Height Measurement Procedures Influence the Risk of Ventilator-induced Lung Injury in ARDS
SIZE-ARDS
1 other identifier
interventional
39
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedFirst Posted
Study publicly available on registry
May 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
May 19, 2026
April 1, 2026
2 years
April 28, 2026
May 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pulmonary stress
Pulmonary stress assessed by measuring end-inspiration transpulmonary pressure using a balloon esophageal probe.
one day
Secondary Outcomes (5)
measured height variation
one day
predicted body weight variation
one day
tidal volume variation
one day
Transpulmonary pressures at end-expiratory
one day
Transpulmonary pressures at end-inspiratory intervals.
one day
Study Arms (1)
ards patients
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Adult patient
- Mechanical ventilation on volumetric mode
- Sedated and curarized patient
- Diagnosis of ARDS according to the Berlin criteria
- Diagnosis of ARDS \< 48 hours
- Signed informed consent
- Affiliation with a social security or health insurance scheme
You may not qualify if:
- Patient opposing the use of his/her data for research purposes.
- Contraindication to placement of an esophageal balloon catheter (e.g., esophageal fistula, esophageal varices).
- Contraindication to strict supine positioning for height measurement (e.g., proven or suspected intracranial hypertension with intracranial pressure \>18 mmHg).
- Impossibility of measuring height with the reference method (stadiometer) due to deformity or amputation of both lower limbs.
- Patient under guardianship or curatorship, or deprived of liberty.
- Pregnant or postpartum patient, or patient currently breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, 80480, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2026
First Posted
May 19, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
May 19, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share