Acute Lung InjuryPhase 2PRESSURENCT00793013
Airway Pressure Release Ventilation (APRV) Compared to ARDSnet Ventilation
A Phase 2 study testing Airway Pressure Release Ventilation (APRV) mode in people with Acute Lung Injury and Adult Respiratory Distress Syndrome, run by University of Tennessee, Chattanooga at 1 site in United States.
Trial summary
Traditional modes of ventilation have failed to improve patient survival. Subsequent observations that elevated airway pressures observed in traditional forms of ventilation resulted in barotrauma and extension of ALI lead to the evolution of low volume cycled ventilation as a potentially better ventilatory modality… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Lung Injury, Adult Respiratory Distress Syndrome, Kidney Injury
- What is being tested?
- Airway Pressure Release Ventilation (APRV) mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 2 Nov 2020
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted to the Internal Medicine service at the Baroness Erlanger Hospital of the University of Tennessee College of Medicine with hypoxia (O2 saturation < 93%) and pulmonary distress, will be screened for study participation.
- Patients displaying all the following clinical criteria: acute onset of respiratory failure; hypoxia defined as a PaO2/FiO2 ratio of < 300 Torr; pulmonary capillary wedge pressure less or equal than 18 mm Hg, and/or no clinical evidence of left sided heart failure; and chest x-ray with diffuse bilateral pulmonary infiltrates.
Who cannot join
- Patients receiving conventional volume ventilation with or without PEEP for > 6 hours prior to study enrollment
- Patient's family or surrogate unwilling to give informed consent
- Patients requiring sedation or paralysis for effective ventilation
- Patients known pulmonary embolus within 72 hours of study enrollment
- Patients with close head injuries or evidence of increased intracranial pressure
- Patients with burns over 30% of total body surface area
Show all 13Show fewer
- Pulmonary capillary wedge pressure greater than 18 mm Hg
- CVP > 15 cm H2O
- Patients with B type Naturetic peptide levels > 1000
- Patients with prior history of dilated cardiomyopathy with EF < 25%
- Patients receiving chronic outpatient peritoneal or hemodialysis
- Patients with severe liver disease (as defined by Child-Pugh class C)
- AIDS patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Resuscitation Using Airway Pressure Release Ventilation Improves Recovery From Acute Lung Injury or Adult Respiratory Distress Syndrome and Reduces All Cause Mortality Compared to ARDS Net Low Tidal Volume-Cycled Ventilation.
Traditional modes of ventilation have failed to improve patient survival. Subsequent observations that elevated airway pressures observed in traditional forms of ventilation resulted in barotrauma and extension of ALI lead to the evolution of low volume cycled ventilation as a potentially better ventilatory modality for ARDS. Recent multicenter trials by the NIH-ARDS network have confirmed that low volume ventilation increases the number of ventilatory free days and improves overall patient survival. While reducing mean airway pressure has reduced barotrauma and improved patient survival, it has impaired attempts to improve alveolar recruitment. Alveolar recruitment is important as it improves V/Q mismatch, allows reduction in FIO2 earlier, and decreases the risk of oxygen toxicity. Airway pressure release ventilation (APRV) is a novel ventilatory modality that utilizes controlled positive airway pressure to maximize alveolar recruitment while minimizing barotrauma. In APRV, tidal ventilation occurs between the increase in lung volumes established by the application of CPAP and the relaxation of lung tissue following pressure release. Preliminary studies have suggested that APRV recruits collapsed alveoli and improves oxygenation through a restoration of pulmonary mechanics, but there are no studies indicating the potential overall benefit of APRV in recovery form ALI/ADRS.
Read the detailed description
Low volume ventilation may increase number of ventilatory free days and may improve overall patient survival. While reducing mean airway pressure has reduced barotrauma and improved patient survival, it has impaired attempts to improve alveolar recruitment. Alveolar recruitment is important as it improves V/Q mismatch, allows reduction in FIO2 earlier, and decreases the risk of oxygen toxicity. Airway pressure release ventilation (APRV) is a novel ventilatory modality that utilizes controlled positive airway pressure to maximize alveolar recruitment while minimizing barotrauma. In APRV, tidal ventilation occurs between the increase in lung volumes established by the application of CPAP and the relaxation of lung tissue following pressure release. Preliminary studies have suggested that APRV recruits collapsed alveoli and improves oxygenation through a restoration of pulmonary mechanics, but there are no studies indicating the potential overall benefit of APRV in recovery form ALI/ADRS.
