Variable Ventilation During Acute Respiratory Failure
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2012 |
| End Date: | October 2016 |
| Contact: | Allan Walkey, MD, MSc |
| Email: | allan.walkey@bmc.org |
| Phone: | 617-638-4860 |
Acute respiratory failure requiring support with mechanical ventilation occurs with an
incidence of 77-100 per 100,000 person-years and accounts for half of all patients admitted
to the intensive care unit. Major causes of acute respiratory failure include pneumonia,
asthma, emphysema, and acute lung injury. These causes of acute respiratory failure may
result in partial lung collapse (atelectasis), and airway narrowing
(bronchoconstriction)that result in decreased oxygen levels requiring support with the
ventilator. The prolonged inactivity in the supine position associated with mechanical
ventilation can further result in atelectasis requiring increased oxygen supplementation
through the ventilator.
The current standard of care in acute respiratory failure is a strategy of mechanical
ventilation using a single lung volume delivered repeatedly. However, the current standard
mechanical ventilation strategy is not consistent with the variability in respiration of
healthy humans and has been shown to contribute to increased lung injury in some studies.
The mortality associated with acute respiratory failure is high, 30-40%. Thus, improvements
in mechanical ventilation strategies that improve oxygen levels and potentially decrease
further lung injury delivered by the ventilator are warranted.
Recent studies by BU Professor Bela Suki and others in humans and animals with acute lung
injury, bronchoconstriction, and atelectasis have shown that varying the lung volumes
delivered by a ventilator significantly decreases biomarkers of lung injury, improves lung
mechanics, and increases oxygenation when compared to identical mean volumes of
conventional, monotonous low lung volume ventilation.
Therefore, we propose a first-in-human, Phase I study to evaluate the safety of this novel
mode of ventilation, Variable Ventilation, during acute respiratory failure
incidence of 77-100 per 100,000 person-years and accounts for half of all patients admitted
to the intensive care unit. Major causes of acute respiratory failure include pneumonia,
asthma, emphysema, and acute lung injury. These causes of acute respiratory failure may
result in partial lung collapse (atelectasis), and airway narrowing
(bronchoconstriction)that result in decreased oxygen levels requiring support with the
ventilator. The prolonged inactivity in the supine position associated with mechanical
ventilation can further result in atelectasis requiring increased oxygen supplementation
through the ventilator.
The current standard of care in acute respiratory failure is a strategy of mechanical
ventilation using a single lung volume delivered repeatedly. However, the current standard
mechanical ventilation strategy is not consistent with the variability in respiration of
healthy humans and has been shown to contribute to increased lung injury in some studies.
The mortality associated with acute respiratory failure is high, 30-40%. Thus, improvements
in mechanical ventilation strategies that improve oxygen levels and potentially decrease
further lung injury delivered by the ventilator are warranted.
Recent studies by BU Professor Bela Suki and others in humans and animals with acute lung
injury, bronchoconstriction, and atelectasis have shown that varying the lung volumes
delivered by a ventilator significantly decreases biomarkers of lung injury, improves lung
mechanics, and increases oxygenation when compared to identical mean volumes of
conventional, monotonous low lung volume ventilation.
Therefore, we propose a first-in-human, Phase I study to evaluate the safety of this novel
mode of ventilation, Variable Ventilation, during acute respiratory failure
Inclusion criteria
1. Age > or equal to 18
2. Requires mechanical ventilation using a volume-controlled mode.
3. Admitted to Boston Medical Center Surgical, Medical, or Coronary Intensive Care Unit
4. Evidence of impaired oxygenation on mechanical ventilator defined by PaO2/FiO2 ratio
less than 350 (corresponding to an A-a gradient of approximately 100) or SatO2/FiO2
ratio less than 358 (requiring O2 saturation less than or equal to 97%).
5. Meets "Clinical Stability Criteria" (on maximum of one vasopressor medication) for at
least one hour prior to start of study protocol:
5a. Hemodynamically stable: mean arterial pressure greater than 60 mmHg, heart rate
greater than 50 and less than 130 bpm 5b. Respiratory system stable: Respiratory rate less
than 35 bpm, O2 saturation greater than 88%, peak pressure on ventilator less than 40 cm
H20, FiO2 not greater than 0.80, PEEP level not greater than 12.5 cm H2O, requires
suctioning less than once hourly.
5c. Acid-base stability: pH greater than 7.2 and less than 7.55 5d. Neurologic system
stable: No agitation as defined by a Riker SAS Score between 2 (very sedated) and 4 (calm
and cooperative) 6. Assent of primary ICU care team
Exclusion Criteria
1. Do not resuscitate order
2. Increased intracranial pressure
3. Pregnancy (urine pregnancy test for all women of child-bearing age)
4. Planned transport out of ICU during planned study protocol
5. Coagulopathy (INR > 2.0 or PTT > 50)
6. Severe thrombocytopenia (platelets < 20,000)
7. Patients receiving medications meant to increase oxygenation such as inhaled nitric
oxide, inhaled prostacyclin, intravenous prostacyclin, and intravenous treprostinil
8. Any patient receiving a medication that is not consistent with FDA-approved labeling
9. A change in the Riker SAS during the study protocol that results in a Riker SAS score
of 1: "Unarousable" (minimal or no response to noxious stimuli, does not communicate
or follow commands) or 5: "Agitation" (anxious or physically agitated, calms to
verbal instructions) for a duration of greater than 15 minutes
10. A Riker SAS of 6: "Very agitated" (requiring restraint and frequent verbal reminding
of limits, biting ETT) or higher will result in immediate study discontinuation for
the individual participant
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