Acute Respiratory FailureNCT01668368
Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance
A study testing esophageal balloon in people with Acute Respiratory Failure and ARDS, run by Wolfson Medical Center.
Trial summary
Patients with acute respiratory failure exhibiting decreased respiratory system compliance with hypoxemia or carbon dioxide retention are often difficult to ventilate with current guidelines that limit applied plateau pressure Yet, these guidelines do not take into consideration chest wall mechanics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, ARDS
- What is being tested?
- esophageal balloon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Sep 2013
- 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
- To be included in the study a prerequisite of high peak Inspiratory pressure (plateau pressure of up to 30 cmH2O) had to be present, and at least one of the following four inclusion criteria had to be met.
- 1 - Low Total Respiratory system compliance (CT), defined as less than 50ml/cmH2O. 2 - P/F ratio of less than 300. 3 - Need for a PEEP greater than 10 cmH2O to maintain SaO2 of > 90%. 4 - PCO2 over 60 mmHg, or PH less than 7.2 that is attributed to respiratory acidosis.
Who cannot join
- Patients with any of the following were excluded from the study. Previous lung or chest wall surgery, previous esophageal surgery, known Achalasia or any other esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any significant chest wall abnormality such as kyphoskoliosis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance Approach Guided by Esophageal Pressure in Acute Respiratory Failure.
Patients with acute respiratory failure exhibiting decreased respiratory system compliance with hypoxemia or carbon dioxide retention are often difficult to ventilate with current guidelines that limit applied plateau pressure Yet, these guidelines do not take into consideration chest wall mechanics. The investigators sought to determine whether partition of the respiratory system into its components by measuring esophageal pressure and thus assessment of pleural pressure, would help in patients with acute respiratory failure to identify the factors contributing to low respiratory system compliance.
Read the detailed description
Identifying the dominant factor affecting respiratory system compliance by measuring transpulmonary pressure may better direct and optimize mechanical ventilation. Thus, instead of limiting mechanical ventilation by plateau pressure, PEEP and Inspiratory pressure adjustment would be individualized specifically for each patient's lung compliance as indicated by transpulmonary pressure.
The main goal of this approach is to specifically target transpulmonary pressure instead of plateau pressure, and therefore achieve the best Lung compliance with the least transpulmonary pressure possible.
- Conditions
- Acute Respiratory Failure, ARDS
- Being tested
- esophageal balloon
- Keywords
- ARDS, Esophageal pressure, pleural pressure, pulmonary compliance
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophageal balloonOther
Also called pleural pressure
esophageal pressure as a surrogate for pleural pressure
| Study group | Role | What they receive |
|---|---|---|
| Esophageal balloon group | Other | Esophageal balloon will be inserted, and esophageal pressure will be measured in patients with acute respiratory failure.
Intervention - PEEP and Inspiratory pressure will be adjusted according to the measured esophageal pressure. Receives: Other: esophageal balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation
Measured: 1 year
Secondary outcomes (1)
lung compliance, expressed as ml/cmH2O.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (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 Acute 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Soroksky Arie, Wolfson Medical Center
- Investigators
- Arie Soroksky, MD, Principal investigator, Wolfson MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668368
- Sponsor's protocol ID
- 0082-12-WOMC
- Status last verified
- Aug 2012
- First submitted
- 23 Jul 2012
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Talmor 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 19001507
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance Approach Guided by Esophageal Pressure in Acute Respiratory Failure.
- ClinicalTrials.gov ID
- NCT01668368
- Acronym / sponsor ID
- 0082-12-WOMC
- Conditions
- Acute Respiratory Failure, ARDS
- Keywords
- ARDS, Esophageal pressure, pleural pressure, pulmonary compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 20 Aug 2012 (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.
Patients with acute respiratory failure exhibiting decreased respiratory system compliance with hypoxemia or carbon dioxide retention are often difficult to ventilate with current guidelines that limit applied plateau pressure Yet, these guidelines do not take into consideration chest wall mechanics. The investigators sought to determine whether partition of the respiratory system into its components by measuring esophageal pressure and thus assessment of pleural pressure, would help in patients with acute respiratory failure to identify the factors contributing to low respiratory system compliance.
Detailed description
Identifying the dominant factor affecting respiratory system compliance by measuring transpulmonary pressure may better direct and optimize mechanical ventilation. Thus, instead of limiting mechanical ventilation by plateau pressure, PEEP and Inspiratory pressure adjustment would be individualized specifically for each patient's lung compliance as indicated by transpulmonary pressure.
The main goal of this approach is to specifically target transpulmonary pressure instead of plateau pressure, and therefore achieve the best Lung compliance with the least transpulmonary pressure possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esophageal balloon group | Other | Other: esophageal balloonEsophageal balloon will be inserted, and esophageal pressure will be measured in patients with acute respiratory failure. Intervention - PEEP and Inspiratory pressure will be adjusted according to the measured esophageal pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To be included in the study a prerequisite of high peak Inspiratory pressure (plateau pressure of up to 30 cmH2O) had to be present, and at least one of the following four inclusion criteria had to be met.
- 1 - Low Total Respiratory system compliance (CT), defined as less than 50ml/cmH2O. 2 - P/F ratio of less than 300. 3 - Need for a PEEP greater than 10 cmH2O to maintain SaO2 of > 90%. 4 - PCO2 over 60 mmHg, or PH less than 7.2 that is attributed to respiratory acidosis.
Key exclusion criteria (1 listed)
- Patients with any of the following were excluded from the study. Previous lung or chest wall surgery, previous esophageal surgery, known Achalasia or any other esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any significant chest wall abnormality such as kyphoskoliosis.
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 |
|---|---|---|
| esophageal balloonAlso: pleural pressureesophageal pressure as a surrogate for pleural pressure | Other | Esophageal balloon group |
Primary outcome
Oxygenation
Time frame: 1 year
1 secondary outcome
lung compliance, expressed as ml/cmH2O.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
- 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.
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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.
Arie Soroksky, MD principal investigator
Wolfson MC
Questions about this trial
What is this clinical trial studying?
A study testing esophageal balloon in people with Acute Respiratory Failure and ARDS, run by Wolfson Medical Center.
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 2 inclusion and 1 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 20 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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 Arie Soroksky, M.D. (972-50-4056787, soroksky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation (time frame: 1 year). 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 NCT01668368, 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 20 Aug 2012.