Different Positive Pressure Strategies in COPD Patients.

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Nebulization; Device: Positive expiratory pressure valve; Device: Nonivasive ventilation

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50670-901
      • Department of Physical Therapy, Federal University of Pernambuco, Recife, Pernambuco, Brazil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Ventilatory pattern	Respiratory rate, tidal volume, minute volume, inspiratory time, expiratory time, and total time.	30 minutes after intervention
Change of Heart Rate	Heart Rate	30 minutes after intervention
Change of Peripheral Oxygen Saturation	Peripheral Oxygen Saturation	Immediately and 30 minutes after intervention

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco
• Investigators: Principal Investigator: Catarina Rattes, Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): March 16, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: electrical impedance tomography; pulmonary scintigraphy; aerosol therapy; positive pressure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: UFPE_FISIO_RESP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No