Safety Study of Inhaled Saline in Acute Lung Injury

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Inhaled Hypertonic Saline for the Treatment of Acute Lung Injury

Conditions
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Pulmonary Edema

Intervention / Treatment
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* Drug: Hypertonic Saline Aerosol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertonic Saline Aerosol<br>a single 5ml dose of 7% Saline aerosol | Drug: Hypertonic Saline Aerosol<br>* A single 5ml dose of 7% Saline aerosol<br>* Other names: Nebulized hypertonic saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Lung Injury, Mechanical Ventilation