Acute Hypoxemic Respiratory FailureNCT07019987
Adiposity Distribution in Acute Respiratory Failure
A study testing PEEP Titration Using Electrical Impedance Tomography (EIT) and Body Positioning: Supine and Prone in people with Acute Hypoxemic Respiratory Failure and Obesity, run by Maurizio F. Cereda, MD at 1 site in United States.
Trial summary
Acute Hypoxemic Respiratory Failure (AHRF) is a condition in which injury to the lungs impairs the ability of the air sacs (alveoli) to ventilate and exchange oxygen. This impairment may be worsened in individuals with elevated body weight, particularly when fat tissue compresses the lungs and promotes alveolar… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure, Obesity
- What is being tested?
- PEEP Titration Using Electrical Impedance Tomography (EIT) and Body Positioning: Supine and Prone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2028to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHRF with PaO2/FiO2 <= 300 mmHg) intubated for less than 72 hours
- Presence of an arterial line for blood gas measurement and blood pressure monitoring
- 18 years or older
Who cannot join
- Suspected pregnancy, pregnancy or less than six weeks postpartum
- Younger than 18 years or older than 80 years.
- Subject enrolled in another interventional research study
- Presence of pneumothorax
- Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator
- Preexisting chronic lung disease or pulmonary hypertension
Show all 13Show fewer
- Acute cardiac failure causing pulmonary edema
- Past medical history of lung malignancy or pneumonectomy, or lung transplant
- Hemodynamic instability, defined as:
- Persistent systolic blood pressure <90 mmHg and/or >180 mmHg despite the use of vasopressor or vasodilators, or
- Requiring an increment in inotropic-vasopressors over the past two hours just before enrollment: more than 15 mcg/min for norepinephrine and dopamine, more than 10 mcg/min in epinephrine; and more than 50 mcg/ min for phenylephrine.
- Contraindications to placement in the prone position: complex abdominal surgical dressing, recent sternotomy, unstable spine or pelvic fractures, intracranial hypertension, serious facial injury
- Extracorporeal life support
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Maurizio F Cereda, MD, 6176430987, mcereda@mgh.harvard.edu
Lorenzo Berra, MD, 617 724 0743, lberra@mgh.harvard.edu
About this study
Official title: Imaging the Respiratory Effects of Truncal Adiposity in Acute Hypoxemic Respiratory Failure
Acute Hypoxemic Respiratory Failure (AHRF) is a condition in which injury to the lungs impairs the ability of the air sacs (alveoli) to ventilate and exchange oxygen. This impairment may be worsened in individuals with elevated body weight, particularly when fat tissue compresses the lungs and promotes alveolar collapse. The impact of body weight on lung function may be greater in individuals with upper-body fat distribution.
Two common interventions for AHRF-positive end-expiratory pressure (PEEP) and prone positioning-are used to improve lung ventilation. However, it is unclear whether these therapies are equally effective across different body weight categories and fat distributions.
Read more
This study will evaluate whether body weight and fat distribution affect patients' lung inflation responses to PEEP and prone positioning. Lung inflation will be assessed using electrical impedance tomography (EIT), a bedside imaging tool that maps lung ventilation, and esophageal manometry, which estimates lung compression through a thin catheter placed in the esophagus. Laboratory tests will also be used to measure markers of inflammation and AHRF severity and find correlations with fat distribution and responses to the tested treatments..
Patients with AHRF requiring mechanical ventilation will be enrolled across a range of body weights. Each participant will undergo combinations of two PEEP levels and two body positions (supine and prone) for 30 minutes each. At the end of the study procedures, clinical care will continue as determined by the treating team.
Read the detailed description
This study investigates the relationship between body habitus and the physiological response to ventilatory interventions in patients with Acute Hypoxemic Respiratory Failure (AHRF). The primary objectives are to determine:
- Whether excess body weight affects the regional lung inflation response to PEEP and prone positioning;
- Whether body fat distribution (e.g., central vs. peripheral) is associated with lung recruitment;
- Whether inflation responses correlate with laboratory markers of systemic inflammation and AHRF severity.
Adult patients with AHRF requiring invasive mechanical ventilation will be screened daily in the intensive care units at Massachusetts General Hospital. The study team will coordinate with clinical staff and patient surrogates to obtain informed consent. Enrollment is limited to the period required to perform study-specific procedures. No follow-up visits or post-discharge interventions are planned.