- Being tested
- Volume-Cycled Assist-Control (AC) mode, Airway Pressure Release Ventilation (APRV) mode
- Keywords
- Acute Lung Injury, Adult Respiratory Distress Syndrome, Airway Pressure Release Ventilation, Acute Kidney Injury, Pressure Trial
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume-Cycled Assist-Control (AC) modeDevice
Also called Controlled Mechanical Ventilation (CMV)
- Patients ventilated with volume-cycled assist-control mode with PEEP and goal FIO2 < 40%
- Rate of mandatory time-cycled, pressure controlled breaths,initially at 12 per breaths/min
- Initial tidal volume set at 8mL/kg using predicted body weight (PBW) with a goal of 6mL/kg \& setting positive end-expiratory pressure (PEEP) based on level of initial FiO2
- Inspiratory to Expiratory ratio set at 1:1 to 1:3
- If frequency of triggered breaths increased greater than 10 per min sedation will be increased. If needed,rate of mandatory breaths increased
- Mgmt of PEEP will be conducted as per the ARDSnet Protocol
- Oxygenation goal PaO2: PaO2-55-80 mm Hg O2 Sat: 88-95%
- Tidal volume and respiratory rate adjusted to the desired pH and plateau pressures per ARDSnet protocol
Airway Pressure Release Ventilation (APRV) modeDevice
Also called Controlled Mechanical Ventilation (CMV)
- Ventilation uses Drager Model X1
- Spontaneous breathing allowed throughout ventilatory cycle at 2 airway pressure levels
- Time periods for the high \& low pressure levels can be set independently
- Duration of the lower pressure level will be adjusted to allow expiratory flow to decay to 75% of total volume
- Duration of higher pressure levels will be adjusted to produce 12 pressure shifts per min
- Spontaneous frequency will be targeted for 6 to 18 breaths/per min
- If spontaneous breathing is achieved,level of sedation will be decreased
- If spontaneous respirations are >20 breaths/min, sedation will be increased
- If spontaneous breathing frequency increased greater than 20/per min, sedation was increased and if needed the mechanical frequency increased
| Study group | Role | What they receive |
|---|---|---|
| ARDS Net Low Tidal Volume | Experimental | Not described Receives: Device: Volume-Cycled Assist-Control (AC) mode |
| APRV Ventilation | Experimental | Not described Receives: Device: Airway Pressure Release Ventilation (APRV) mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 28 days or prior to hospital discharge
Secondary outcomes (6)
Number of ventilator-free days
Measured: 28 days or prior to hospital discarge
Length of ICU stay and /or Total hospital days
Measured: 28 days or prior to hospital discharge
To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation on the incidence of of AKI
Measured: 28 days or prior to hospital discharge
To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation on the NGAL, KIM-1, and IL-18 urine biomarkers for AKI
Measured: 28 days or prior to hospital discharge
To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation in maintaining hourly urine output > 0.5 mls/kg/hr
Measured: 28 days or prior to hospital discharge
Will determine urinary aquaporin-2 levels in patients randomized to APRV ventilation versus ARDS net low volume-cycle ventilation
Measured: 28 days or prior to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study start2 Nov 2020
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Why it stopped: IRB approval lapsed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee, Chattanooga
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James A Tumlin, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793013
- Sponsor's protocol ID
- 123456789
- Acronym
- PRESSURE
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2008
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Resuscitation Using Airway Pressure Release Ventilation Improves Recovery From Acute Lung Injury or Adult Respiratory Distress Syndrome and Reduces All Cause Mortality Compared to ARDS Net Low Tidal Volume-Cycled Ventilation.
- ClinicalTrials.gov ID
- NCT00793013
- Acronym / sponsor ID
- PRESSURE / 123456789
- Keywords
- Acute Lung Injury, Adult Respiratory Distress Syndrome, Airway Pressure Release Ventilation, Acute Kidney Injury, Pressure Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB approval lapsed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Tennessee, ChattanoogaUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 18 Nov 2008 (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.
Traditional modes of ventilation have failed to improve patient survival. Subsequent observations that elevated airway pressures observed in traditional forms of ventilation resulted in barotrauma and extension of ALI lead to the evolution of low volume cycled ventilation as a potentially better ventilatory modality for ARDS. Recent multicenter trials by the NIH-ARDS network have confirmed that low volume ventilation increases the number of ventilatory free days and improves overall patient survival. While reducing mean airway pressure has reduced barotrauma and improved patient survival, it has impaired attempts to improve alveolar recruitment. Alveolar recruitment is important as it improves V/Q mismatch, allows reduction in FIO2 earlier, and decreases the risk of oxygen toxicity. Airway pressure release ventilation (APRV) is a novel ventilatory modality that utilizes controlled positive airway pressure to maximize alveolar recruitment while minimizing barotrauma. In APRV, tidal ventilation occurs between the increase in lung volumes established by the application of CPAP and the relaxation of lung tissue following pressure release. Preliminary studies have suggested that APRV recruits collapsed alveoli and improves oxygenation through a restoration of pulmonary mechanics, but there are no studies indicating the potential overall benefit of APRV in recovery form ALI/ADRS.
