Risk Factors for Postoperative Complications in Major Non-cardiac Surgery: Post-hoc Analysis of the OPHIQUE Multicentre Study

NCT ID: NCT05824260

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-23
• Study Completion Date: 2023-07-31

Brief Summary

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).

Conditions

Goal Directed Therapy; Postoperative Morbidity; Individualised Target; Postopera Mortality

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

patients with complications

No interventions assigned to this group

patients without complication

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens-Picardie

Amiens, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Stéphane Bar, MD

Role: CONTACT

bar.stephane@chu-amiens.fr

03 22 08 79 06

Facility Contacts

Stephane BAR

Role: primary

bar.stephane@chu-amiens.fr

03 22 08 79 06

Other Identifiers

PI2022_843_0099

Identifier Type: -

Identifier Source: org_study_id