Evaluation of Lung Deposition of Aerosol Via HFNC in Healthy Adults

Study Overview
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Brief Summary
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The aerosol associated with noninvasive ventilation (NIV) and high flow therapy with nasal interface have been employed in an attempt to relieve respiratory distress and optimize the deposition of drugs by inhalation. Some studies report the effects of NIV association with fogging in healthy subjects, asthmatics and COPD 7.8, but studies evaluating the association between high flow nasal mist interface and therapy are scarce and most are found in vitro and animal models. The objective of this study is to evaluate the deposition of the aerosol scintigraphy using the high flow nasal interface system with vibrating mesh nebulizers using in healthy adults.

Official Title
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Evaluation of Lung Deposition of Aerosol Via HFNC in Healthy Adults

Conditions
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Healthy

Intervention / Treatment
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* Other: 10l/min
* Other: 30l/min
* Other: 50l/min


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The study included healthy individuals of both sexes, between 18 to 65 years, without history of lung disease and forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) higher or equal to 80% from predicted values, ability to verbal commands understand and willing to provide signed consent to participate in this study. Exclusion Criteria: Participants were excluded if there unable to understand and follow the procedures and were pregnant and unable to tolerate nebulization.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HEATED FLOW<br>The volunteers were randomly allocated into three groups - group 1 - 10l/min cold or heated, group 2 - 30l/min cold or heated, group 3 - 50 l /min - cold or heatedPhase 1 - 10l/min or 30l/min or 50l/min of the oxygen heated . | Other: 10l/min<br>* For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher & Paykel healthcare, New Zealand) and nasal cannula (Fisher & Paykel healthcare, New Zealand) with flow 10l/min<br>Other: 30l/min<br>* For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher & Paykel healthcare, New Zealand) and nasal cannula (Fisher & Paykel healthcare, New Zealand) with flow 30l/min.<br>Other: 50l/min<br>* For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher & Paykel healthcare, New Zealand) and nasal cannula (Fisher & Paykel healthcare, New Zealand) with flow 50l/min.<br>|
| Active Comparator: COLD FLOW<br>The volunteers were randomly allocated into three groups - group 1 - 10l/min cold or heated, group 2 - 30l/min cold or heated, group 3 - 50 l /min - cold or heatedPhase 1 - 10l/min or 30l/min or 50l/min of the oxygen cold | Other: 10l/min<br>* For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher & Paykel healthcare, New Zealand) and nasal cannula (Fisher & Paykel healthcare, New Zealand) with flow 10l/min<br>Other: 30l/min<br>* For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher & Paykel healthcare, New Zealand) and nasal cannula (Fisher & Paykel healthcare, New Zealand) with flow 30l/min.<br>Other: 50l/min<br>* For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher & Paykel healthcare, New Zealand) and nasal cannula (Fisher & Paykel healthcare, New Zealand) with flow 50l/min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radioaerosol deposition index into the lungs |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal cannula, Inhalation Devices