BridgeMD
New treatment option for Lung Ultrasound
Official title Lung Ultrasound-guided Hemodynamic Optimization
ClinicalTrials.gov ID: NCT05481723
What this study is testing
What is noradrenaline and vascular filling?
noradrenaline and vascular filling is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for lung ultrasound.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The formalized expert recommendation of the French Society of Anesthesia and Intensive Care recommends guiding vascular filling by measuring the stroke volume (SV) in surgical patients considered at high risk. Vascular filling should be continued in the event of preload dependence and stopped in the event of the appearance of preload independence.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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...
- Signed consent.
- Affiliation to a social security scheme.
- 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 treatment drug research.
- Surgical fields covering the sites of investigation in lung ultrasound.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.