Risk Factors for Postoperative Complications in Major Non-cardiac Surgery: Post-hoc Analysis of the OPHIQUE Multicentre Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Goal Directed Therapy, Postoperative Morbidity, Individualised Target, Postopera Mortality. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Post-operative morbidity and mortality is related to many factors related to the patient's condition, the intra-operative period and the optimisation of intra-operative haemodynamic and respiratory parameters. Many studies have looked at the determinants and factors that increase postoperative complications. However, these have been randomised studies looking at one parameter in particular. This analysis would be the first to investigate the determinants of postoperative complications in a large population of patients undergoing major non-cardiac surgery. This is a post-hoc analysis of patients included in the OPHIQUE study, whose main objective was to evaluate intraoperative haemodynamic management guided by a marker of tissue hypoperfusion (the respiratory quotient).
Primary outcome measures
- NUmber of risk factors associated with postoperative morbidity in major non-cardiac surgery [Time frame: 2 years]
- Number of risk factors associated with postoperative mortality in major non-cardiac surgery [Time frame: 2 years]
Secondary outcome measures (1)
- Number of risk factors associated with the occurrence of postoperative renal dysfunction. [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Abdominal, orthopaedic or vascular surgery under general anaesthesia and with an estimated duration of surgery > 2 hours
- Adult patients (age ≥ 18 years)
- ASA score ≥ II
- Patient with at least two of the following comorbidities: age > 50 years, high blood pressure (HTA), heart failure, ECG abnormality, smoking, stroke, transient ischemic attack (TIA), peripheral arterial disease (PAD), insulin-dependent or non-insulin-dependent diabetes mellitus (NIDDM), ascites, chronic renal failure (CRF)
- Signature of the consent form
- Affiliation to a social security scheme
Exclusion criteria
- Severe untreated or unbalanced hypertension
- Preoperative renal failure on dialysis
- Acute heart failure
- Acute coronary insufficiency
- Vascular surgery with renal plasty
- Cardiac surgery
- Permanent laparoscopy
- Chronic respiratory failure with home oxygen therapy
- Acute respiratory distress syndrome with FiO2>60%.
- Preoperative shock
- Surgery under spinal anaesthesia and epidural only
- Refusal to participate by the patient
- Pregnant, parturient or breastfeeding women
- Patients under guardianship or curators, under court protection or deprived of public rights
- The patient already included in another therapeutic trial with an experimental molecule
- Emergency surgery
- Patients who do not want their personal data to be used in the framework of the research
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- CHU Amiens-Picardie — Amiens
Identifiers
NCT: NCT05824260 · PI2022_843_0099