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Decrease of Post-operative Complications by SCVO2 Monitoring an Optimisation of Cardiac Flow (OCOSO2)

Primary Purpose

Cardiac Flow

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ScvO2 Perioperative continue monitoring
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Flow

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >50 years old
  • ASA score ≥ 2
  • requiring a major intra-abdominal scheduled surgery
  • lasting more than 90 min
  • in the visceral surgery, vascular surgery, urological surgery and gynecological surgery sectors

Exclusion Criteria:

  • <18 years old
  • Pregnant or brest feeding patients
  • no consentement
  • Unstable acute pathology at the time of surgery (acute heart, respiratory or renal failure, severe sepsis or septic shock, hemorrhagic shock);
  • rhythm disorders type ACFA early intervention;
  • Palliative surgery, ASA 5;
  • Patient under guardianship or curatorship.

Sites / Locations

  • Laurent Zieleskiewicz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

ScvO2 group

Control group

Arm Description

ScvO2 and Pulse Pressure Variation (PPV) : every 30 min (%) ScvO2 Evolution in case of corrective maneuver (%) PPV evolution in case of filling test (%)

End-systolic Volume (ESV) : every 30 min (mL) ESV evolution in case of filling test (%)

Outcomes

Primary Outcome Measures

Difference of the CCI score at day 5 between patients of ScvO2 group and patient of control group.
CCI score : Comprehensive Complication Index. Allow to integrate all the postoperative complications and their respectives severities. From 0 (No complication) to 100 (death of the patient)

Secondary Outcome Measures

Full Information

First Posted
January 31, 2019
Last Updated
February 1, 2019
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT03828565
Brief Title
Decrease of Post-operative Complications by SCVO2 Monitoring an Optimisation of Cardiac Flow
Acronym
OCOSO2
Official Title
Decrease of Post-operative Complications by SCVO2 Monitoring an Optimisation of Cardiac Flow : Multicentric Randomized Control in Single Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In operating theater, one of the bigger purpose of anesthetist-resuscitator is to optimize vascular filling (VF) because of a failure or an excess of filling is deleterious for the patient. Several studies have assessed the traditionnal VF based on the clinic and the VF guided by quantitative critereas. Thus studies have showed a decrease of morbidity and duration of patients' stay whose the VF was guided even on the long term. So, formal recommandations of experts (FRE) on the perioperative filling strategy of the SFAR ( Anesthesia and Resuscitation Francophone Society) advise to titrate the perioperative vascular filling of high risk patients guiding on a mesure of end-systolic volume (ESV). The inscrease of ESV answering to filling confirmed the VF realized is relevant and authorized its pursuite while the absence of an increase of the ESV after a filling test signifies the useless and deleterious character of this one. The optimization of perioperative hemodynamics consists in adapting the patient's cardiac output to his metabolic needs. ETO, Swan-Ganz: limit of its application to the routine. The central venous oxygen saturation (ScvO2) is simple and safe, the evaluation of the adjustment of O2 inputs compared to the needs. The industry has developed continuous monitoring systems by reflection spectrophotometry using optical fibers installed in the central venous pathways. In daily practice, the stricto sensu application of FRE leads to administering an VF up to the limit of the preload dependence without evaluating the adequacy of the cardiac output, which is not a physiological situation. This filling is therefore sometimes performed solely on the criteria of preload dependence while it is potentially deleterious for the patient. No study has compared a strategy based on the use of ScvO2 and preload dependence with current recommendations based solely on preload dependence. Our hypothesis is that the continuous monitoring of the ScvO2 in the superior cave territory in intraoperative would allow to detect the patients with an inadequacy of the cardiac output and thus to select the only ones requiring a vascular filling. This would reduce postoperative complications related to overfilling, without exposing the patient to episodes of tissue hypoperfusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Flow

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ScvO2 group
Arm Type
Active Comparator
Arm Description
ScvO2 and Pulse Pressure Variation (PPV) : every 30 min (%) ScvO2 Evolution in case of corrective maneuver (%) PPV evolution in case of filling test (%)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
End-systolic Volume (ESV) : every 30 min (mL) ESV evolution in case of filling test (%)
Intervention Type
Procedure
Intervention Name(s)
ScvO2 Perioperative continue monitoring
Intervention Description
ScvO2 Perioperative continue monitoring with PreSep® system. If SvcO2 is less than 65% or decreases by more than 10% of its base value, the other parameters affecting ScvO2 (BIS (40-60% objective), Hb (objective> 8g / dL), SaO2 (objective> 94%)) are evaluated. If, after correcting for these parameters, the ScvO2 is not corrected, the preload-dependence parameters are evaluated (variation of the pulsed pressure) to guide the vascular filling: VF of 250 mL of crystalloids if PPV> 13%, norepinephrine if PPV<9%, reassess if PPV between 9 and 13%. If VF or norepinephrine does not correct ScvO2 (> 65%), a measurement of arterial lactate is performed. If lactatemia is> 2 mmol / L, a positive inotrop is introduced after ETO if possible. If lactatemia is <2 mmol / L, a return to the evaluation phase of the parameters influencing ScvO2 is necessary.
Primary Outcome Measure Information:
Title
Difference of the CCI score at day 5 between patients of ScvO2 group and patient of control group.
Description
CCI score : Comprehensive Complication Index. Allow to integrate all the postoperative complications and their respectives severities. From 0 (No complication) to 100 (death of the patient)
Time Frame
Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >50 years old ASA score ≥ 2 requiring a major intra-abdominal scheduled surgery lasting more than 90 min in the visceral surgery, vascular surgery, urological surgery and gynecological surgery sectors Exclusion Criteria: <18 years old Pregnant or brest feeding patients no consentement Unstable acute pathology at the time of surgery (acute heart, respiratory or renal failure, severe sepsis or septic shock, hemorrhagic shock); rhythm disorders type ACFA early intervention; Palliative surgery, ASA 5; Patient under guardianship or curatorship.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent ZIELESKIEWICZ, Dr
Phone
+33 491965377
Email
laurent.zieleskiewicz@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier Arnaud
Organizational Affiliation
APHM
Official's Role
Study Director
Facility Information:
Facility Name
Laurent Zieleskiewicz
City
Marseille
State/Province
Paca
ZIP/Postal Code
13354
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Zieleskiewicz, Dr
Phone
+33 491965377
Email
laurent.zieleskiewicz@ap-hm.fr

12. IPD Sharing Statement

Learn more about this trial

Decrease of Post-operative Complications by SCVO2 Monitoring an Optimisation of Cardiac Flow

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