Evaluation of Lung Deposition of Aerosol Via HFNC in Healthy Adults

Healthy Clinical Trial

Official title:

Evaluation of Lung Deposition of Aerosol Via HFNC in Healthy Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02519465
• Other study ID #: Luciana doutorado 02
• Status: Recruiting
• Phase: N/A
• First received: August 6, 2015
• Last updated: August 10, 2015
• Start date: July 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Universidade Federal de Pernambuco
• Contact: Daniella C Brandao, PhD
• Phone: +558121268496
• Email: daniellacunha[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• 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
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Laboratório de Fisiologia e Fisioterapia Cardiopulmonar	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radioaerosol deposition index into the lungs		1 month	Yes