About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population consists of adult patients (aged \>18 years) with morbid obesity (BMI ≥ 33 kg/m²) who are admitted to the respiratory Intensive Care Unit (ICU) at Assiut University Hospital. Patients must be intubated and receiving invasive mechanical ventilation for an expected duration of at least 6 hours, while maintaining hemodynamic stability at enrollment.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in Total Lung Ultrasound Score (LUS)
The Total Lung Ultrasound Score (LUS) assesses regional lung aeration using a 12-zone scanning protocol. Each of the 12 zones is scored from 0 (normal aeration) to 3 (complete collapse/tissue-like consolidation). The total score is the sum of all 12 zones, ranging from 0 to 36, where a higher score indicates worse lung aeration. This measure evaluates the quantitative change in real-time regional re-aeration resulting from the lung recruitment maneuver.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: