Bedside Lung Ultrasound to Monitor Lung Recruitment in Obese Patients (NCT07542093) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Bedside Lung Ultrasound to Monitor Lung Recruitment in Obese Patients
45 participantsStarted 2026-05
Plain-language summary
Patients with morbid obesity who require a breathing machine (mechanical ventilator) in the Intensive Care Unit (ICU) frequently experience partial lung collapse. This happens because the extra weight of the chest and abdomen presses on the lungs, reducing their capacity and making it difficult to maintain adequate oxygen levels. To address this, doctors often perform a standard lung recruitment maneuver, which involves temporarily increasing the air pressure from the ventilator to gently pop open the collapsed lung areas. However, standard bedside monitoring tools make it difficult to see exactly how well the different regions of the lungs are reopening.
This prospective observational study aims to evaluate the use of Bedside Lung Ultrasound (LUS), which is a safe, radiation-free imaging tool, to monitor how well the lungs respond to these maneuvers in real-time.
During the study, researchers will use a standardized 12-zone ultrasound scan to examine the lungs of mechanically ventilated adult patients (BMI ≥ 33 kg/m²) before, during, and after a step-by-step lung recruitment maneuver. By calculating a "Total Lung Ultrasound Score," the medical team can directly visualize and measure the transition from collapsed tissue to normal, aerated lung tissue. Furthermore, the ultrasound will be used during a step-down pressure phase to help identify the patient's "optimal PEEP" (Positive End-Expiratory Pressure), which is the exact customized pressure needed to keep the lungs open after the maneuver is complete, thereby improving oxygenation and minimizing the risk of lung injury.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients aged \>18 years
* BMI ≥ 33 kg/m² (morbid obesity)
* Intubated and receiving invasive mechanical ventilation for any indication (elective surgery, respiratory failure, post-operative ICU admission)
* Expected duration of mechanical ventilation ≥ 6 hours
* Hemodynamically stable at enrollment: Mean Arterial Pressure (MAP) ≥ 65 mmHg without escalating vasopressor support
* SpO₂ ≥ 85% on current ventilator settings
* Written informed consent obtained from patient or legal guardian
Exclusion Criteria:
* Known or suspected pneumothorax or bullous emphysema (contraindication to recruitment maneuvers)
* Severe hemodynamic instability: MAP \< 60 mmHg or requiring high-dose vasopressors (norepinephrine \> 0.3 mcg/kg/min)
* Active bronchopleural fistula
* Recent thoracic or cardiac surgery (within 48 hours) where high airway pressures are contraindicated
* Raised intracranial pressure (ICP) or known severe traumatic brain injury
* Confirmed ARDS with PaO₂/FiO₂ ratio \< 100 mmHg (severe ARDS, where recruitment strategy differs significantly)
* Chest wall deformity or subcutaneous emphysema that precludes reliable lung ultrasound assessment
* Refusal of consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Total Lung Ultrasound Score (LUS)
Timeframe: Baseline (immediately before the recruitment maneuver) to 15-20 minutes after establishing optimal PEEP