After consent, participants will be equipped with two adhesive EIT electrode belts, placed bilaterally on the thorax, to measure regional ventilation. A pressure and flow sensor will be placed in the breathing circuit at the proximal end of the endotracheal tube. An esophageal balloon catheter will be inserted nasally into the distal esophagus (approximately 35-40 cm) to measure intrathoracic pressure (ITP) via esophageal manometry, recorded through an auxiliary module on the EIT device.
Once all monitoring devices are in place, patients will be evaluated for adequate sedation and ventilator synchrony. Baseline data will be recorded during ventilation at the clinician-selected PEEP level (PEEP_CLIN), including EIT, airway pressure, flow, and ITP signals over 20 consecutive breaths.
Subsequently, a PEEP titration trial will be conducted to identify an individualized PEEP value (PEEP_TIT) that minimizes both alveolar collapse and overdistension, using EIT-based criteria. The patient will then be ventilated at PEEP_TIT for 30 minutes, after which all measurements will be repeated.
Following supine data collection, patients will be transitioned to the prone position using standard clinical protocols, with participation from ICU staff (physicians, nurses, and respiratory therapists) in accordance with institutional practice. Continuous monitoring (including pulse oximetry and arterial blood pressure) will be maintained throughout the repositioning.
After achieving the prone position, a recruitment maneuver will be performed to standardize lung volume history. The EIT belts will then be reconnected, and the patient will be allowed to stabilize for 30 minutes at PEEP_CLIN before measurements are repeated. A second PEEP titration trial will be performed to determine PEEP_TIT in the prone position, followed by another 30-minute stabilization period and repeat data acquisition.
Arterial blood samples (2 mL each) will be obtained at each PEEP level in both positions (four total, 8 mL cumulative) for gas exchange analysis. An additional 10 mL sample will be collected during supine ventilation at PEEP_CLIN for biomarker analysis. Biomarkers of inflammation (e.g., IL-6, TNF-α, C-reactive protein) and adipose tissue-related factors (e.g., adiponectin, leptin, resistin) will be measured.
After study procedures, participants will be returned to the supine position unless otherwise indicated by the clinical team. All subsequent clinical decisions regarding ventilator management or patient positioning will be made by the attending care team.
This study seeks to generate mechanistic insights into how excess body weight and fat distribution affect the physiologic response to standard ventilatory interventions in AHRF, with the goal of informing more individualized approaches to respiratory support.
- Conditions
- Acute Hypoxemic Respiratory Failure, Obesity
- Being tested
- PEEP Titration Using Electrical Impedance Tomography (EIT), Body Positioning: Supine and Prone
- Keywords
- acute hypoxemic respiratory failure, obesity, electrical impedance tomography, esophageal manometry, mechanical ventilation, prone positioning, positive end expiratory pressure
- Medical subject headings
- Respiratory Insufficiency, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP Titration Using Electrical Impedance Tomography (EIT)Other
EIT will be used to guide individualized PEEP titration in mechanically ventilated patients with AHRF. Each subject will receive mechanical ventilation at two PEEP levels:
PEEP_CLIN (set by the treating clinician)
PEEP_TIT (identified using EIT to minimize alveolar collapse and overdistension)
Both levels will be maintained for 30 minutes in each body position, with continuous physiologic data collected during each phase.
Body Positioning: Supine and ProneProcedure or surgery
Each subject will be ventilated in both the supine and prone positions. Positioning will follow institutional protocols and be coordinated with clinical staff to ensure safety. After supine assessments are completed, the patient will be transitioned to prone, followed by a recruitment maneuver to standardize lung volume history. The PEEP titration protocol will then be repeated in the prone position.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: Ventilatory Assessment at Two PEEP Levels and Body Positions | Experimental | 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. Receives: Other: PEEP Titration Using Electrical Impedance Tomography (EIT); Procedure: Body Positioning: Supine and Prone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving pressure with PEEP titration and prone position
The primary outcome will be the difference in driving pressure (inspiratory plateau pressure minus total PEEP, in cmH2O) in response to PEEP titration strategies and to prone position. Changes in driving pressure will be correlated with body mass index, and with measurements of thoracic, and abdominal circumference.
Measured: Day 1, after 30 minutes in each combination of PEEP and body position
Secondary outcomes (1)
Regional ventilation
Changes in EIT-derived measurements of regional ventilation with PEEP titration and prone positioning. EIT regional ventilation is measured as percentage of total ventilation in each examined lung region.
