- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07595926
Height Measurement Procedures Influence the Risk of Ventilator-induced Lung Injury in ARDS (SIZE-ARDS)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clement Brault, MD
- Phone Number: 33+322087831
- Email: brault.clement@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80480
- CHU Amiens
-
Contact:
- Clement Brault, MD
- Phone Number: 33+322087831
- Email: brault.clement@chu-amiens.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ards patients
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulmonary stress
Time Frame: one day
|
Pulmonary stress assessed by measuring end-inspiration transpulmonary pressure using a balloon esophageal probe.
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
measured height variation
Time Frame: one day
|
Agreement of measured height across the different height-measurement methods.
|
one day
|
|
predicted body weight variation
Time Frame: one day
|
Agreement of predicted body weight across the different height-measurement methods.
|
one day
|
|
tidal volume variation
Time Frame: one day
|
Agreement of tidal volume across the different height-measurement methods.
|
one day
|
|
Transpulmonary pressures at end-expiratory
Time Frame: one day
|
one day
|
|
|
Transpulmonary pressures at end-inspiratory intervals.
Time Frame: one day
|
one day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2026_843_0061
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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