Open Lung Strategy, Gas Distribution and Right Heart Function in ARDS Patients

Description

The goal of this interventional crossover study, in intubated and mechanically ventilated Acute Respiratory Distress Syndrome (ARDS) patients, is to compare two positive end-expiratory pressure (PEEP) titration techniques regarding: respiratory mechanics, gas exchange, changes in aeration and distribution of ventilation and its impact on cardiac function , specially the right heart (RH). The PEEP titration techniques are : incremental PEEP titration(PEEPinc) and Lung recruitment maneuver plus incremental (LRM plus PEEPdec).

Study Start Date

October, 01 2017

Estimated Completion Date

August 2019

Interventions

  • Procedure: PEEPinc
  • Procedure: LRM plus PEEPdec

Study ID

Massachusetts General Hospital -- OLA-HEART

Status

Recruiting

Trial ID

NCT03202641

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

30

Sponsor

Massachusetts General Hospital

Inclusion Criteria

  • ARDS diagnosis within 72h after intubation
  • Severe to moderate ARDS (PaO2 / FiO2 < 200 mmHg)
  • Presence of an arterial line
  • Between 18 and 85 years old

Exclusion Criteria

  • Persistent systolic blood pressure < 90 mmHg and/or >180 mmHg despite the use of vasopressor or vasodilators
  • Increment in vasopressors over the past two hour just before enrollment of: more than 15 mcg/min for norepinephrine and dopamine, more than 10 mcg/min in epinephrine
  • and more than 50 mcg/ min for phenylephrine.
  • Advanced lung disease confirmed by computed tomography findings
  • Presence or history of pneumothorax
  • Severe coagulopathy (INR ? 4)
  • Severe thrombocytopenia (Platelets count ? 5,000/mm3)
  • Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator
  • Recent esophageal trauma or surgery
  • Known presence of esophageal varices
  • Pregnancy

Gender

All

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (4)

Study Location Distance Name Phone Email
Massachussets General Hospital - Boston, Massachusetts 2.8 miles Lorenzo Berra MD 617-643-7733 None
Massachussets General Hospital - Boston, Massachusetts 2.8 miles Lorenzo Berra MD 617-643-7733 None
Massachussets General Hospital - Boston, Massachusetts 2.8 miles Lorenzo Berra MD 617-643-7733 None
Massachussets General Hospital - Boston, Massachusetts 2.8 miles Lorenzo Berra MD 617-643-7733 None

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