Acute Lung InjuryNCT00127491
Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury
A study testing Placement of an esophageal balloon measurements, Low tidal volume ventilation and Transpulmonary pressure-directed ventilation (EPVent) in people with Acute Lung Injury and Acute Respiratory Distress Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to see whether esophageal pressure (PES) measurements will allow the investigators to choose the best method of mechanical ventilation in patients with acute lung injury (ALI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury, Acute Respiratory Distress Syndrome
- What is being tested?
- Placement of an esophageal balloon measurements, Low tidal volume ventilation and Transpulmonary pressure-directed ventilation (EPVent)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to May 2010
- 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
- Patients with ALI/ARDS according to the International Consensus Conference criteria:
- PaO2/FiO2 ratio < 300
- Acute onset
- Bilateral infiltrates on chest radiography
- PAOP < 18 or, in patients without a pulmonary artery catheter, no other evidence of abnormal cardiac function
Who cannot join
- Patients with esophageal varices
- Patients with esophageal trauma
- Patients with recent esophageal surgery
- Patients with coagulopathy (platelets < 80k or International Normalized Ratio [INR]> 2 )
- Post transplant patients
- Patients with significant broncho-pleural fistula
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A RCT of Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury
The purpose of this study is to see whether esophageal pressure (PES) measurements will allow the investigators to choose the best method of mechanical ventilation in patients with acute lung injury (ALI).
Read the detailed description
The current standard of practice for ventilating patients with acute respiratory distress syndrome (ARDS) is the ARDSnet protocol (N Engl J Med 2000; 342:1301-1308) which has been shown to improve survival by limiting tidal volumes and thus preventing over distention of the lungs. However, the lungs can also be damaged by under-inflation during mechanical ventilation, and current practice ignores the effects of chest wall compression of the lungs, which can cause under-inflation. The investigators have observed that a fraction of critically ill patients with apparent ARDS have lung function abnormalities caused by extrinsic compression which can be estimated by PES measurements. Changing ventilator settings to apply normal physiological pressure to the lung has been beneficial in many such patients. This protocol will formally test the clinical utility of PES measurements in patients with ARDS.
This is a randomized controlled trial of therapy directed by esophageal balloon measurements (PES) versus therapy directed by ARDSnet protocol, the current standard of care.
- Being tested
- Placement of an esophageal balloon measurements, Low tidal volume ventilation, Transpulmonary pressure-directed ventilation (EPVent)
- Keywords
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Mechanical Ventilation, Esophageal Pressures, Randomized Controlled Trial
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of an esophageal balloon measurementsProcedure or surgery
In both groups an esophageal balloon will be placed and baseline measurements recorded. In the EP group the mechanical ventilation settings will be determined based on these measurements. In the control group measurements will be recorded but ventilation will be based in the existing standard of care wich is the ARDSnet low tidal volume ventilation study. measurements will be repeated at 24, 48 and 72 hours or as needed.
Low tidal volume ventilationOther
Low tidal volume ventilation strategy (ARDSnet)
Transpulmonary pressure-directed ventilation (EPVent)Other
Transpulmonary pressure-directed ventilation using measurements from the esophageal balloon.