Detailed description
Low volume ventilation may increase number of ventilatory free days and may improve overall patient survival. While reducing mean airway pressure has reduced barotrauma and improved patient survival, it has impaired attempts to improve alveolar recruitment. Alveolar recruitment is important as it improves V/Q mismatch, allows reduction in FIO2 earlier, and decreases the risk of oxygen toxicity. Airway pressure release ventilation (APRV) is a novel ventilatory modality that utilizes controlled positive airway pressure to maximize alveolar recruitment while minimizing barotrauma. In APRV, tidal ventilation occurs between the increase in lung volumes established by the application of CPAP and the relaxation of lung tissue following pressure release. Preliminary studies have suggested that APRV recruits collapsed alveoli and improves oxygenation through a restoration of pulmonary mechanics, but there are no studies indicating the potential overall benefit of APRV in recovery form ALI/ADRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARDS Net Low Tidal Volume | Experimental | Device: Volume-Cycled Assist-Control (AC) mode |
| APRV Ventilation | Experimental | Device: Airway Pressure Release Ventilation (APRV) mode |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients admitted to the Internal Medicine service at the Baroness Erlanger Hospital of the University of Tennessee College of Medicine with hypoxia (O2 saturation < 93%) and pulmonary distress, will be screened for study participation.
- Patients displaying all the following clinical criteria: acute onset of respiratory failure; hypoxia defined as a PaO2/FiO2 ratio of < 300 Torr; pulmonary capillary wedge pressure less or equal than 18 mm Hg, and/or no clinical evidence of left sided heart failure; and chest x-ray with diffuse bilateral pulmonary infiltrates.
Key exclusion criteria (13 listed)
- Patients receiving conventional volume ventilation with or without PEEP for > 6 hours prior to study enrollment
- Patient's family or surrogate unwilling to give informed consent
- Patients requiring sedation or paralysis for effective ventilation
- Patients known pulmonary embolus within 72 hours of study enrollment
- Patients with close head injuries or evidence of increased intracranial pressure
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 |
|---|---|---|
| Volume-Cycled Assist-Control (AC) modeAlso: Controlled Mechanical Ventilation (CMV)1. Patients ventilated with volume-cycled assist-control mode with PEEP and goal FIO2 < 40% 2. Rate of mandatory time-cycled, pressure controlled breaths,initially at 12 per breaths/min 3. Initial tidal volume set at 8mL/kg using predicted body weight (PBW) with a goal of 6mL/kg \& setting positive end-expiratory pressure (PEEP) based on level of initial FiO2 4. Inspiratory to Expiratory ratio set at 1:1 to 1:3 5. If frequency of triggered breaths increased greater than 10 per min sedation will be increased. If needed,rate of mandatory breaths increased 6. Mgmt of PEEP will be conducted as per the ARDSnet Protocol 7. Oxygenation goal PaO2: PaO2-55-80 mm Hg O2 Sat: 88-95% 8. Tidal volume and respiratory rate adjusted to the desired pH and plateau pressures per ARDSnet protocol | Device | ARDS Net Low Tidal Volume |
| Airway Pressure Release Ventilation (APRV) modeAlso: Controlled Mechanical Ventilation (CMV)1. Ventilation uses Drager Model X1 2. Spontaneous breathing allowed throughout ventilatory cycle at 2 airway pressure levels 3. Time periods for the high \& low pressure levels can be set independently 4. Duration of the lower pressure level will be adjusted to allow expiratory flow to decay to 75% of total volume 5. Duration of higher pressure levels will be adjusted to produce 12 pressure shifts per min 6. Spontaneous frequency will be targeted for 6 to 18 breaths/per min 7. If spontaneous breathing is achieved,level of sedation will be decreased 8. If spontaneous respirations are >20 breaths/min, sedation will be increased 9. If spontaneous breathing frequency increased greater than 20/per min, sedation was increased and if needed the mechanical frequency increased | Device | APRV Ventilation |
Primary outcome
All cause mortality
Time frame: 28 days or prior to hospital discharge
6 secondary outcomes
Number of ventilator-free days
Time frame: 28 days or prior to hospital discarge
Length of ICU stay and /or Total hospital days
Time frame: 28 days or prior to hospital discharge
To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation on the incidence of of AKI
Time frame: 28 days or prior to hospital discharge
To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation on the NGAL, KIM-1, and IL-18 urine biomarkers for AKI
Time frame: 28 days or prior to hospital discharge
To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation in maintaining hourly urine output > 0.5 mls/kg/hr
Time frame: 28 days or prior to hospital discharge
Will determine urinary aquaporin-2 levels in patients randomized to APRV ventilation versus ARDS net low volume-cycle ventilation
Time frame: 28 days or prior to hospital discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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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.
James A Tumlin, MD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Airway Pressure Release Ventilation (APRV) mode in people with Acute Lung Injury and Adult Respiratory Distress Syndrome, run by University of Tennessee, Chattanooga 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 2 inclusion and 13 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: withdrawn, as of the sponsor's last update on 4 Nov 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
All cause mortality (time frame: 28 days or prior to hospital discharge). 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 4 Nov 2020.