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RecruitingNCT07595926SIZE-ARDSUpdated Jul 6, 2026

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

An interventional study of height measured in Acute Respiratory Distress Syndrome, Ventilator-Induced Lung Injury and Tidal Volume, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other

From the registry’s dates

  • Started May 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Respiratory Distress Syndrome
  • Ventilator-Induced Lung Injury
  • Tidal Volume
  • Predicted Body Weight
  • Height

Keywords

  • acute respiratory distress syndrome
  • ventilator-induced lung injury
  • tidal volume
  • predicted body weight
  • height
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 39 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (estimated)

Study arms

  • Experimental
    ards patients

    Other: height measured

Interventions

  • Otherheight 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 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.

06

What researchers measure

Primary outcomes

  1. Pulmonary stress

    Pulmonary stress assessed by measuring end-inspiration transpulmonary pressure using a balloon esophageal probe.

    Time frame: one day

Secondary outcomes

  1. measured height variation

    Agreement of measured height across the different height-measurement methods.

    Time frame: one day

  2. predicted body weight variation

    Agreement of predicted body weight across the different height-measurement methods.

    Time frame: one day

  3. tidal volume variation

    Agreement of tidal volume across the different height-measurement methods.

    Time frame: one day

  4. Transpulmonary pressures at end-expiratory

    Time frame: one day

  5. Transpulmonary pressures at end-inspiratory intervals.

    Time frame: one day

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07595926
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
May 19, 2026
Start date
May 20, 2026
Primary completion
May 2028 (estimated)
Completion
May 2028 (estimated)
Last update
Jul 6, 2026

Study contacts

Clément BRAULT, MD
Contact
brault.clement@chu-amiens.fr
33+322087831

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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