Use of Heliox Associated With PEEP in Patients With Asthma
Primary Purpose
Asthma, Helium, Oxygen
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Heliox+PEP
Oxygen+PEP
Heliox
Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility 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.
Sites / Locations
- Hospital das Clínicas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Heliox + PEP (Group 1)
Oxygen+PEP(Group 2)
Heliox ( Group 3)
Oxygen (Group 4)
Arm Description
Outcomes
Primary Outcome Measures
Pulmonary deposition radioaerosol
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
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.
Full Information
NCT ID
NCT01268462
First Posted
December 29, 2010
Last Updated
December 29, 2010
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT01268462
Brief Title
Use of Heliox Associated With PEEP in Patients With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Helium, Oxygen, Positive End-Expiratory Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heliox + PEP (Group 1)
Arm Type
Experimental
Arm Title
Oxygen+PEP(Group 2)
Arm Type
Experimental
Arm Title
Heliox ( Group 3)
Arm Type
Experimental
Arm Title
Oxygen (Group 4)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Heliox+PEP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Oxygen+PEP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Heliox
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Oxygen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary deposition radioaerosol
Description
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%.
Time Frame
6 mouths
Secondary Outcome Measure Information:
Title
Pulmonary Function
Description
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.
Time Frame
The patient was the pulmonary function test before and after intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital das Clínicas
City
Recife
State/Province
Pernambuco
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
12793914
Citation
Piva JP, Menna Barreto SS, Zelmanovitz F, Amantea S, Cox P. Heliox versus oxygen for nebulized aerosol therapy in children with lower airway obstruction. Pediatr Crit Care Med. 2002 Jan;3(1):6-10. doi: 10.1097/00130478-200201000-00002.
Results Reference
result
PubMed Identifier
9925082
Citation
Hess DR, Acosta FL, Ritz RH, Kacmarek RM, Camargo CA Jr. The effect of heliox on nebulizer function using a beta-agonist bronchodilator. Chest. 1999 Jan;115(1):184-9. doi: 10.1378/chest.115.1.184.
Results Reference
result
PubMed Identifier
23664767
Citation
Alcoforado L, Brandao S, Rattes C, Brandao D, Lima V, Ferreira Lima G, Fink JB, Dornelas de Andrade A. Evaluation of lung function and deposition of aerosolized bronchodilators carried by heliox associated with positive expiratory pressure in stable asthmatics: a randomized clinical trial. Respir Med. 2013 Aug;107(8):1178-85. doi: 10.1016/j.rmed.2013.03.020. Epub 2013 May 9.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed
Description
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Use of Heliox Associated With PEEP in Patients With Asthma
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