Different Positive Pressure Strategies in COPD Patients.

NCT03382197 | Unknown

• 1 other identifier: UFPE_FISIO_RESP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

aerosol therapy; positive pressure; electrical impedance tomography; pulmonary scintigraphy

Outcome Measures

Primary Outcomes (3)

• Change of Pulmonary Function

  Pulmonary function test performed through spirometry

  30 minutes after intervention

• 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.

  Immediately after intervention

• Change of Regional pulmonary ventilation

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

  30 minutes after intervention

Secondary Outcomes (3)

• Change of Ventilatory pattern

  30 minutes after intervention

• Change of Heart Rate

  30 minutes after intervention

• Change of Peripheral Oxygen Saturation

  Immediately and 30 minutes after intervention

Study Arms (3)

Nebulization

EXPERIMENTAL

control intervention, will only perform nebulization;

Device: Nebulization

Positive expiratory pressure valve

EXPERIMENTAL

Intervention, will perform nebulization associated with positive expiratory pressure valve in the airways (EPAP)

Device: Positive expiratory pressure valve

Nonivasive ventilation

EXPERIMENTAL

intervention, will perform nebulization associated with non-invasive ventilation Bi-level mode;

Device: Nonivasive ventilation

Interventions

Nebulization DEVICE

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.

Nebulization

Positive expiratory pressure valve DEVICE

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.

Positive expiratory pressure valve

Nonivasive ventilation DEVICE

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.

Nonivasive ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

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

Recife, Pernambuco, 50670-901, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Catarina Rattes

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Two experienced researchers will participate in the study, one being responsible for the evaluation of the outcomes (researcher 1) and the other responsible for the application of the intervention in each patient (researcher 2). The researcher 2 will receive in opaque and sealed envelopes the randomized order of the interventions of each patient, keeping them in secrecy until the end of the whole study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 22, 2017
• Study Start: January 1, 2018
• Primary Completion: March 16, 2018
• Study Completion: November 1, 2018
• Last Updated: July 31, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)