NCT02519465

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

1 month

First QC Date

August 6, 2015

Last Update Submit

August 10, 2015

Conditions

Healthy

Keywords

nasal cannulaInhalation Devices

Outcome Measures

Primary Outcomes (1)

  • radioaerosol deposition index into the lungs

    1 month

Study Arms (2)

HEATED FLOW

ACTIVE COMPARATOR

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/minOther: 30l/minOther: 50l/min

COLD FLOW

ACTIVE COMPARATOR

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/minOther: 30l/minOther: 50l/min

Interventions

10l/minOTHER

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

COLD FLOWHEATED FLOW
30l/minOTHER

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.

COLD FLOWHEATED FLOW
50l/minOTHER

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 FLOWHEATED FLOW

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants were excluded if there unable to understand and follow the procedures and were pregnant and unable to tolerate nebulization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratório de Fisiologia e Fisioterapia Cardiopulmonar

Recife, Pernambuco, Brazil

RECRUITING

Related Publications (1)

  • Alcoforado L, Ari A, Barcelar JM, Brandao SCS, Fink JB, de Andrade AD. Impact of Gas Flow and Humidity on Trans-Nasal Aerosol Deposition via Nasal Cannula in Adults: A Randomized Cross-Over Study. Pharmaceutics. 2019 Jul 7;11(7):320. doi: 10.3390/pharmaceutics11070320.

    PMID: 31284680DERIVED

Study Officials

  • Luciana Alcoforado, MsC

    UFPE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniella C Brandao, PhD

CONTACT

+558121268496daniellacunha@hotmail.com

Armele F Dornelas de Andrade, PhD

CONTACT

+558121268496armeledornelas@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Luciana Alcoforado Mendes da Silva

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 11, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations

BR(1)