Measured: Day 1, after 30 minutes in each combination of PEEP and body position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Jan 2028 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In a prospective, single-center, physiological, crossover study, the investigators will recruit 80 mechanically ventilated adults with acute hypoxemic respiratory failure, across four standard body mass index categories (normal weight, overweight, class I obesity, class II/III obesity) and sex.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maurizio F. Cereda, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Maurizio F. Cereda, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019987
- Sponsor's protocol ID
- 2025P001410
- Status last verified
- Jun 2025
- First submitted
- 20 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hao D, Low S, Di Fenza R, Shenoy ES, Ananian L, Prout LA, La Vita CJ, Berra L. Prone Positioning of Intubated Patients with an Elevated Body-Mass Index. N Engl J Med. 2022 Apr 7;386(14):e34. doi: 10.1056/NEJMvcm2108494. No abstract available.
PubMed 35388669Kompaniyets L, Goodman AB, Belay B, Freedman DS, Sucosky MS, Lange SJ, Gundlapalli AV, Boehmer TK, Blanck HM. Body Mass Index and Risk for COVID-19-Related Hospitalization, Intensive Care Unit Admission, Invasive Mechanical Ventilation, and Death - United States, March-December 2020. MMWR Morb Mortal Wkly Rep. 2021 Mar 12;70(10):355-361. doi: 10.15585/mmwr.mm7010e4.
PubMed 33705371Behazin N, Jones SB, Cohen RI, Loring SH. Respiratory restriction and elevated pleural and esophageal pressures in morbid obesity. J Appl Physiol (1985). 2010 Jan;108(1):212-8. doi: 10.1152/japplphysiol.91356.2008. Epub 2009 Nov 12.
PubMed 19910329De Santis Santiago R, Teggia Droghi M, Fumagalli J, Marrazzo F, Florio G, Grassi LG, Gomes S, Morais CCA, Ramos OPS, Bottiroli M, Pinciroli R, Imber DA, Bagchi A, Shelton K, Sonny A, Bittner EA, Amato MBP, Kacmarek RM, Berra L; Lung Rescue Team Investigators. High Pleural Pressure Prevents Alveolar Overdistension and Hemodynamic Collapse in Acute Respiratory Distress Syndrome with Class III Obesity. A Clinical Trial. Am J Respir Crit Care Med. 2021 Mar 1;203(5):575-584. doi: 10.1164/rccm.201909-1687OC.
PubMed 32876469Florio G, De Santis Santiago RR, Fumagalli J, Imber DA, Marrazzo F, Sonny A, Bagchi A, Fitch AK, Anekwe CV, Amato MBP, Arora P, Kacmarek RM, Berra L. Pleural Pressure Targeted Positive Airway Pressure Improves Cardiopulmonary Function in Spontaneously Breathing Patients With Obesity. Chest. 2021 Jun;159(6):2373-2383. doi: 10.1016/j.chest.2021.01.055. Epub 2021 May 8.
PubMed 34099131Spina S, Mantz L, Xin Y, Moscho DC, Ribeiro De Santis Santiago R, Grassi L, Nova A, Gerard SE, Bittner EA, Fintelmann FJ, Berra L, Cereda M. The pleural gradient does not reflect the superimposed pressure in patients with class III obesity. Crit Care. 2024 Sep 16;28(1):306. doi: 10.1186/s13054-024-05097-6.
PubMed 39285477
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging the Respiratory Effects of Truncal Adiposity in Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT07019987
- Acronym / sponsor ID
- 2025P001410
- Conditions
- Acute Hypoxemic Respiratory Failure, Obesity
- Keywords
- acute hypoxemic respiratory failure, obesity, electrical impedance tomography, esophageal manometry, mechanical ventilation, prone positioning, positive end expiratory pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maurizio F. Cereda, MDUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Jan 2028 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute Hypoxemic Respiratory Failure (AHRF) is a condition in which injury to the lungs impairs the ability of the air sacs (alveoli) to ventilate and exchange oxygen. This impairment may be worsened in individuals with elevated body weight, particularly when fat tissue compresses the lungs and promotes alveolar collapse. The impact of body weight on lung function may be greater in individuals with upper-body fat distribution.
Two common interventions for AHRF-positive end-expiratory pressure (PEEP) and prone positioning-are used to improve lung ventilation. However, it is unclear whether these therapies are equally effective across different body weight categories and fat distributions.
This study will evaluate whether body weight and fat distribution affect patients' lung inflation responses to PEEP and prone positioning. Lung inflation will be assessed using electrical impedance tomography (EIT), a bedside imaging tool that maps lung ventilation, and esophageal manometry, which estimates lung compression through a thin catheter placed in the esophagus. Laboratory tests will also be used to measure markers of inflammation and AHRF severity and find correlations with fat distribution and responses to the tested treatments..
