Clinical Trial

"Lung Barometric Measurements in Normal And in Respiratory Distressed Lungs"

Study acronym: LUNAR
Recruiting
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Record status
This record was last updated March 17, 2025 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
Little is known about how lung mechanics are affected during the very early phase after starting mechanical ventilation. Since the conventional method of measuring esophageal pressure is complicated, hard to interpret and expensive, there are no studies on lung mechanics on intensive care patients directly after intubation, during the first hours of ventilator treatment and forward until the ventilator treatment is withdrawn. Published studies have collected data using the standard methods from day 1 to 3 of ventilator treatment for respiratory system mechanics, i.e. the combined mechanics of lung and chest wall. Consequently, information on lung mechanical properties during the first critical hours of ventilator treatment is missing and individualization of ventilator care done on the basis of respiratory system mechanics, which are not representative of lung mechanics on an individual patient basis. We have developed a PEEP-step method based on a change of PEEP up and down in one or two steps, where the change in end-expiratory lung volume ΔEELV) is determined and lung compliance calculated as ΔEELV divided by ΔPEEP (CL = ΔEELV/ΔPEEP). This simple non-invasive method for separating lung and chest wall mechanics provides an opportunity to enhance the knowledge of lung compliance and the transpulmonary pressure. After the two-PEEP-step procedure, the PEEP level where transpulmonary driving pressure is lowest can be calculated for any chosen tidal volume. The aim of the present study in the ICU is to survey lung mechanics from start of mechanical ventilation until extubation and to determine PEEP level with lowest (least injurious) transpulmonary driving pressure during ventilator treatment. The aim of the study during anesthesia in the OR, is to survey lung mechanics in lung healthy and identify patients with lung conditions before anesthesia, which may have an increased risk of postoperative complications.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-07-20; most recent amendment 2025-03-13.
Status change: Not Yet Recruiting → Recruiting 2022-03-31
Trial Details
NCT Number NCT04484727
Lead Sponsor Göteborg University
Collaborators: Sahlgrenska University Hospital
Conditions Ventilator-Induced Lung Injury, Ventilatory Failure, Ventilator Lung, Ventilation Therapy; Complications, Ventilator Associated Pneumonia
Enrollment 200 participants
Start Date 2022-05-01
Primary Completion 2026-05-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-17