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End-expiratory Trans-pulmonary Pressure Guided PEEP Titration in Patients With Pulmonary Fibrosis and UIP Pattern Undergoing Mechanical Ventilation
Study Purpose
Patients with pulmonary fibrosis and associated usual interstitial pneumonia that require mechanical ventilation for acute respiratory failure experience poor clinical outcomes. This may be influenced by the unfavorable interaction between the fibrotic lung and the stress and strain stimuli generated during controlled ventilation. Although there is no consensus on how to ventilate these patients, much of the recommendations followed in clinical practice are taken from the experience on patients with acute respiratory distress syndrome. Among these, measuring the esophageal pressures and adjusting positive-end expiatory pressure to make trans-pulmonary pressures positive can decrease atelectasis, derecruitment of lung, and cyclical opening and closing of airways and alveoli, thus optimizing lung mechanics and oxygenation. The effect of this strategy on the fibrotic lung has not yet been documented. With this observational study we aim at documenting the effect of PEEP titration maneuver based on end-expiratory trans-pulmonary pressure on lung mechanics of patients with pulmonary fibrosis and UIP pattern,
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
| Eligible Ages | 18 Years - 90 Years |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05098717 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
University of Modena and Reggio Emilia |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Recruiting |
| Countries | Italy |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Idiopathic Pulmonary Fibrosis, Mechanical Ventilation Pressure High |
Contact a Trial Team
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