Patients with AHRF requiring mechanical ventilation will be enrolled across a range of body weights. Each participant will undergo combinations of two PEEP levels and two body positions (supine and prone) for 30 minutes each. At the end of the study procedures, clinical care will continue as determined by the treating team.
Detailed description
This study investigates the relationship between body habitus and the physiological response to ventilatory interventions in patients with Acute Hypoxemic Respiratory Failure (AHRF). The primary objectives are to determine:
- Whether excess body weight affects the regional lung inflation response to PEEP and prone positioning;
- Whether body fat distribution (e.g., central vs. peripheral) is associated with lung recruitment;
- Whether inflation responses correlate with laboratory markers of systemic inflammation and AHRF severity.
Adult patients with AHRF requiring invasive mechanical ventilation will be screened daily in the intensive care units at Massachusetts General Hospital. The study team will coordinate with clinical staff and patient surrogates to obtain informed consent. Enrollment is limited to the period required to perform study-specific procedures. No follow-up visits or post-discharge interventions are planned.
After consent, participants will be equipped with two adhesive EIT electrode belts, placed bilaterally on the thorax, to measure regional ventilation. A pressure and flow sensor will be placed in the breathing circuit at the proximal end of the endotracheal tube. An esophageal balloon catheter will be inserted nasally into the distal esophagus (approximately 35-40 cm) to measure intrathoracic pressure (ITP) via esophageal manometry, recorded through an auxiliary module on the EIT device.
Once all monitoring devices are in place, patients will be evaluated for adequate sedation and ventilator synchrony. Baseline data will be recorded during ventilation at the clinician-selected PEEP level (PEEP_CLIN), including EIT, airway pressure, flow, and ITP signals over 20 consecutive breaths.
Subsequently, a PEEP titration trial will be conducted to identify an individualized PEEP value (PEEP_TIT) that minimizes both alveolar collapse and overdistension, using EIT-based criteria. The patient will then be ventilated at PEEP_TIT for 30 minutes, after which all measurements will be repeated.
Following supine data collection, patients will be transitioned to the prone position using standard clinical protocols, with participation from ICU staff (physicians, nurses, and respiratory therapists) in accordance with institutional practice. Continuous monitoring (including pulse oximetry and arterial blood pressure) will be maintained throughout the repositioning.
After achieving the prone position, a recruitment maneuver will be performed to standardize lung volume history. The EIT belts will then be reconnected, and the patient will be allowed to stabilize for 30 minutes at PEEP_CLIN before measurements are repeated. A second PEEP titration trial will be performed to determine PEEP_TIT in the prone position, followed by another 30-minute stabilization period and repeat data acquisition.
Arterial blood samples (2 mL each) will be obtained at each PEEP level in both positions (four total, 8 mL cumulative) for gas exchange analysis. An additional 10 mL sample will be collected during supine ventilation at PEEP_CLIN for biomarker analysis. Biomarkers of inflammation (e.g., IL-6, TNF-α, C-reactive protein) and adipose tissue-related factors (e.g., adiponectin, leptin, resistin) will be measured.
After study procedures, participants will be returned to the supine position unless otherwise indicated by the clinical team. All subsequent clinical decisions regarding ventilator management or patient positioning will be made by the attending care team.
This study seeks to generate mechanistic insights into how excess body weight and fat distribution affect the physiologic response to standard ventilatory interventions in AHRF, with the goal of informing more individualized approaches to respiratory support.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In a prospective, single-center, physiological, crossover study, the investigators will recruit 80 mechanically ventilated adults with acute hypoxemic respiratory failure, across four standard body mass index categories (normal weight, overweight, class I obesity, class II/III obesity) and sex.
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Ventilatory Assessment at Two PEEP Levels and Body Positions | Experimental | Other: PEEP Titration Using Electrical Impedance Tomography (EIT), Procedure: Body Positioning: Supine and ProneA 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 may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AHRF with PaO2/FiO2 <= 300 mmHg) intubated for less than 72 hours
- Presence of an arterial line for blood gas measurement and blood pressure monitoring
- 18 years or older
Key exclusion criteria (13 listed)
- Suspected pregnancy, pregnancy or less than six weeks postpartum
- Younger than 18 years or older than 80 years.
