Use of Heliox Associated With PEEP in Patients With Asthma

This study has been completed.
Sponsor:
Information provided by:
Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT01268462
First received: December 29, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

In patients with obstructive lung disease like asthma aerosol therapy is the most used for drug administration. A order to make better use of aerosolized drugs in asthmatic patients, studies focus on ways to optimize this administration. Objective: To evaluate the efficacy of nebulized bronchodilators carried by heliox associated with positive expiratory pressure (PEP) in lung deposition of radiation activity in adult asthmatic patients between episodes and its impact on lung function. Methods: A randomized controlled trial involving 32 with a mean age of 47.28 ± 9.67 of which 25% of the sample are male, these patients were divided into four groups: heliox + PEP, + PEP oxygen, heliox and oxygen in Regarding the anthropometric characteristics, parameters and cardiopulmonary baseline spirometry data were similar for all groups. For inhalation lung scintigraphy was used a noninvasive delivery system - orofacial mask with two unidirectional valves nontoxic - inspiratory and expiratory branch - connected to the nebulizer for radioisotopes associated with PEP of 10 cm H2O. At the end of inhalation, the images were acquired in a scintillation camera at 0, 15, 30, 45 and 60 min. In order to analyze the aerosol deposition in different lung areas were delineated regions of interest (ROIs) in the vertical - the upper, middle and bottom - and horizontal central, intermediate and peripheral. Results: The spirometric data showed an increase in the values of forced expiratory volume in one second (FEV1) predicted when compared with the heliox group + PEP (80%, p = 0.030) with PEP + O2 (65%, p = 0.030). As for CI, there was also an increase in PEP + heliox group (0.05 L, p = 0.012) compared to groups without oxygen and heliox PEP (0.03 L, 0.03 L, p = 0.012 respectively) for the total number of counts, no differences were seen between groups with heliox and oxygen with PEP PEP (482510, 577598, p = 0.262 respectively) for the total number of counts by comparing the oxygen group + PEP (577,598) with the heliox group (332,951, p = 0.004) and oxygen without PEP (409,526, p = 0.045), there was a greater number of counts in the O2 + PEP group. By analyzing the rate of pulmonary deposition (IDP) in the vertical gradient, higher deposition in the middle third (p = 0.001) when compared to upper and lower in both groups. With regard to IDPs in the horizontal gradient, there was greater deposition in the intermediate region when compared to central and peripheral (p = 0.003, 0.001 respectively) in all groups. As the penetration rate, no significant differences between groups (p = 0.726). When considering the pulmonary clearance, decreased with the number of counts over time within groups (p <0.05) but no differences between them: heliox + PEP (20.67%), PEP + oxygen (13.50%), heliox (16.27%) and oxygen (16%) - (p> 0.05). Conclusion: Although no differences in the rate of penetration and clearance of pulmonary radiation activity between groups, we noted a higher number of counts in patients who underwent nebulization with oxygen associated with PEP and a functional improvement in patients who underwent nebulization with PEP as spirometric values and CI.


Condition Intervention
Asthma
Helium
Oxygen
Positive End-Expiratory Pressure
Other: Heliox+PEP
Other: Oxygen+PEP
Other: Heliox
Other: Oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

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Further study details as provided by Universidade Federal de Pernambuco:

Primary Outcome Measures:
  • Pulmonary deposition radioaerosol [ Time Frame: 6 mouths ] [ Designated as safety issue: Yes ]
    For inhalation lung scintigraphy, was administered an average dose of acid dietilnotriaminopentaacético labeled with Technetium (DTPA - 99mTc) from 25 to 10 mCi associated bromide drops and 20 drops of Fenoterol bromide ipatropium diluted to a total of up to 3 ml saline 0.9%.


Secondary Outcome Measures:
  • Pulmonary Function [ Time Frame: The patient was the pulmonary function test before and after intervention. ] [ Designated as safety issue: Yes ]
    To obtain spirometric values and CI were asked the patients to perform three maneuvers. Spirometry were analyzed FEV1, PEF and forced vital capacity (FVC), considering the percentage of predicted as the best value recorded in accordance with American Thoracic Society. For CI, this correction was performed by body mass index (BMI) and weight.


Enrollment: 32
Study Start Date: July 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Heliox + PEP (Group 1) Other: Heliox+PEP
For the nebulization with heliox was used radioaerosol a noninvasive delivery system that consists of a nontoxic orofacial mask with two unidirectional valves - inspiratory and expiratory branch - connected to the nebulizer for radioisotopes Venticis ® II Medical device, class II, CE 0459 (Ventibox / CIS Bio International, France). This mask was attached to the patient's face to prevent leaks and maintain proper pressurization and better patient compliance to the PEP. PEP was offered to 10 cm H2O through valve (Vital Signs, Totowa, NY) attached to the expiratory branch. The nebulizer was fed by a flow of 11 l / min of heliox for the heliox group according to the protocol of Hess et al. When powered by heliox mixture, the flow was adjusted flowmeter suitable for this mixture.
Experimental: Oxygen+PEP(Group 2) Other: Oxygen+PEP
For nebulization of radioaerosol with oxygen, we used a noninvasive delivery system that consists of a mask with two nontoxic orofacial unidirectional valves - inspiratory and expiratory branch - connected to the nebulizer for radioisotopes Venticis ® II Medical device, class II, CE 0459 (Ventibox / CIS Bio International, France). This mask was attached to the patient's face to prevent leaks and maintain proper pressurization and better patient compliance to PEP (Figure 2). PEP was offered to 10 cm H2O through valve (Vital Signs, Totowa, NY) attached to the expiratory branch. The nebulizer was fed by a stream of 8 l / min oxygen.
Experimental: Heliox ( Group 3) Other: Heliox
For the nebulization with heliox we used a noninvasive delivery system that consists of a nontoxic orofacial mask with two unidirectional valves - inspiratory and expiratory branch - connected to the nebulizer for radioisotopes Venticis ® II Medical device, class II, CE 0459 (Ventibox / CIS Bio International, France). We used a PEP valve without resistance.
Active Comparator: Oxygen (Group 4) Other: Oxygen
For nebulization of radioaerosol with oxygen, we used a noninvasive delivery system that consists of a mask with two nontoxic orofacial unidirectional valves - inspiratory and expiratory branch - connected to the nebulizer for radioisotopes Venticis ® II Medical device, class II, CE 0459 (Ventibox / CIS Bio International, France). We used a PEP valve without resistance.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with clinical diagnosis of persistent asthma
  • FEV1 <60% predicted more than one year
  • Reversibility of bronchial obstruction after administration of bronchodilators at least 10% in FEV1 on spirometry.

Exclusion Criteria:

  • patients unable to understand or perform the spirometric maneuver or failed to keep in proper positioning to obtain the scintigraphic images
  • History of smoking over the past three years associated with a consumption greater than 100 cigarettes per year or who had history of smoking increased 10 years
  • pulmonary comorbidities such as COPD, bronchiectasis and tuberculosis sequelae
  • Pregnancy and any contraindication to the use of PEP, such as active hemoptysis, sinusitis, surgery or facial trauma, oral or injury, epistaxis, esophageal surgery and nausea.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01268462

Locations
Brazil
Hospital das Clínicas
Recife, Pernambuco, Brazil
Sponsors and Collaborators
Universidade Federal de Pernambuco
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Armele de Fátima Dornelas de Andrade, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT01268462     History of Changes
Other Study ID Numbers: 31012010
Study First Received: December 29, 2010
Last Updated: December 29, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014