Evaluation of Lung Deposition of Aerosol Via HFNC in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-08-31

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HEATED FLOW

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 .

Group Type ACTIVE_COMPARATOR

10l/min

Intervention Type OTHER

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

30l/min

Intervention Type OTHER

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.

50l/min

Intervention Type OTHER

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.

COLD FLOW

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

Group Type ACTIVE_COMPARATOR

10l/min

Intervention Type OTHER

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

30l/min

Intervention Type OTHER

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.

50l/min

Intervention Type OTHER

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.

Interventions

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10l/min

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

Intervention Type OTHER

30l/min

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.

Intervention Type OTHER

50l/min

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.

Intervention Type OTHER

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.