Body Weight Distribution for Acute Respiratory Failure

Overseen By Maurizio F Cereda, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Maurizio F. Cereda, MD

Disqualifiers: Pregnancy, Chronic lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different body weights and fat distributions affect lung function in individuals with acute hypoxemic respiratory failure (AHRF), a condition where lung injuries hinder breathing. Researchers are testing two lung therapies, PEEP (positive end-expiratory pressure) and prone positioning (lying face down), to determine their effectiveness for various body types. Participants will alternate between different air pressures and body positions while researchers monitor lung function. This trial targets adults with AHRF who are currently on mechanical ventilation. Participants should not have serious heart problems or certain lung diseases. As an unphased trial, this study provides a unique opportunity to understand how body types influence lung therapy effectiveness.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these interventions are safe for patients with acute hypoxemic respiratory failure?

Research has shown that using electrical impedance tomography (EIT) to guide positive end-expiratory pressure (PEEP) in patients is both practical and safe. EIT, a non-invasive tool, helps doctors visualize air movement in the lungs. Studies have found that it can reduce lung stress, particularly in those with severe breathing problems, indicating that the treatment is generally well-tolerated.

Prone positioning, which involves lying face down, is a common method to help individuals with lung issues breathe better. Most patients tolerate this position well, and it often enhances lung function.

In summary, both EIT-guided PEEP and prone positioning are considered safe based on current research. They are already used in medical settings and show promising results in improving lung function without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative techniques for managing acute respiratory failure. Traditional treatments typically involve mechanical ventilation with fixed PEEP settings, but this trial uses Electrical Impedance Tomography (EIT) to guide PEEP titration more precisely. By dynamically adjusting PEEP levels and experimenting with body positioning between supine and prone, the trial aims to optimize lung function and improve outcomes. This approach could lead to more personalized and effective respiratory support, potentially transforming how acute respiratory failure is treated.

What evidence suggests that this trial's treatments could be effective for acute hypoxemic respiratory failure?

Research has shown that using electrical impedance tomography (EIT) to adjust breathing support in patients with severe breathing problems can lead to better outcomes. In this trial, participants will undergo ventilatory assessments at two PEEP levels, with EIT guiding the titration of PEEP. One study found that using EIT to guide these adjustments significantly lowered the death rate in patients with severe lung issues, such as acute respiratory distress syndrome (ARDS). EIT allows doctors to see how air moves in the lungs, helping them set the optimal breathing support level for each patient. This personalized method can improve lung function by enhancing airflow and reducing lung stress. Using EIT may provide a safer and more effective way to help patients with lung injuries breathe better. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Acute Hypoxemic Respiratory Failure (AHRF) who have been intubated for less than 72 hours and have a PaO2/FiO2 ratio of ≤300 mmHg. They must also have an arterial line in place for blood gas measurement and blood pressure monitoring.

Inclusion Criteria

I have been on a breathing machine for less than 3 days due to severe lung issues.

Presence of an arterial line for blood gas measurement and blood pressure monitoring

I am 18 years old or older.

Exclusion Criteria

I have a long-term lung condition or high blood pressure in my lungs.

My blood pressure is very low or very high and not stable even with medication.

I have a collapsed lung.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo mechanical ventilation assessments at two PEEP levels and body positions (supine and prone) with EIT and esophageal manometry

1 day

1 visit (in-person)

Data Collection

Collection of arterial blood samples and biomarker analysis during the study procedures

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Body Positioning: Supine and Prone
• PEEP Titration Using Electrical Impedance Tomography (EIT)

Trial Overview The study tests how body weight and fat distribution affect lung response to two treatments: PEEP Titration using Electrical Impedance Tomography (EIT) to map lung ventilation, and changing body positions between supine and prone. It aims to improve oxygen exchange in patients with AHRF.

How Is the Trial Designed?

Group I: Single Arm: Ventilatory Assessment at Two PEEP Levels and Body Positions Experimental Treatment 2 Interventions

A total of 80 patients will undergo sequential assessments during mechanical ventilation at two levels of PEEP: 1. Clinician-set PEEP (PEEP\_CLIN) 2. PEEP determined by EIT-guided titration (PEEP\_TIT) These interventions will be applied first in the supine position, with each PEEP level maintained for approximately 30 minutes. Afterward, patients will be repositioned to the prone position, and the same assessments and EIT-guided PEEP titration will be repeated.

Who Is Running the Clinical Trial?

Maurizio F. Cereda, MD

Lead Sponsor

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. link.springer.com link.springer.com/article/10.1007/s10877-025-01266-2

Electrical impedance tomography for PEEP titration in ... EIT-guided PEEP titration was associated with a significant reduction in mortality among critically ill patients with ARDS.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07175194

Association Between EIT and CT During PEEP Titration in ... This study aims to verify whether the "best" PEEP identified using lung EIT is strongly associated with the net response assessed using lung CT, when PEEP is ...

3. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-024-03394-y

Electrical impedance tomography guided positive end ... This study aims to develop a comprehensive view of the efficacy and long-term prognosis of EIT-guided PEEP compared to other conventional approaches.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0954611121002614

A compass for the safe route to optimal PEEP Electrical impedance tomography (EIT) is a non-invasive bedside tool that monitors in real-time ventilation distribution.

5. annalsofintensivecare.springeropen.com annalsofintensivecare.springeropen.com/articles/10.1186/s13613-019-0484-0

Positive end-expiratory pressure titration with electrical ... The study objective was to compare titration of positive end-expiratory pressure (PEEP) with electrical impedance tomography (EIT) and with ventilator-embedded ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12474599/

Electrical impedance tomography for PEEP titration in ... To assess the efficacy of electrical impedance tomography (EIT)-guided positive end-expiratory pressure (PEEP) titration in improving outcomes ...

7. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-023-04315-x

Electric impedance tomography-guided PEEP titration ... In patients with moderate–severe acute respiratory distress syndrome, EIT-guided PEEP titration reduces mechanical power mainly through a reduction in elastic– ...