NCT04484727 "Lung Barometric Measurements in Normal And in Respiratory Distressed Lungs"
| NCT ID | NCT04484727 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Göteborg University |
| Condition | Ventilator-Induced Lung Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-05-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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directly after intubation, during the first hours of ventilator treatment and forward until the ventilator treatment is withdrawn.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.
Eligibility Criteria
Inclusion Criteria: * Patients above18 years * ASA 1-3 * Planned/acute ventilator treatment in ICU or OR Exclusion Criteria: * Patients under 18 years * ASA 4 and above * severe COPD/emphysema/heart failure * PEEP\>16 and/or FiO2 \>80% * elevated intracranial pressure * defect coagulation * non-treated known or suspected pneumothorax
Contact & Investigator
Bengt Nellgård, Prof
STUDY CHAIR
Sahlgrenska Academy
Frequently Asked Questions
Who can join the NCT04484727 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventilator-Induced Lung Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04484727 currently recruiting?
Yes, NCT04484727 is actively recruiting participants. Contact the research team at sophie.lindgren@vgregion.se for enrollment information.
Where is the NCT04484727 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT04484727 clinical trial?
NCT04484727 is sponsored by Göteborg University. The principal investigator is Bengt Nellgård, Prof at Sahlgrenska Academy. The trial plans to enroll 200 participants.