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Chronic Obstructive Pulmonary DiseaseNCT03382197

Different Positive Pressure Strategies in COPD Patients.

A study testing Nebulization, Positive expiratory pressure valve and Nonivasive ventilation in people with Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Pernambuco at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Chronic obstructive pulmonary disease (COPD) is characterized by a poorly reversible airway obstruction and consequent systemic manifestations. Its high prevalence and high number of diagnosed patients has become a challenge for health services due to the costs of diagnosis and treatment of these patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Nebulization, Positive expiratory pressure valve and Nonivasive ventilation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteBrazil
Study dates
1 Jan 2018to Nov 2018
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with stage II (moderate) and III (severe) COPD according to the guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD)

Who cannot join

  • unable to understand or perform procedures that present rheumatic or orthopedic diseases or deformities / abnormalities in the spine that compromise the mechanics of the respiratory system; respiratory comorbidities such as asthma, bronchiectasis and sequela of tuberculosis, cardiovascular and neurological comorbidities; hemodynamic instability defined as heart rate greater than 150 bpm, or systolic pressure less than 90 mmHg; hypertension (blood pressure> 149/89 mmHg) or hypotension (blood pressure <90/60 mmHg) at the time of collection; pregnancy or suspected pregnancy; and any contraindications for the use of PEP.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Department of Physical Therapy, Federal University of Pernambuco, Recife, Pernambuco, Brazil

    Recife, Pernambuco, 50670-901

Other trials in Brazil

About this study

Official title: Regional Ventilation and Radioaerosol Pulmonary Deposition Through Different Positive Pressure Strategies in COPD Patients.

Chronic obstructive pulmonary disease (COPD) is characterized by a poorly reversible airway obstruction and consequent systemic manifestations. Its high prevalence and high number of diagnosed patients has become a challenge for health services due to the costs of diagnosis and treatment of these patients. Positive pressure and aerosol therapy are preferred therapies for the management of COPD symptoms, but their effects when associated are poorly studied. The objective of this study is to compare the effects of different positive pressure strategies associated with aerosol therapy through Pulmonary Scintigraphy and Electrical Impedance Tomography (EIT) in patients with COPD in the intercrise period. This is a randomized, crossover, blinded and allocated crossover type clinical trial in which patients with moderate to severe COPD will be allocated to three intervention groups with different strategies for positive pressure associated with aerosol therapy: control group 1 nebulization), group 2 nebulization with EPAP valve and group 3 nebulization with NIV bi-level pressure mode. The radioaerosol deposition pattern will be evaluated through Pulmonary Scintigraphy and regional pulmonary ventilation through EIT.

Being tested
Nebulization, Positive expiratory pressure valve, Nonivasive ventilation
Keywords
aerosol therapy, positive pressure, electrical impedance tomography, pulmonary scintigraphy
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NebulizationDevice

    For inhalation of the radioaerosol a dose of DTPA-Tc99m (methionine-labeled diethylnitriaminepentaacetic acid) with 1mCi activity, associated with 10 drops of Fenoterol Bromide and 20 drops of Ipatropium Bromide diluted for a total of up to 3 ml of saline solution 0.9%. A MESH vibrating nebulizer (NIVO, Philips Respironics, Murrysville, Pennsylvania) will be used.

  • Positive expiratory pressure valveDevice

    For nebulization associated with the EPAP valve will be used a non-invasive distribution system consisting of a non-toxic orofacial mask connected to a spring loaded EPAP valve. This mask will be secured to the patient's face through tabs in order to prevent leakage and to maintain proper pressurizing and better patient adaptation.

  • Nonivasive ventilationDevice

    For nebulization associated with NIV, a noninvasive distribution system consisting of a non-toxic orofacial mask connected to the NIV circuit will be used, and the latter will be being fed by a radioaerosol flow generated by a nebulizer coupled to the circuit. This mask will be secured to the patient's face through tabs in order to prevent leakage and to maintain proper pressurizing and better patient adaptation.

Study groups in NCT03382197
Study groupRoleWhat they receive
NebulizationExperimentalcontrol intervention, will only perform nebulization;
Receives: Device: Nebulization
Positive expiratory pressure valveExperimentalIntervention, will perform nebulization associated with positive expiratory pressure valve in the airways (EPAP)
Receives: Device: Positive expiratory pressure valve
Nonivasive ventilationExperimentalintervention, will perform nebulization associated with non-invasive ventilation Bi-level mode;
Receives: Device: Nonivasive ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Pulmonary Function

    Pulmonary function test performed through spirometry

    Measured: 30 minutes after intervention

  2. Change of Aerosol deposition in the lungs

    The pulmonary deposition index (PPI), expressed in percentage terms and obtained by the ratio of the number of counts of each ROI to the total number of counts of the respective lung.

    Measured: Immediately after intervention

  3. Change of Regional pulmonary ventilation

    The impedance variation (AZ) and regional pulmonary ventilation (ZEE) will be evaluated for each region of interest.

    Measured: 30 minutes after intervention

Secondary outcomes (3)

  1. Change of Ventilatory pattern

    Respiratory rate, tidal volume, minute volume, inspiratory time, expiratory time, and total time.

    Measured: 30 minutes after intervention

  2. Change of Heart Rate

    Heart Rate

    Measured: 30 minutes after intervention

  3. Change of Peripheral Oxygen Saturation

    Peripheral Oxygen Saturation

    Measured: Immediately and 30 minutes after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2017
  2. Study start1 Jan 2018
  3. Primary completion16 Mar 2018
  4. Study completionNov 2018 (estimated)

Resources

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
Allocation
Randomised
Intervention model
Crossover
Model description
Patients will be randomized regarding the order of intervention they will receive: Group 1 - control intervention, will only perform nebulization; Group 2 - intervention, will perform nebulization associated with positive expiratory pressure valve in the airways (EPAP); Group 3 - intervention, will perform nebulization associated with non-invasive ventilation Bi-level mode; All patients will be evaluated BEFORE, DURING and AFTER each intervention through Electrical Impedance Tomography, Pulmonary Scintigraphy and Spirometry.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03382197
Sponsor's protocol ID
UFPE_FISIO_RESP
Status last verified
Jul 2018
First submitted
6 Dec 2017
Last updated
31 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nebulization, Positive expiratory pressure valve and Nonivasive ventilation in people with Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Pernambuco at 1 site in Brazil.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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?

Change of Pulmonary Function (time frame: 30 minutes after intervention). The study lists 3 primary outcomes in all. 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 NCT03382197.

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 31 Jul 2018.

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