- Subject enrolled in another interventional research study
- Presence of pneumothorax
- Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP Titration Using Electrical Impedance Tomography (EIT)EIT will be used to guide individualized PEEP titration in mechanically ventilated patients with AHRF. Each subject will receive mechanical ventilation at two PEEP levels: PEEP_CLIN (set by the treating clinician) PEEP_TIT (identified using EIT to minimize alveolar collapse and overdistension) Both levels will be maintained for 30 minutes in each body position, with continuous physiologic data collected during each phase. | Other | Single Arm: Ventilatory Assessment at Two PEEP Levels and Body Positions |
| Body Positioning: Supine and ProneEach subject will be ventilated in both the supine and prone positions. Positioning will follow institutional protocols and be coordinated with clinical staff to ensure safety. After supine assessments are completed, the patient will be transitioned to prone, followed by a recruitment maneuver to standardize lung volume history. The PEEP titration protocol will then be repeated in the prone position. | Procedure or surgery | Single Arm: Ventilatory Assessment at Two PEEP Levels and Body Positions |
Primary outcome
Driving pressure with PEEP titration and prone position
Time frame: Day 1, after 30 minutes in each combination of PEEP and body position
The primary outcome will be the difference in driving pressure (inspiratory plateau pressure minus total PEEP, in cmH2O) in response to PEEP titration strategies and to prone position. Changes in driving pressure will be correlated with body mass index, and with measurements of thoracic, and abdominal circumference.
1 secondary outcome
Regional ventilation
Time frame: Day 1, after 30 minutes in each combination of PEEP and body position
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Background: PubMed 35388669Hao D, Low S, Di Fenza R, Shenoy ES, Ananian L, Prout LA, La Vita CJ, Berra L. Prone Positioning of Intubated Patients with an Elevated Body-Mass Index. N Engl J Med. 2022 Apr 7;386(14):e34. doi: 10.1056/NEJMvcm2108494. No abstract available.
- Background: PubMed 33705371Kompaniyets L, Goodman AB, Belay B, Freedman DS, Sucosky MS, Lange SJ, Gundlapalli AV, Boehmer TK, Blanck HM. Body Mass Index and Risk for COVID-19-Related Hospitalization, Intensive Care Unit Admission, Invasive Mechanical Ventilation, and Death - United States, March-December 2020. MMWR Morb Mortal Wkly Rep. 2021 Mar 12;70(10):355-361. doi: 10.15585/mmwr.mm7010e4.
- Background: PubMed 19910329Behazin N, Jones SB, Cohen RI, Loring SH. Respiratory restriction and elevated pleural and esophageal pressures in morbid obesity. J Appl Physiol (1985). 2010 Jan;108(1):212-8. doi: 10.1152/japplphysiol.91356.2008. Epub 2009 Nov 12.
- Background: PubMed 32876469De Santis Santiago R, Teggia Droghi M, Fumagalli J, Marrazzo F, Florio G, Grassi LG, Gomes S, Morais CCA, Ramos OPS, Bottiroli M, Pinciroli R, Imber DA, Bagchi A, Shelton K, Sonny A, Bittner EA, Amato MBP, Kacmarek RM, Berra L; Lung Rescue Team Investigators. High Pleural Pressure Prevents Alveolar Overdistension and Hemodynamic Collapse in Acute Respiratory Distress Syndrome with Class III Obesity. A Clinical Trial. Am J Respir Crit Care Med. 2021 Mar 1;203(5):575-584. doi: 10.1164/rccm.201909-1687OC.
- Background: PubMed 34099131Florio G, De Santis Santiago RR, Fumagalli J, Imber DA, Marrazzo F, Sonny A, Bagchi A, Fitch AK, Anekwe CV, Amato MBP, Arora P, Kacmarek RM, Berra L. Pleural Pressure Targeted Positive Airway Pressure Improves Cardiopulmonary Function in Spontaneously Breathing Patients With Obesity. Chest. 2021 Jun;159(6):2373-2383. doi: 10.1016/j.chest.2021.01.055. Epub 2021 May 8.
- Background: PubMed 39285477Spina S, Mantz L, Xin Y, Moscho DC, Ribeiro De Santis Santiago R, Grassi L, Nova A, Gerard SE, Bittner EA, Fintelmann FJ, Berra L, Cereda M. The pleural gradient does not reflect the superimposed pressure in patients with class III obesity. Crit Care. 2024 Sep 16;28(1):306. doi: 10.1186/s13054-024-05097-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP Titration Using Electrical Impedance Tomography (EIT) and Body Positioning: Supine and Prone in people with Acute Hypoxemic Respiratory Failure and Obesity, run by Maurizio F. Cereda, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maurizio F Cereda, MD (16176430987, mcereda@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving pressure with PEEP titration and prone position (time frame: Day 1, after 30 minutes in each combination of PEEP and body position). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07019987, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.