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

NCT ID: NCT03828565

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-10-31

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.

Conditions

Cardiac Flow

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

ScvO2 group

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

Group Type: ACTIVE_COMPARATOR

ScvO2 Perioperative continue monitoring

Intervention Type: PROCEDURE

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ScvO2 Perioperative continue monitoring

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Olivier Arnaud

Role: STUDY_DIRECTOR

APHM

Locations

Laurent Zieleskiewicz

Marseille, PACA, France

Countries

France

Central Contacts

Laurent ZIELESKIEWICZ, Dr

Role: CONTACT

laurent.zieleskiewicz@ap-hm.fr

+33 491965377

Facility Contacts

Laurent Zieleskiewicz, Dr

Role: primary

laurent.zieleskiewicz@ap-hm.fr

+33 491965377

References

Pastene B, Bernat M, Baumstark K, Bezulier K, Gricourt Y, De Guibert JM, Charvet A, Colin M, Leone M, Zieleskiewicz L. OCOSO2: study protocol for a single-blinded, multicentre, randomised controlled trial assessing a central venous oxygen saturation-based goal-directed therapy to reduce postoperative complications in high-risk patients after elective major surgery. Trials. 2023 Oct 11;24(1):659. doi: 10.1186/s13063-023-07689-z.

Reference Type: DERIVED

PMID: 37821968 (View on PubMed)

Other Identifiers

IDRCB

Identifier Type: OTHER

Identifier Source: secondary_id

2018-37

Identifier Type: -

Identifier Source: org_study_id