Different Positive Pressure Strategies in COPD Patients.

Sponsor

Universidade Federal de Pernambuco (Other)

Overall Status

Unknown status

CT.gov ID

NCT03382197

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Device: Nebulization Device: Positive expiratory pressure valve Device: Nonivasive ventilation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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 (Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Mar 16, 2018

Anticipated Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nebulization control intervention, will only perform nebulization;	Device: Nebulization 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.
Experimental: Positive expiratory pressure valve Intervention, will perform nebulization associated with positive expiratory pressure valve in the airways (EPAP)	Device: Positive expiratory pressure valve 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.
Experimental: Nonivasive ventilation intervention, will perform nebulization associated with non-invasive ventilation Bi-level mode;	Device: Nonivasive ventilation 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.

Arm

Intervention/Treatment

Experimental: Nebulization

control intervention, will only perform nebulization;

Device: Nebulization

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.

Experimental: Positive expiratory pressure valve

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

Device: Positive expiratory pressure valve

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.

Experimental: Nonivasive ventilation

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

Device: Nonivasive ventilation

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.

Outcome Measures

Primary Outcome Measures

Change of Pulmonary Function [30 minutes after intervention]
Pulmonary function test performed through spirometry
Change of Aerosol deposition in the lungs [Immediately after intervention]
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.
Change of Regional pulmonary ventilation [30 minutes after intervention]
The impedance variation (AZ) and regional pulmonary ventilation (ZEE) will be evaluated for each region of interest.

Secondary Outcome Measures

Change of Ventilatory pattern [30 minutes after intervention]
Respiratory rate, tidal volume, minute volume, inspiratory time, expiratory time, and total time.
Change of Heart Rate [30 minutes after intervention]
Heart Rate
Change of Peripheral Oxygen Saturation [Immediately and 30 minutes after intervention]
Peripheral Oxygen Saturation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.