Actively Recruiting
Lung Ultrasound-guided Hemodynamic Optimization in Major Non-cardiac Surgery: a Randomized Control
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-05-28
350
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of lung ultrasound-guided hemodynamic optimization compared to standard care in adults undergoing major non-cardiac surgery such as abdominal, orthopedic, or vascular surgery. The study aims to reduce postoperative organ failure by improving vascular filling decisions during surgery. This approach addresses concerns that current methods of guiding vascular filling have limitations and no gold standard monitoring device exists for intraoperative use. Participants are randomly assigned to either a control group receiving usual care with noradrenaline and vascular filling guided by stroke volume, or an experimental group where lung ultrasound is used to detect B-lines indicating fluid overload during vascular filling. The intervention group follows an algorithm that includes stopping vascular filling if stroke volume does not increase sufficiently and monitors the appearance of B-lines to avoid fluid overload. This study represents a Phase 3 randomized trial without masking. During the study, patients will be monitored intraoperatively with stroke volume measurements and lung ultrasound scans. Researchers will track postoperative organ failure within 7 days and length of hospital stay. Other evaluations include adherence to the vascular filling protocol and assessment of fluid tolerance. Participants must be followed and assessed throughout surgery and postoperatively to measure outcomes and complications related to hemodynamic management.
CONDITIONS
Brief Title
Lung Ultrasound-guided Hemodynamic Optimization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years old
- Undergoing abdominal, orthopedic, or vascular surgery with general anesthesia
- ASA score of II or higher
- Estimated surgery duration longer than 2 hours
- At least two of the following comorbidities: age over 50, hypertension, heart disease, ECG abnormality, acute pulmonary edema, smoking, stroke, peripheral arterial disease, diabetes (insulin dependent or non-insulin dependent), ascites, chronic renal failure
- Signed informed consent
- Affiliation to a social security scheme
You will not qualify if you...
- Severe untreated or uncontrolled hypertension
- Preoperative renal failure requiring dialysis
- Acute heart failure
- Acute coronary insufficiency
- Vascular surgery involving renal plasty
- Cardiac surgery
- Preoperative shock
- Refusal to participate
- Pregnant, breastfeeding, or parturient women
- Patient under legal guardianship or private law
- Acute respiratory distress syndrome as per Berlin definition
- Respiratory distress not explained by cardiac failure or fluid overload
- PaO2/FiO2 ratio less than or equal to 300 mm Hg on mechanical ventilation
- Chronic respiratory failure requiring home oxygen therapy
- Chronic interstitial lung disease
- Presence of acoustic barriers such as pneumothorax, subcutaneous emphysema, pleural calcifications, chest bandage, or gunshot shrapnel
- Participation in other interventional drug research
- Surgical areas overlapping with lung ultrasound investigation sites
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of surgery and immediate recovery period
Participants undergo major non-cardiac surgery during which hemodynamic management is provided either by usual care or guided by lung ultrasound and vascular filling protocols.
1 surgery visit (in-person)
Duration - 7 days
Participants are monitored for postoperative organ failure and recovery during the 7 days following surgery.
Daily visits or assessments during hospital stay
Trial Site Locations
Total: 1 location
1
CHU Amiens
Amiens, France, 80054
Actively Recruiting
Research Team
S
Stéphane BAR, DR
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here