Non-invasive Fluid Management

Status unconfirmed · Not applicable

Conditions studied: Respiratory Distress Syndrome, Adult

In brief

For patients with a condition called acute respiratory distress syndrome (ARDS), managing their fluid levels to achieve a negative balance helps to improve their outcomes. In the past, patients' fluid levels were monitored with central lines placed into the bloodstream. However, most patients are now managed without central lines. A device called a NICOM (noninvasive cardiac output monitor) which monitors patients' heart function, using a few patches which are attached to their chest, may be useful in managing fluid levels without central lines. This study will compare the fluid balance in patients who are managed with typical care to the fluid balance in patients who are managed with the NICOM device.

Key facts

Study ID

NCT02892799

Run by

Intermountain Health Care, Inc.

People needed

100

Starts

2015-11-12

Expected to finish

2020-12-01

Last updated by the study team

2019-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years of age
• Acute respiratory failure (must meet ONE of the following)
• Receipt of mechanical ventilation
• Receipt of non-invasive ventilation via BIPAP or CPAP, used for an indication other than sleep apnea
• Receipt of high flow nasal cannula oxygenation with FiO2 > .4 and a flow rate > 30 LPM
• Increased total body fluid volume (any of the following)
• > 1 kg increased weight gain (compared to admission)
• > 1 L positive fluid balance (compared to admission)
• Bedside clinician determination

You may not qualify if…

• Known pregnancy (a negative pregnancy test is required for women of child-bearing potential)
• Dialysis dependence, at the time of enrollment
• Chronic ventilator dependence, prior to admission
• Intubation for airway protection (solely for a surgical procedure) or upper airway obstruction
• Neuromuscular disease that impairs the ability to ventilate spontaneously, such as C5 or higher spinal cord injury, amyotrophic lateral sclerosis, Guillain-Barré Syndrome, and myasthenia gravis
• Solid organ transplantation or bone marrow transplantation
• Vasculitis with diffuse alveolar hemorrhage
• Severe chronic liver disease (Child-Pugh Score 10-15)

Where it is running

• Intermountain Medical Center — Murray, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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