NCT07595926

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

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress3%
May 2026May 2028

First Submitted

Initial submission to the registry

April 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

May 19, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 28, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

acute respiratory distress syndromeventilator-induced lung injurytidal volumepredicted body weightheight

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

EXPERIMENTAL
Other: height measured

Interventions

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.

ards patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Respiratory Distress SyndromeVentilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersLung Injury

Central Study Contacts

Clément BRAULT, MD

CONTACT

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

Locations