HealthyNCT01102166
Acapella With Nebulization in Normal Subjects
A study testing Acapella with nebulization in people with Healthy, run by Universidade Federal de Pernambuco.
Trial summary
Background: Devices used to facilitate mucus mobilization have been target of several controversies and mainly a few scientific studies that endorse the use of those equipments. According to the principle of acapella® device, it should be used concomitant with nebulization aiming to optimize its performance in… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Acapella with nebulization
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Performed spirometry
- According to the criteria of the Guidelines for Pulmonary Function-2002 published by the official organ of the Brazilian Society of Thoracic
Who cannot join
- Presence of pulmonary pathology;
- Neurological diseases and body temperature greater than 37 º C during the initial evaluation and during intervention
- Respiratory rate (RR) greater than 35ipm.
About this study
Official title: Effect of the Use the Acapella Device in Regional Lung Deposition of Radio-aerosol
Background:
Devices used to facilitate mucus mobilization have been target of several controversies and mainly a few scientific studies that endorse the use of those equipments. According to the principle of acapella® device, it should be used concomitant with nebulization aiming to optimize its performance in bronchial hygiene.
Read more
Aims: To assess the effect of acapella® device application in the radioaerosol regional pulmonary deposition through pulmonary scintigraphy in normal subjects.
Materials and method: 10 health individuals, males and mean age of 24,4 ± 2,2 years participated in this study during the three phases of this research: 1st phase were done with nebulization through acapella® device, attached in the final branch according to manufacturer recommendation; in 2nd phase a ¨T¨tube connector were adapted, being nebulizer attached to the mouthpiece and in 3rd phase nebulization were performance through the mouthpiece as routinely used in aerosoltherapy.
- Conditions
- Healthy
- Being tested
- Acapella with nebulization
- Keywords
- This study was conducted in healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acapella with nebulizationOther
Also called - Acapella ® device (DHD Healthcare, wampsville, New York), - Activity standardized 25mCI and after the inhalation chamber were placed on scintigraphy (FORTE of Adac Laboratories)
- st Phase In this phase the jet nebulizer was connected to the branch end of the Acapella according to manufacturer's recommendations. The volunteer did the radio-aerosol inhalation to obtain images of the lung fields scintigraphy static during the period of 300 seconds using an array of at 256x256x16 incidence later, as that encompasses most incidence of lung volume.
- nd Phase The experimental procedure of this phase was similar to the 1st stage, but what differed was it made an adjustment by placing a pipe "T" between the mouthpiece and the device Acapella so that the aerosol would be inhaled not pass through the device.
Stage 3 This stage was considered phase control since the aerosol inhalation was performed through the mouthpiece connected directly to the nebulizer as is routinely used in clinical practice as illustrated. The procedure of this phase followed the same protocol of previous phases.
What is being measured
The primary outcome is the main question the study is designed to answer.
Radioaerosol regional pulmonary deposition
For analysis of lung deposition of radio-aerosol in the different lung areas were delineated regions of interest (ROIs), one for each lung, called the right posterior and left posterior. To analyze this deposition, the lung was divided into regions: upper, middle and bottom, and peripheral, central and intermediate.
Measured: One year
Secondary outcomes (1)
Spirometric values
The procedure was performed with the nose occluded by a nose clip and spirometric data were considered the PFE,FVC and FEV1. We used the protocol of Pereira 3 maneuvers being conducted with an interval between the measurements of one minute. According to the American Thoracic Society, as a criterion for inclusion was considering a variation of less than 0.2 L between the tests and is considered the best of three values.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startAug 2005
- Primary completionMar 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102166
- Sponsor's protocol ID
- fabricio 01
- Status last verified
- Oct 2009
- First submitted
- 12 Apr 2010
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Franca EE, Dornelas de Andrade AF, Cabral G, Almeida Filho P, Silva KC, Galindo Filho VC, Marinho PE, Lemos A, Parreira VF. Nebulization associated with bi-level noninvasive ventilation: analysis of pulmonary radioaerosol deposition. Respir Med. 2006 Apr;100(4):721-8. doi: 10.1016/j.rmed.2005.07.012. Epub 2005 Aug 31.
PubMed 16139491Volsko TA, DiFiore J, Chatburn RL. Performance comparison of two oscillating positive expiratory pressure devices: Acapella versus Flutter. Respir Care. 2003 Feb;48(2):124-30.
