CHU Amiens
Amiens, 80480, France
Location status: Recruiting
NCT Number: NCT07595926
Acute respiratory distress syndrome is characterized by heterogeneous lung injury, with dependent regions often collapsed and non-dependent regions relatively well-aerated, forming the so called "baby lung." Mechanical ventilation, while essential, can induce additional lung injury (VILI) via overdistension (baro/volutrauma) or repetitive alveolar collapse (atelectrauma). Protective ventilation strategies with low tidal volumes (VT 6-8 mL/kg predicted body weight, PBW) reduce mortality, but their efficacy relies on accurate PBW estimation, which is derived from patient height. In critical care, height measurement is often challenging, and common methods such as visual estimation or tape measurement can be inaccurate, leading to inappropriate VT settings and increased risk of lung stress and VILI. Alternative methods, including heel-to-knee distance and laser measurement, may offer more precise PBW estimation, yet their impact on lung mechanics in ARDS remains unexplored. This study addresses the knowledge gap by evaluating whether differences in height measurement methods significantly affect lung stress, tidal volume distribution, and ventilatory mechanics in ARDS patients.
Patients' heights will be measured using five methods (stadiometer, visual, tape, laser, heel-to knee). Corresponding PBW and tidal volumes (VT = 6 mL/kg PBW) will be calculated and applied in randomized order, each for 30 minutes. Lung stress, ventilatory mechanics, gas exchange, and regional ventilation distribution will be assessed for each VT setting, preceded by a short alveolar recruitment maneuver. During the study, continuous monitoring of hemodynamics and oxygenation will be performed.
Ventilatory parameters including plateau pressure, driving pressure, and transpulmonary pressures will be recorded. Electrical impedance tomography will assess regional tidal volume distribution. Each patient's participation is limited to approximately two hours with no further follow-up.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Amiens, 80480, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with ARDS will have their height measured using five different methods:
stadiometer (reference), visual estimation, measuring tape, infrared laser, and heel-to-knee distance. For each height, the predicted body weight (PBW) and corresponding tidal volume (VT = 6 mL/kg PBW) will be calculated and applied in a randomized order, each for 30 minutes. During each VT period, lung stress (end-inspiratory transpulmonary pressure), ventilatory mechanics, gas exchange, and regional ventilation distribution (assessed using electrical impedance tomography) will be assessed. Prior to each VT application, a short alveolar recruitment maneuver will be performed to standardize lung volume.
Time frame: one day
Pulmonary stress assessed by measuring end-inspiration transpulmonary pressure using a balloon esophageal probe.
Time frame: one day
Agreement of measured height across the different height-measurement methods.
Time frame: one day
Agreement of predicted body weight across the different height-measurement methods.
Time frame: one day
Agreement of tidal volume across the different height-measurement methods.
Time frame: one day
Time frame: one day
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire, Amiens
Other
Acronym: SIZE-ARDS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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