| Study group | Role | What they receive |
|---|---|---|
| EPVent | Experimental | All patients will have an esophageal balloon placed for the purpose of obtaining transpulmonary pressure measurements. The intervention group will undergo transpulmonary pressure-directed controlled mechanical ventilation using parameters directed by the initial balloon measurements. Driving pressures will be adjusted to maintain a transpulmonary plateau pressure of less then 30. The PEEP setting will be set to achieve a transpulmonary end expiratory pressure of 0. Repeat PES measurements will be done at 24, 48 and 72 hours following the initial measurements. Additional measurements will be taken as clinically indicated. Ventilator management by PES measurements will continue for a period of 72 hours. Receives: Procedure: Placement of an esophageal balloon measurements; Other: Transpulmonary pressure-directed ventilation (EPVent) |
| Control | Active comparator | All patients will have an esophageal balloon placed for the purpose of obtaining transpulmonary pressure measurements. The control group will be managed using the low tidal volume strategy laid out by the NIHBLI ARDSnet study. These recommendations include a set tidal volume of 6 ml/ kg. Respiratory rate and PEEP are set to maintain adequate ventilation and oxygenation. These settings will be continued for a period of 72 hours. Receives: Procedure: Placement of an esophageal balloon measurements; Other: Low tidal volume ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation as measured by the PO2/FiO2 (P/F) ratio
Measured: 72 hours from enrollment
Secondary outcomes (4)
Ventilator free days
Measured: At 28 days
Markers of inflammation
Measured: In first 72 hours
Mortality
Measured: At 28, 90 and 180 days
Length of stay
Measured: Hospital and ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startMay 2004
- Primary completionAug 2007
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Daniel Talmor, Beth Israel Deaconess Medical Center
- Investigators
- Daniel S Talmor, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127491
- Sponsor's protocol ID
- 2004P000011
- Other IDs
- R01HL052586
- Status last verified
- Feb 2017
- First submitted
- 4 Aug 2005
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Loring SH, O'Donnell CR, Behazin N, Malhotra A, Sarge T, Ritz R, Novack V, Talmor D. Esophageal pressures in acute lung injury: do they represent artifact or useful information about transpulmonary pressure, chest wall mechanics, and lung stress? J Appl Physiol (1985). 2010 Mar;108(3):515-22. doi: 10.1152/japplphysiol.00835.2009. Epub 2009 Dec 17.
PubMed 20019160Sarge T, Talmor D. Targeting transpulmonary pressure to prevent ventilator induced lung injury. Minerva Anestesiol. 2009 May;75(5):293-9.
PubMed 19412147Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
PubMed 19001507Schaefer MS, Loring SH, Talmor D, Baedorf-Kassis EN. Comparison of mechanical power estimations in mechanically ventilated patients with ARDS: a secondary data analysis from the EPVent study. Intensive Care Med. 2021 Jan;47(1):130-132. doi: 10.1007/s00134-020-06282-1. Epub 2020 Oct 19. No abstract available.
PubMed 33078240Talmor D, Sarge T, Legedza A, O'Donnell CR, Ritz R, Loring SH, Malhotra A. Cytokine release following recruitment maneuvers. Chest. 2007 Nov;132(5):1434-9. doi: 10.1378/chest.07-1551. Epub 2007 Oct 9.
PubMed 17925413
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RCT of Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury
- ClinicalTrials.gov ID
- NCT00127491
- Acronym / sponsor ID
- 2004P000011
- Keywords
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Mechanical Ventilation, Esophageal Pressures, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Aug 2005 (estimated)
- 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 purpose of this study is to see whether esophageal pressure (PES) measurements will allow the investigators to choose the best method of mechanical ventilation in patients with acute lung injury (ALI).
Detailed description
The current standard of practice for ventilating patients with acute respiratory distress syndrome (ARDS) is the ARDSnet protocol (N Engl J Med 2000; 342:1301-1308) which has been shown to improve survival by limiting tidal volumes and thus preventing over distention of the lungs. However, the lungs can also be damaged by under-inflation during mechanical ventilation, and current practice ignores the effects of chest wall compression of the lungs, which can cause under-inflation. The investigators have observed that a fraction of critically ill patients with apparent ARDS have lung function abnormalities caused by extrinsic compression which can be estimated by PES measurements. Changing ventilator settings to apply normal physiological pressure to the lung has been beneficial in many such patients. This protocol will formally test the clinical utility of PES measurements in patients with ARDS.
