Pulmonary Edema
Conditions
Keywords
Acute Lung Injury, Mechanical Ventilation
Brief summary
To determine if an inhaled hypertonic saline solution has any effect on lung function in patients with acute respiratory distress syndrome (ARDS).
Detailed description
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.
Interventions
DRUGHypertonic Saline Aerosol
A single 5ml dose of 7% Saline aerosol
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Study participants will include consenting adult patients (age \> 18), who had been intubated and mechanically ventilated for \<72 hours and meet international consensus criteria for ARDS.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Compliance of the Respiratory System | Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Ventilator Interactions | 5 minutes before aersosol delivery, during the 15 minutes while aerosol is being delivered and 5 minutes after completion of the aerosol delivery | Fighting the ventilator may reflect irritant receptor feedback and related dyspnea and will speak to the feasibility/patient acceptance of the proposed therapy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Arterial Blood Gas Tension | Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery | Changes in oxygenation and CO2 elimination reflect changes in ventilation-perfusion distribution secondary to changes in bronchomotor tone and/or lung water. |
Outcome results
None listed