Using lung ultrasound to optimize fluid management in high-risk surgical patients
Lung Ultrasound-guided Hemodynamic Optimization in Major Non-cardiac Surgery: a Randomized Control
This study tests if using lung ultrasound to manage fluid levels can help high-risk surgical patients recover better and avoid complications after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT05481723 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of lung ultrasound to guide hemodynamic optimization in patients undergoing non-cardiac surgery. It aims to assess whether measuring stroke volume through lung ultrasound can improve patient outcomes by preventing vascular overload and reducing postoperative complications. The study will involve administering noradrenaline and monitoring vascular filling based on ultrasound findings. The goal is to establish a more effective method for managing fluid therapy in high-risk surgical patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old undergoing abdominal, orthopedic, or vascular surgery with a duration of more than 2 hours and with at least two comorbidities.
Not a fit: Patients with severe untreated hypertension, acute heart failure, or those undergoing cardiac surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery times and reduced complications for patients undergoing high-risk surgeries.
How similar studies have performed: Previous studies have shown promising results using lung ultrasound in various medical fields, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age\> 18 years old * Abdominal, orthopaedic or vascular surgery with general anaesthesia * Patient of legal age ≥ 18 years. * ASA score ≥ II * Estimated duration of surgery \> 2 hours * At least two of the following comorbidities (age \> 50 years, hypertension, heart disease, electrocardiogram (ECG) abnormality, acute pulmonary oedema, smoking, stroke, peripheral arterial disease, non-insulin dependent or insulin dependent diabetes, ascites, chronic renal failure) * Signed consent. * Affiliation to a social security scheme. Exclusion Criteria: * Severe untreated or unbalanced hypertension on treatment. * Preoperative renal failure on dialysis. * Acute heart failure. * Acute coronary insufficiency. * Vascular surgery with renal plasty. * Cardiac surgery. * Preoperative shock. * Refusal of patient participation. * Pregnant, parturient or breastfeeding woman. * Patient under guardianship or private law. * Acute respiratory distress syndrome according to the Berlin definition * respiratory distress not fully explained by cardiac failure or increased blood volume, * PaO2/FiO2 ratio ≤ 300 mm Hg on mechanical ventilation (invasive or non-invasive) * Chronic respiratory failure with home oxygen therapy. * Chronic interstitial lung disease * Presence of an acoustic barrier (pneumothorax, subcutaneous emphysema, pleural calcifications, chest bandage, gunshot shrapnel...) * Participation in other interventional drug research. * Surgical fields covering the sites of investigation in lung ultrasound.
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Stéphane BAR, DR
- Email: bar.stephane@chu-amiens.fr
- Phone: 03 22 08 79 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.