirculation is involved in many of them. The objective of this study is to prospectively investigate the prognostic value of preoperative microcirculatory assessment in patients scheduled for cardiac surgery with CPB for the occurrence of postoperative complications. Microvascular dysfunction is suspected of being involved in postoperative psycho-cognitive decline. The influence of microcirculation on the evolution of psycho-cognitive assessment is also analyzed in this study.

Full description

Eligible patients are included during the preoperative assessment. Written consent is signed after complete explanation of the protocol. Patient characteristics as treatments, medical history, and EuroSCORE II are registered. Moreover, intraoperative data is collected. Psycho-cognitive and functional evaluation is made preoperatively. Microcirculation is evaluated for each patient before surgery. Complications are registered at the end of hospital stay. Psycho-cognitive and functional evaluation is repeated by call 30 days after the surgery.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Valvular ou coronary elective cardiac surgery under cardiopulmonary bypass
  • Fair skin phototype
  • Ability to understand the study goal, no dementia.
  • Affiliation to the French National Healthcare System
  • Voluntary patients who have signed an informed consent

Exclusion criteria

  • Emergency surgery
  • Multiple procedures, combined surgery (valvular and coronary)
  • Single aortic surgery
  • Patient already included in the study (second surgery)
  • Patients protected by decision of law

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Microvascular reactivity evaluation
Experimental group
Description:
Patients referred for a preoperative arterial palmar arches assessment before cardiac valvular or coronary surgery. Intervention is measurement of microvascular reactivity with a laser speckle contrast imaging before surgery.
Treatment:
Procedure: Microvascular reactivity evaluation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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