Mechanical VentilationPPLprojectNCT04443491
Comparison of Esophageal and Central Venous Pressure for Estimating Transpulmonary Pressure Changes
An observational study of Mechanical Ventilation and Acute Respiratory Distress Syndrome, run by University of Siena at 1 site in Italy.
Trial summary
Central venous pressure (CVP) is characterized by a low-frequency pleural-dependent as well as a high-frequency cardiac pulsatile component. The aim of the study is to compare the low-frequency component of CVP with the esophageal pressure (Pes), as surrogate of pleural pressure, to estimate trans-pulmonary pressure… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mechanical Ventilation, Acute Respiratory Distress Syndrome
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- May 2016to Mar 2019
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to ICU treated with mechanical ventilation.
Who may be able to join
- adult patients receiving invasive mechanical ventilation
- diagnosis of acute respiratory failure (defined as the ratio of partial oxygen pressure and fraction of inspired oxygen below 200 mmHg)
- esophageal balloon catheter
- central venous catheter
Who cannot join
- age under 18 years old
- Hemodynamic instability
- Esophageal diseases (varices, stenosis..)
- Refusal of the patient
- evidence of active air leak from the lung (pneumothorax, pneumomediastinum, existing chest tube....)
- history of lung/abdominal surgery
- pregnancy
- severe coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimating the Transpulmonary Pressure From the Central Venous Pressure in Mechanically Ventilated Patients With Respiratory Failure
Central venous pressure (CVP) is characterized by a low-frequency pleural-dependent as well as a high-frequency cardiac pulsatile component. The aim of the study is to compare the low-frequency component of CVP with the esophageal pressure (Pes), as surrogate of pleural pressure, to estimate trans-pulmonary pressure (PL).
Read the detailed description
The investigators will enroll mechanically ventilated patients admitted to the intensive care unit with the diagnosis of respiratory failure monitored with a dedicated nasogastric catheter and a central venous catheter for measuring Pes and CVP, respectively. Electrocardiogram trace, Pes, CVP and airway pressure (Paw) will be recorded at the end of inspiratory and expiratory pauses. The CVP waveforms will be analyzed off-line using a dedicated low-pass digital filter to obtain the low-frequency component of CVP (filtered CVP, fCVP). Paw, Pes and fCVP will be used to calculate PL using transpulmonary driving pressure formula (PL-Pes and PL-fCVP, respectively). The PL values obtained with fCVP and Pes will be compared to assess the correlation of the two methods.
- Keywords
- esophageal pressure, transpulmonary pressure, central venous pressure, acute respiratory failure
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Transpulmonary pressure
Correlation and agreement between the transpulmonary pressure obtained from esophageal balloon catheter and central venous catheter
Measured: Within 72 hours from the starting of mechanical ventilation
Secondary outcomes (2)
Transpulmonary pressure in subgroups of patients
Agreement between trans pulmonary pressure obtained with the two methods in subgroup of patients such as those with acute respiratory distress syndrome or obesity
Measured: Within 72 hours from the starting of mechanical ventilation
Transpulmonary pressure in patients at risk for ventilator-induced-lung-injury
Comparison of the transpulmonary pressure obtained with the two methods in patients at risk for ventilator-induced-lung-injury
Measured: Within 72 hours from the starting of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study startMay 2016
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Franchi, University of Siena
- Investigators
- Federico Franchi, MD, Principal investigator, University of Siena, Depatment of Medical Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443491
- Sponsor's protocol ID
- PPL project
- Acronym
- PPLproject
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating the Transpulmonary Pressure From the Central Venous Pressure in Mechanically Ventilated Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT04443491
- Acronym / sponsor ID
- PPLproject / PPL project
- Keywords
- esophageal pressure, transpulmonary pressure, central venous pressure, acute respiratory failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 23 Jun 2020 (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.
Central venous pressure (CVP) is characterized by a low-frequency pleural-dependent as well as a high-frequency cardiac pulsatile component. The aim of the study is to compare the low-frequency component of CVP with the esophageal pressure (Pes), as surrogate of pleural pressure, to estimate trans-pulmonary pressure (PL).
Detailed description
The investigators will enroll mechanically ventilated patients admitted to the intensive care unit with the diagnosis of respiratory failure monitored with a dedicated nasogastric catheter and a central venous catheter for measuring Pes and CVP, respectively. Electrocardiogram trace, Pes, CVP and airway pressure (Paw) will be recorded at the end of inspiratory and expiratory pauses. The CVP waveforms will be analyzed off-line using a dedicated low-pass digital filter to obtain the low-frequency component of CVP (filtered CVP, fCVP). Paw, Pes and fCVP will be used to calculate PL using transpulmonary driving pressure formula (PL-Pes and PL-fCVP, respectively). The PL values obtained with fCVP and Pes will be compared to assess the correlation of the two methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to ICU treated with mechanical ventilation.
Key inclusion criteria (4 listed)
- adult patients receiving invasive mechanical ventilation
- diagnosis of acute respiratory failure (defined as the ratio of partial oxygen pressure and fraction of inspired oxygen below 200 mmHg)
- esophageal balloon catheter
- central venous catheter
Key exclusion criteria (8 listed)
- age under 18 years old
- Hemodynamic instability
- Esophageal diseases (varices, stenosis..)
- Refusal of the patient
- evidence of active air leak from the lung (pneumothorax, pneumomediastinum, existing chest tube....)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transpulmonary pressure
Time frame: Within 72 hours from the starting of mechanical ventilation
Correlation and agreement between the transpulmonary pressure obtained from esophageal balloon catheter and central venous catheter
2 secondary outcomes
Transpulmonary pressure in subgroups of patients
Time frame: Within 72 hours from the starting of mechanical ventilation
Transpulmonary pressure in patients at risk for ventilator-induced-lung-injury
Time frame: Within 72 hours from the starting of mechanical ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- 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. This study is not recruiting at the moment.
Federico Franchi, MD principal investigator
University of Siena, Depatment of Medical Biotechnology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Acute Respiratory Distress Syndrome, run by University of Siena 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 23 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transpulmonary pressure (time frame: Within 72 hours from the starting of mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2020.