PubMed 12556253Mesquita FO, Galindo-Filho VC, Neto JL, Galvao AM, Brandao SC, Fink JB, Dornelas-de-Andrade A. Scintigraphic assessment of radio-aerosol pulmonary deposition with the acapella positive expiratory pressure device and various nebulizer configurations. Respir Care. 2014 Mar;59(3):328-33. doi: 10.4187/respcare.02291. Epub 2013 Aug 6.
PubMed 23920214
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use the Acapella Device in Regional Lung Deposition of Radio-aerosol
- ClinicalTrials.gov ID
- NCT01102166
- Acronym / sponsor ID
- fabricio 01
- Conditions
- Healthy
- Keywords
- This study was conducted in healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Devices used to facilitate mucus mobilization have been target of several controversies and mainly a few scientific studies that endorse the use of those equipments. According to the principle of acapella® device, it should be used concomitant with nebulization aiming to optimize its performance in bronchial hygiene.
Aims: To assess the effect of acapella® device application in the radioaerosol regional pulmonary deposition through pulmonary scintigraphy in normal subjects.
Materials and method: 10 health individuals, males and mean age of 24,4 ± 2,2 years participated in this study during the three phases of this research: 1st phase were done with nebulization through acapella® device, attached in the final branch according to manufacturer recommendation; in 2nd phase a ¨T¨tube connector were adapted, being nebulizer attached to the mouthpiece and in 3rd phase nebulization were performance through the mouthpiece as routinely used in aerosoltherapy.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years
- Performed spirometry
- According to the criteria of the Guidelines for Pulmonary Function-2002 published by the official organ of the Brazilian Society of Thoracic
Key exclusion criteria (3 listed)
- Presence of pulmonary pathology;
- Neurological diseases and body temperature greater than 37 º C during the initial evaluation and during intervention
- Respiratory rate (RR) greater than 35ipm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acapella with nebulizationAlso: - Acapella ® device (DHD Healthcare, wampsville, New York), - Activity standardized 25mCI and after the inhalation chamber were placed on scintigraphy (FORTE of Adac Laboratories)1. st Phase In this phase the jet nebulizer was connected to the branch end of the Acapella according to manufacturer's recommendations. The volunteer did the radio-aerosol inhalation to obtain images of the lung fields scintigraphy static during the period of 300 seconds using an array of at 256x256x16 incidence later, as that encompasses most incidence of lung volume. 2. nd Phase The experimental procedure of this phase was similar to the 1st stage, but what differed was it made an adjustment by placing a pipe "T" between the mouthpiece and the device Acapella so that the aerosol would be inhaled not pass through the device. Stage 3 This stage was considered phase control since the aerosol inhalation was performed through the mouthpiece connected directly to the nebulizer as is routinely used in clinical practice as illustrated. The procedure of this phase followed the same protocol of previous phases. | Other | – |
Primary outcome
Radioaerosol regional pulmonary deposition
Time frame: One year
For analysis of lung deposition of radio-aerosol in the different lung areas were delineated regions of interest (ROIs), one for each lung, called the right posterior and left posterior. To analyze this deposition, the lung was divided into regions: upper, middle and bottom, and peripheral, central and intermediate.
1 secondary outcome
Spirometric values
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2010.
- Results publication: PubMed 16139491Franca EE, Dornelas de Andrade AF, Cabral G, Almeida Filho P, Silva KC, Galindo Filho VC, Marinho PE, Lemos A, Parreira VF. Nebulization associated with bi-level noninvasive ventilation: analysis of pulmonary radioaerosol deposition. Respir Med. 2006 Apr;100(4):721-8. doi: 10.1016/j.rmed.2005.07.012. Epub 2005 Aug 31.
- Results publication: PubMed 12556253Volsko TA, DiFiore J, Chatburn RL. Performance comparison of two oscillating positive expiratory pressure devices: Acapella versus Flutter. Respir Care. 2003 Feb;48(2):124-30.
- Derived from this study: PubMed 23920214Mesquita FO, Galindo-Filho VC, Neto JL, Galvao AM, Brandao SC, Fink JB, Dornelas-de-Andrade A. Scintigraphic assessment of radio-aerosol pulmonary deposition with the acapella positive expiratory pressure device and various nebulizer configurations. Respir Care. 2014 Mar;59(3):328-33. doi: 10.4187/respcare.02291. Epub 2013 Aug 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acapella with nebulization in people with Healthy, run by Universidade Federal de Pernambuco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radioaerosol regional pulmonary deposition (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01102166, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2010.