A Phase 1 interventional study of Hypertonic Saline Aerosol in Pulmonary Edema, sponsored by Mayo Clinic. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-17.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment
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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Inclusion Criteria:
a single 5ml dose of 7% Saline aerosol
Drug: Hypertonic Saline Aerosol
A single 5ml dose of 7% Saline aerosol
Also known as: Nebulized hypertonic saline
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
Time frame: Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery
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
Time frame: 5 minutes before aersosol delivery, during the 15 minutes while aerosol is being delivered and 5 minutes after completion of the aerosol delivery
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.
Time frame: Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery
No study locations are listed for this record.
This study is withdrawn, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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