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Evaluation of Lung Deposition of Aerosol Via HFNC in Healthy Adults

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ClinicalTrials.gov Identifier: NCT02519465
Recruitment Status : Unknown
Verified August 2015 by Daniella Cunha Brandao, Universidade Federal de Pernambuco.
Recruitment status was:  Recruiting
First Posted : August 11, 2015
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Daniella Cunha Brandao, Universidade Federal de Pernambuco

Brief 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.


Condition or disease Intervention/treatment Phase
Healthy Other: 10l/min Other: 30l/min Other: 50l/min Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Lung Deposition of Aerosol Via HFNC in Healthy Adults
Study Start Date : July 2015
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Arm Intervention/treatment
Active Comparator: 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 .
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

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.

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.

Active Comparator: 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
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

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.

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.




Primary Outcome Measures :
  1. radioaerosol deposition index into the lungs [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519465


Contacts
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Contact: Daniella C Brandao, PhD +558121268496 daniellacunha@hotmail.com
Contact: Armele F Dornelas de Andrade, PhD +558121268496 armeledornelas@yahoo.com

Locations
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Brazil
Laboratório de Fisiologia e Fisioterapia Cardiopulmonar Recruiting
Recife, Pernambuco, Brazil
Contact: Luciana Alcoforado       lucalcoforado@yahoo.com.br   
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
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Principal Investigator: Luciana Alcoforado, MsC UFPE
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniella Cunha Brandao, Luciana Alcoforado Mendes da Silva, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02519465    
Other Study ID Numbers: Luciana doutorado 02
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015
Keywords provided by Daniella Cunha Brandao, Universidade Federal de Pernambuco:
nasal cannula
Inhalation Devices