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To determine if an inhaled hypertonic saline solution has any effect on lung function in patients with acute respiratory distress syndrome (ARDS).
Hypertonic Saline (HS) aerosols have proven efficacious mucolytics in patient with cystic fibrosis and are well tolerated in that population. Safety concerns in mechanically ventilated patients with ARDS center primarily on HS's effects on lung water distribution (intra vs. extra alveolar) and on airway reactivity. For that reason we plan a small feasibility trial with narrowly focused physiologic endpoints, namely to measure the effects of a single 5ml dose of 7% Saline aerosol on blood gas tensions, hemodynamics and the static and dynamic properties of the relaxed respiratory system. This narrowly scoped study is to lay the foundation for a larger multicenter intervention trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertonic Saline Aerosol | Experimental | a single 5ml dose of 7% Saline aerosol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic Saline Aerosol | Drug | A single 5ml dose of 7% Saline aerosol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic Compliance of the Respiratory System | Changes in the static and dynamic properties of the respiratory system are surrogate markers of a change in airway tone and/or of the amount and distribution of alveolar edema | Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Ventilator Interactions | "Fighting" the ventilator may reflect irritant receptor feedback and related dyspnea and will speak to the feasibility/patient acceptance of the proposed therapy | 5 minutes before aersosol delivery, during the 15 minutes while aerosol is being delivered and 5 minutes after completion of the aerosol delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Blood Gas Tension | Changes in oxygenation and CO2 elimination reflect changes in ventilation-perfusion distribution secondary to changes in bronchomotor tone and/or lung water. | Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard A Oeckler, M.D., Ph.D. | Mayo Clinic | Principal Investigator |
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| ID | Term |
|---|---|
| D011654 | Pulmonary Edema |
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D055370 | Lung Injury |
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