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Recruiting NCT07595926

Height Measurement Procedures Influence the Risk of Ventilator-induced Lung Injury in ARDS

No phase Interventional Acute Respiratory Distress Syndrome Ventilator-Induced Lung Injury Tidal Volume Predicted Body Weight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: height measured.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome, Ventilator-Induced Lung Injury, Tidal Volume, Predicted Body Weight. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other height measured
    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 d

Primary outcome measures

  • Pulmonary stress [Time frame: one day]
Secondary outcome measures (5)
  • measured height variation [Time frame: one day]
  • predicted body weight variation [Time frame: one day]
  • tidal volume variation [Time frame: one day]
  • Transpulmonary pressures at end-expiratory [Time frame: one day]
  • Transpulmonary pressures at end-inspiratory intervals. [Time frame: one day]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU Amiens — Amiens

Identifiers

NCT: NCT07595926 · PI2026_843_0061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