Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery
NCT03438383
Atelectasis, Body Weight
View Trial DetailsNCT Number: NCT07542093
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
The global escalation of obesity creates distinct challenges for respiratory management in the ICU. In the morbidly obese population, increased chest wall mass and cranial displacement of the diaphragm significantly elevate pleural pressure. This physiological burden leads to widespread atelectasis in dependent lung zones and a marked reduction in functional residual capacity, resulting in a cycle of atelectrauma and severe ventilation-perfusion mismatch. Traditional monitoring tools are inadequate for managing these patients: chest X-rays lack sensitivity for detecting posterior, dependent-zone collapse, Computed Tomography (CT) carries prohibitive transport risks and radiation exposure, and conventional compliance curves provide only global information that obscures regional heterogeneity. Bedside Lung Ultrasound (LUS) offers a paradigm shift by enabling real-time regional visualization of sub-pleural pathology, allowing clinicians to identify the transition from tissue-like consolidation to normal aeration at the bedside.
This study aims to evaluate the clinical utility of bedside LUS as a real-time, radiation-free monitoring tool for assessing the effectiveness of Lung Recruitment Maneuvers (LRMs) and guiding optimal Positive End-Expiratory Pressure (PEEP) titration in mechanically ventilated obese adults.
Study Procedures:
Scanning is performed by the same trained investigator throughout the study to reduce inter-observer variability, and safety stop criteria are in place to abort the maneuver if patients exhibit severe desaturation, hemodynamic instability, or signs of pneumothorax.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline (immediately before the recruitment maneuver) to 15-20 minutes after establishing optimal PEEP
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.
Assiut University
Other
Use of Bedside Lung Ultrasound to Monitor Lung Recruitment Maneuvers During Mechanical Ventilation in Obese Patients
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