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Trial record 15 of 199 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

Adaptive Support Ventilation in Acute Respiratory Distress Syndrome (ARDS)

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ClinicalTrials.gov Identifier: NCT03715751
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Talmor, Beth Israel Deaconess Medical Center

Brief Summary:
The purpose of this protocol is to compare standard of care lung protective ventilation settings with an automated ventilator setting, called Adaptive Support Ventilation (ASV), in patients with acute respiratory distress syndrome (ARDS). This study will compare measurements (i.e. tidal volumes, driving pressure, respiratory rate (RR), compliance, peak airway pressures, plateau pressures, PEEP) with each ventilator technique, and will measure esophageal pressures to compare transpulmonary and respiratory system mechanics.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Other: ASV Other: Lung Protective Ventilation Not Applicable

Detailed Description:

This study will compare two different modes of mechanical ventilation: standard lung protective controlled mandatory ventilation and Adaptive Support Ventilation. The investigators will enroll adult patients with ARDS who are mechanically ventilated and admitted to intensive care units, capturing a population with respiratory failure and significant critical illness. Patient mechanics during each ventilation strategy will be compared before and after crossover.

After obtaining informed consent, the investigators will place an esophageal balloon which will be used for simultaneous measurements of airway pressures (Pao) and esophageal pressures (Pes), to estimate transpulmonary pressures (PL = Pao - Pes), while also measuring Flow and Volume. Use of esophageal balloon catheters is common practice in the ICUs, and standard of care at Beth Israel Deaconess Medical Center is to use these balloons in patients with ARDS. Both the respiratory therapy and physician staff are very comfortable with placement and use. The esophageal balloon will be left in place until extubation. If the balloon is dislodged or removed for clinical purposes, it will not be replaced solely for research purposes unless it occurs on the first day of study measurements.

Patients will then be randomized to be switched to ASV immediately or to be maintained on their current lung protective ventilation settings.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Adaptive Support Ventilation in Acute Respiratory Distress Syndrome
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2020


Arm Intervention/treatment
Active Comparator: ASV
Patients in this arm will have the ventilator adjusted per results of recent arterial blood gas. Esophageal balloon placement will be confirmed. Study team will measure several tidal breaths, end-expiratory and end-inspiratory ventilator holds. Then PEEP will be adjusted to achieve desired end-expiratory transpulmonary pressures, Fraction of Inspired Oxygen (FiO2) adjusted as needed to achieve SpO2>95%, and Tidal Volume (Vt) adjusted to 6cc/kg (IBW). Respiratory Rate (RR) will be adjusted to target the same minute ventilation achieved prior to any change in Vt. Patients will then be switched to ASV mode. The percentage minute volume (%minVol) will be adjusted to target the same minute ventilation as was achieved before the change. Settings will be maintained for approximately 1-2 hours, after which breath hold measurements will be repeated and another blood gas drawn.
Other: ASV
Adaptive Support Ventilation
Other Name: Adaptive Support Ventilation

Active Comparator: Lung Protective Ventilation
Patients in this arm will have the ventilator adjusted per results of recent arterial blood gas. Esophageal balloon placement will be confirmed. Study team will measure several tidal breaths, end-expiratory and end-inspiratory ventilator holds. Then PEEP will be adjusted to achieve desired end-expiratory transpulmonary pressures, Fraction of Inspired Oxygen (FiO2) adjusted as needed to achieve SpO2>95%, and Tidal Volume (Vt) adjusted to 6cc/kg (IBW). Respiratory Rate (RR) will be adjusted (while leaving the Vt at 6cc/kg) to achieve the same minute ventilation. Patients will then be maintained on their current lung protective ventilation settings for approximately 1-2 hours, after which breath hold measurements will be repeated and another blood gas drawn.
Other: Lung Protective Ventilation
Targeted tidal volume of 6cc/Kg, Positive Inspiratory Pressure titrated per ARDS guidelines.




