Acute Respiratory Distress SyndromeNCT00538161
Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient
A study testing Ventilation strategy in people with Acute Respiratory Distress Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
We propose that as low tidal volume ventilation has proven to be beneficial in patients with established ARDS it may have a role in preventing the onset of acute lung injury in the cardiac surgical population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Ventilation strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jan 2011
- 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 coming in for cardiac surgical procedures will be recruited into the study.
- Both men and women will be recruited into the study.
- All patients over the age of 18 will be recruited into the study.
- Discussion between the surgeon and the primary investigator will happen prior to approaching the patient to obtain informed consent.
Who cannot join
- Patients with preexisting respiratory failure and active infection will be excluded from the study.
- Patients undergoing one lung ventilation during surgery will be excluded from the study.
- Patients undergoing emergency cardiac surgery will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
We propose that as low tidal volume ventilation has proven to be beneficial in patients with established ARDS it may have a role in preventing the onset of acute lung injury in the cardiac surgical population. Institution of low tidal volume ventilation in the operating room may reduce the release of the cytokines and interleukins that have been known to contribute to the development of acute lung injury. In this study, we propose that the institution of low tidal volume ventilation in the operating room will reduce the incidence of acute lung injury. Measurement of PaO2 to FiO2 ratio twenty four and forty eight hours post operatively will help determine if there is a difference in oxygenation between the two groups. Chest X-ray findings, time to extubation and length of ICU stay will also determine if there is a role for low tidal volume ventilation in the operating room. We will also attempt to establish a causative mechanism by measuring plasma levels of cytokines known to be associated with the development of ARDS.
Read the detailed description
Methods- A single center randomized controlled trial was undertaken in 149 patients comparing ventilation with 6 ml/kg TV to ventilation with 10 ml/kg TV in patients undergoing elective cardiac surgery. Study ventilator settings were applied immediately after induction of anesthesia and continued throughout surgery and the subsequent Intensive Care Unit stay. The primary endpoint of the study was time to extubation. Secondary endpoints included the proportion of patients extubated at 6 hours, indices of lung mechanics and gas exchange as well as patient clinical outcomes.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Ventilation strategy
- Keywords
- Acute lung injury, cardiac surgery, The incidence of ARDS after elective cardiac surgery is 1-3%, The impairment of lung function and oxygenation may occur in 20-80% of patients undergoing surgery., The purpose of this study is to assess the efficacy of low tidal volume ventilation., Reducing interleukin and cytokine production may prevent or reduce the incidence of acute lung injury.
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation strategyOther
| Study group | Role | What they receive |
|---|---|---|
| Low tidal volume arm | Experimental | Not described Receives: Other: Ventilation strategy |
| Conventional tidal volume arm | Active comparator | Not described Receives: Other: Ventilation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to extubation
Measured: the time patient was extubated in the ICU
Secondary outcomes (1)
Oxygenation at 4 hours, 8 hours, 12 hours and 24 hours post surgery.
Measured: measurement of blood gas at 4, 8 , 12 and 24 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sugantha Sundar, Beth Israel Deaconess Medical Center
- Investigators
- Daniel Talmor, MD, Study director, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538161
- Sponsor's protocol ID
- 2007P000113
- Status last verified
- Mar 2017
- First submitted
- 30 Sep 2007
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient
- ClinicalTrials.gov ID
- NCT00538161
- Acronym / sponsor ID
- 2007P000113
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute lung injury, cardiac surgery, The incidence of ARDS after elective cardiac surgery is 1-3%, The impairment of lung function and oxygenation may occur in 20-80% of patients undergoing surgery., The purpose of this study is to assess the efficacy of low tidal volume ventilation., Reducing interleukin and cytokine production may prevent or reduce the incidence of acute lung injury.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 2 Oct 2007 (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.
We propose that as low tidal volume ventilation has proven to be beneficial in patients with established ARDS it may have a role in preventing the onset of acute lung injury in the cardiac surgical population. Institution of low tidal volume ventilation in the operating room may reduce the release of the cytokines and interleukins that have been known to contribute to the development of acute lung injury. In this study, we propose that the institution of low tidal volume ventilation in the operating room will reduce the incidence of acute lung injury. Measurement of PaO2 to FiO2 ratio twenty four and forty eight hours post operatively will help determine if there is a difference in oxygenation between the two groups. Chest X-ray findings, time to extubation and length of ICU stay will also determine if there is a role for low tidal volume ventilation in the operating room. We will also attempt to establish a causative mechanism by measuring plasma levels of cytokines known to be associated with the development of ARDS.
Detailed description
Methods- A single center randomized controlled trial was undertaken in 149 patients comparing ventilation with 6 ml/kg TV to ventilation with 10 ml/kg TV in patients undergoing elective cardiac surgery. Study ventilator settings were applied immediately after induction of anesthesia and continued throughout surgery and the subsequent Intensive Care Unit stay. The primary endpoint of the study was time to extubation. Secondary endpoints included the proportion of patients extubated at 6 hours, indices of lung mechanics and gas exchange as well as patient clinical outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low tidal volume arm | Experimental | Other: Ventilation strategy |
| Conventional tidal volume arm | Active comparator | Other: Ventilation strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients coming in for cardiac surgical procedures will be recruited into the study.
- Both men and women will be recruited into the study.
- All patients over the age of 18 will be recruited into the study.
- Discussion between the surgeon and the primary investigator will happen prior to approaching the patient to obtain informed consent.
Key exclusion criteria (3 listed)
- Patients with preexisting respiratory failure and active infection will be excluded from the study.
- Patients undergoing one lung ventilation during surgery will be excluded from the study.
- Patients undergoing emergency cardiac surgery will be excluded from the study.
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 |
|---|---|---|
| Ventilation strategy | Other | Conventional tidal volume arm, Low tidal volume arm |
Primary outcome
Time to extubation
Time frame: the time patient was extubated in the ICU
1 secondary outcome
Oxygenation at 4 hours, 8 hours, 12 hours and 24 hours post surgery.
Time frame: measurement of blood gas at 4, 8 , 12 and 24 hours post surgery
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 17 Mar 2017.
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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 Talmor, MD study director
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 Ventilation strategy in people with 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 4 inclusion and 3 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 17 Mar 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?
Time to extubation (time frame: the time patient was extubated in the ICU). 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 17 Mar 2017.