An observational study in Morbid Obesity, Obesity and Respiratory Failure, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Assiut University · Observational
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.
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.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's planned enrollment of 45 is below the median of 78 across 306 observational studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Adult patients with a BMI ≥ 33 kg/m² requiring invasive mechanical ventilation in the respiratory ICU. All participants in this single-cohort study will undergo a standardized, stepwise pressure-controlled lung recruitment maneuver reaching a peak inspiratory pressure of 35 cmH₂O and a PEEP of 20 cmH₂O. This is immediately followed by a decremental PEEP titration. The primary observational focus is the use of a bedside 12-zone Lung Ultrasound (LUS) scan to monitor real-time regional lung re-aeration, calculate total LUS scores before and after the maneuver, and identify the optimal PEEP based on lung closing pressures.
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.
Time frame: Baseline (immediately before the recruitment maneuver) to 15-20 minutes after establishing optimal PEEP
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assiut University