This is a randomized controlled trial of therapy directed by esophageal balloon measurements (PES) versus therapy directed by ARDSnet protocol, the current standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPVent | Experimental | Procedure: Placement of an esophageal balloon measurements, Other: Transpulmonary pressure-directed ventilation (EPVent)All patients will have an esophageal balloon placed for the purpose of obtaining transpulmonary pressure measurements. The intervention group will undergo transpulmonary pressure-directed controlled mechanical ventilation using parameters directed by the initial balloon measurements. Driving pressures will be adjusted to maintain a transpulmonary plateau pressure of less then 30. The PEEP setting will be set to achieve a transpulmonary end expiratory pressure of 0. Repeat PES measurements will be done at 24, 48 and 72 hours following the initial measurements. Additional measurements will be taken as clinically indicated. Ventilator management by PES measurements will continue for a period of 72 hours. |
| Control | Active comparator | Procedure: Placement of an esophageal balloon measurements, Other: Low tidal volume ventilationAll patients will have an esophageal balloon placed for the purpose of obtaining transpulmonary pressure measurements. The control group will be managed using the low tidal volume strategy laid out by the NIHBLI ARDSnet study. These recommendations include a set tidal volume of 6 ml/ kg. Respiratory rate and PEEP are set to maintain adequate ventilation and oxygenation. These settings will be continued for a period of 72 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PaO2/FiO2 ratio < 300
- Acute onset
- Bilateral infiltrates on chest radiography
- PAOP < 18 or, in patients without a pulmonary artery catheter, no other evidence of abnormal cardiac function
Key exclusion criteria (6 listed)
- Patients with esophageal varices
- Patients with esophageal trauma
- Patients with recent esophageal surgery
- Patients with coagulopathy (platelets < 80k or International Normalized Ratio [INR]> 2 )
- Post transplant patients
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 |
|---|---|---|
| Placement of an esophageal balloon measurementsIn both groups an esophageal balloon will be placed and baseline measurements recorded. In the EP group the mechanical ventilation settings will be determined based on these measurements. In the control group measurements will be recorded but ventilation will be based in the existing standard of care wich is the ARDSnet low tidal volume ventilation study. measurements will be repeated at 24, 48 and 72 hours or as needed. | Procedure or surgery | Control, EPVent |
| Low tidal volume ventilationLow tidal volume ventilation strategy (ARDSnet) | Other | Control |
| Transpulmonary pressure-directed ventilation (EPVent)Transpulmonary pressure-directed ventilation using measurements from the esophageal balloon. | Other | EPVent |
Primary outcome
Oxygenation as measured by the PO2/FiO2 (P/F) ratio
Time frame: 72 hours from enrollment
4 secondary outcomes
Ventilator free days
Time frame: At 28 days
Markers of inflammation
Time frame: In first 72 hours
Mortality
Time frame: At 28, 90 and 180 days
Length of stay
Time frame: Hospital and ICU
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 27 Feb 2017.
- Background: PubMed 20019160Loring SH, O'Donnell CR, Behazin N, Malhotra A, Sarge T, Ritz R, Novack V, Talmor D. Esophageal pressures in acute lung injury: do they represent artifact or useful information about transpulmonary pressure, chest wall mechanics, and lung stress? J Appl Physiol (1985). 2010 Mar;108(3):515-22. doi: 10.1152/japplphysiol.00835.2009. Epub 2009 Dec 17.
- Background: PubMed 19412147Sarge T, Talmor D. Targeting transpulmonary pressure to prevent ventilator induced lung injury. Minerva Anestesiol. 2009 May;75(5):293-9.
- Results publication: PubMed 19001507Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
- Derived from this study: PubMed 33078240Schaefer MS, Loring SH, Talmor D, Baedorf-Kassis EN. Comparison of mechanical power estimations in mechanically ventilated patients with ARDS: a secondary data analysis from the EPVent study. Intensive Care Med. 2021 Jan;47(1):130-132. doi: 10.1007/s00134-020-06282-1. Epub 2020 Oct 19. No abstract available.
- Derived from this study: PubMed 17925413Talmor D, Sarge T, Legedza A, O'Donnell CR, Ritz R, Loring SH, Malhotra A. Cytokine release following recruitment maneuvers. Chest. 2007 Nov;132(5):1434-9. doi: 10.1378/chest.07-1551. Epub 2007 Oct 9.
- 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.
Daniel S Talmor, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of an esophageal balloon measurements, Low tidal volume ventilation and Transpulmonary pressure-directed ventilation (EPVent) in people with Acute Lung Injury and Acute Respiratory Distress Syndrome, run by Beth Israel Deaconess Medical Center 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 5 inclusion and 6 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 27 Feb 2017. 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?
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?
Oxygenation as measured by the PO2/FiO2 (P/F) ratio (time frame: 72 hours from enrollment). 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 NCT00127491, which also lists 5 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 27 Feb 2017.