Respiratory FailureLOVE BEERNCT06174636
Lung Overdistension and Abdominal Pressure Rise
A study testing Application of abdominal weight in people with Respiratory Failure and Respiratory Distress Syndrome, Adult, run by University of Padova at 1 site in Italy.
Trial summary
The goal of this pilot interventional no-profit study is to evaluate airway pressure, esophageal pressure and variations in lung volume distribution with EIT in mechanically ventilated patients admitted to our UTI with respiratory failure after the application of an abdominal weight and resulting increase of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Respiratory Distress Syndrome, Adult
- What is being tested?
- Application of abdominal weight
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jun 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasive mechanical ventilation in acute respiratory failure (PaO2/FiO2 <300 mmHg)
- Need of PEEP trial
- Need of urinary catheter (used to measure IAP)
Who cannot join
- Contraindication to EIT use
- Pacemaker or other metal device in thoracic region
- Contraindication to abdominal weight placement
- Surgical or traumatic incision on the abdomen
- Severe abdominal hypertension
- Esophageal diseases that counterindicate naso-gastric tube placement
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- Severe hemodynamic instability (norepinephrine > 0.1 mcg/kg/min; dobutamine or dopamine > 5 mcg/kg/min; epinephrine every dosage)
- Severe obesity (BMI > 35 kg/m2)
- Need of > 7 kg weight to reach 5 mmHg IAP increase
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Università di Padova
Padova, 35100
Paolo Persona, MD, 00390498212222, ppersona75@gmail.com
About this study
Official title: Lung Overdistension and Abdominal Pressure Rise: an EIT Based Pilot Study
The goal of this pilot interventional no-profit study is to evaluate airway pressure, esophageal pressure and variations in lung volume distribution with EIT in mechanically ventilated patients admitted to our UTI with respiratory failure after the application of an abdominal weight and resulting increase of intra-abdominal pressure.
- Being tested
- Application of abdominal weight
- Keywords
- Abdominal pressure, Overdistension
- Medical subject headings
- Respiratory Insufficiency, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of abdominal weightProcedure or surgery
Also called Intra abdominal pressure rise
Application of variable weight on the abdomen to reach a 5 mmHg increase in IAP
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Pressure Rise | Experimental | Application of an abdominal weight and record of respiratory mechanics data, intra-abdominal pressure variation, Electrical Impedance Tomography data Receives: Procedure: Application of abdominal weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of lung volume distribution
TID %
Measured: through study completion, an average of 1 year
Variation of airway pressure
cmH2O
Measured: through study completion, an average of 1 year
Variation of esophageal pressure
cmH2O
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start20 Jun 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Persona, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174636
- Sponsor's protocol ID
- AOP2978
- Acronym
- LOVE BEER
- Status last verified
- Dec 2023
- First submitted
- 9 Jul 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pacchiarini G, Pettenuzzo T, Zarantonello F, Sella N, Lumetti G, Boscolo A, De Cassai A, Cammarota G, Persona P, Navalesi P; LOVE BEER Study Group. The "mechanical paradox" unveiled: a physiological study. Crit Care. 2025 May 16;29(1):194. doi: 10.1186/s13054-025-05385-9.
PubMed 40380228
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Overdistension and Abdominal Pressure Rise: an EIT Based Pilot Study
- ClinicalTrials.gov ID
- NCT06174636
- Acronym / sponsor ID
- LOVE BEER / AOP2978
- Keywords
- Abdominal pressure, Overdistension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Dec 2023 (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.
The goal of this pilot interventional no-profit study is to evaluate airway pressure, esophageal pressure and variations in lung volume distribution with EIT in mechanically ventilated patients admitted to our UTI with respiratory failure after the application of an abdominal weight and resulting increase of intra-abdominal pressure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal Pressure Rise | Experimental | Procedure: Application of abdominal weightApplication of an abdominal weight and record of respiratory mechanics data, intra-abdominal pressure variation, Electrical Impedance Tomography data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Invasive mechanical ventilation in acute respiratory failure (PaO2/FiO2 <300 mmHg)
- Need of PEEP trial
- Need of urinary catheter (used to measure IAP)
Key exclusion criteria (9 listed)
- Contraindication to EIT use
- Pacemaker or other metal device in thoracic region
- Contraindication to abdominal weight placement
- Surgical or traumatic incision on the abdomen
- Severe abdominal hypertension
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 |
|---|---|---|
| Application of abdominal weightAlso: Intra abdominal pressure riseApplication of variable weight on the abdomen to reach a 5 mmHg increase in IAP | Procedure or surgery | Abdominal Pressure Rise |
Primary outcome
Variation of lung volume distribution
Time frame: through study completion, an average of 1 year
TID %
Variation of airway pressure
Time frame: through study completion, an average of 1 year
cmH2O
Variation of esophageal pressure
Time frame: through study completion, an average of 1 year
cmH2O
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 40380228Pacchiarini G, Pettenuzzo T, Zarantonello F, Sella N, Lumetti G, Boscolo A, De Cassai A, Cammarota G, Persona P, Navalesi P; LOVE BEER Study Group. The "mechanical paradox" unveiled: a physiological study. Crit Care. 2025 May 16;29(1):194. doi: 10.1186/s13054-025-05385-9.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of abdominal weight in people with Respiratory Failure and Respiratory Distress Syndrome, Adult, run by University of Padova at 1 site in Italy.
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 9 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: status not confirmed, as of the sponsor's last update on 18 Dec 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Persona, MD, PhD (+39 3389745902, ppersona75@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of lung volume distribution (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 NCT06174636, which also lists 1 linked publication.
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 18 Dec 2023.