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Evaluation of Lung Deposition of Aerosol Via HFNC in Healthy Adults

U

Universidade Federal de Pernambuco

Status

Unknown

Conditions

Healthy

Treatments

Other: 50l/min
Other: 10l/min
Other: 30l/min

Study type

Interventional

Funder types

Other

Identifiers

NCT02519465
Luciana doutorado 02

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

25 participants in 2 patient groups

HEATED FLOW
Active Comparator group
Description:
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 .
Treatment:
Other: 50l/min
Other: 30l/min
Other: 10l/min
COLD FLOW
Active Comparator group
Description:
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
Treatment:
Other: 50l/min
Other: 30l/min
Other: 10l/min

Trial contacts and locations

1

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Central trial contact

Armele F Dornelas de Andrade, PhD; Daniella C Brandao, PhD

Data sourced from clinicaltrials.gov

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