Primary Outcome Measures :
  1. Tidal Volume [ Time Frame: Day 1 ]
    Lung tidal volume in both ventilation modes (mL)


Secondary Outcome Measures :
  1. Driving Pressure (cmH20) [ Time Frame: Day 1 ]
    Driving pressure in both ventilation modes

  2. Respiratory rate (BPM) [ Time Frame: Day 1 ]
    Respiratory Rate in both ventilation modes

  3. Oxygenation (SpO2%) [ Time Frame: Day 1 ]
    Oxygenation (SpO2%) in both ventilation modes

  4. CO2 clearance [ Time Frame: Day 1 ]
    CO2 clearance in both ventilation modes

  5. Blood Gas pH [ Time Frame: Day 1 ]
    Blood Gas pH (units) in both ventilation modes

  6. Blood Gas Partial Pressure of Oxygen [ Time Frame: Day 1 ]
    Partial pressure of oxygen (PaO2) (mm Hg) in both ventilation modes

  7. Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg) [ Time Frame: Day 1 ]
    Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg) in both ventilation modes

  8. Composite measure (lung protectiveness) - Asynchrony index [ Time Frame: Day 1 ]
    Asynchrony index

  9. Composite measure (lung protectiveness) - Number of Adjustments [ Time Frame: Day 1 ]
    Number of Adjustments

  10. Composite measure (lung protectiveness) - Time with tidal volumes under 6cc/kg [ Time Frame: Day 1 ]
    Time spent with tidal volumes less than or equal to 6cc/kg

  11. Composite measure (lung protectiveness) - Driving pressures less than 15 [ Time Frame: Day 1 ]
    Time spent at or under Driving pressures less than 15

  12. Composite measure (lung protectiveness) - Plateau Pressure <30 [ Time Frame: Day 1 ]
    Time spent at or under Plateau Pressure <30

  13. Composite measure (lung protectiveness) - Oxygen saturation by pulse Oximetry (SpO2) >88% [ Time Frame: Day 1 ]
    Time spent at or under Oxygen saturation by pulse Oximetry (SpO2) >88%

  14. Time to extubation [ Time Frame: 30 Days ]
    Time to liberation from mechanical ventilation (days)

  15. ICU length of stay [ Time Frame: 90 Days ]
    Time to ICU discharge (days)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients ≥ 18 years of age
  2. Receiving mechanical ventilation in an intensive care unit
  3. ARDS, as defined by the Berlin definition:

    1. Hypoxemic respiratory failure with PaO2 / FiO2 ratio < 300 mmHg
    2. Bilateral alveolar/interstitial infiltrates on chest x-ray, with opacities not present for more than 7 days
    3. Respiratory failure not fully explained by cardiac failure or fluid overload
    4. Intubation on mechanical ventilation and receiving PEEP ≥ 5 cm H2O
  4. Receiving mechanical ventilation from a Hamilton ventilator, on a controlled mode of ventilation.

Exclusion Criteria:

  1. Clinical team refusal
  2. Esophageal injury or contraindication precluding placement of the esophageal balloon

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715751


Contacts
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Contact: Elias Baedorf Kassis, MD 6176328046 enbaedor@bidmc.harvard.edu
Contact: Daniel Talmor, MD, MPH 6176672902 dtalmor@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Elias Baedorf Kassis, MD    617-632-8046    enbaedor@bidmc.harvard.edu   
Contact: Daniel Talmor, MD, MPH    6176672902    dtalmor@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Daniel Talmor, MD, MPH Beth Israel Deaconess Medical Center

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Responsible Party: Daniel Talmor, Edward Lowenstein Professor of Anesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03715751     History of Changes
Other Study ID Numbers: 2017P000596
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Talmor, Beth Israel Deaconess Medical Center:
Adaptive Support Ventilation
ARDS
Esophageal Pressure
Mechanical Ventilation
Transpulmonary Pressure
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury