Acute AsthmaNCT00922350
Heliox and Posture in Patients With Asthma
A study testing HELIOX, OXYGEN and HELIOX+POSTURE in people with Acute Asthma, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
The purpose of this study is to verify that nebulization with bronchodilators associated with heliox gas (helium + oxygen) and the posture of a leaning forward truck is effective in patients with an asthma attack. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Asthma
- What is being tested?
- HELIOX, OXYGEN and HELIOX+POSTURE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- reversibility of bronchial obstruction after administration of bronchodilator drugs for at least 10% in FEV1
- a clinical diagnosis of acute severe asthma
- a history of asthma over 1 year
- duration of the crisis of current asthma lasting less than seven days
Who cannot join
- were unable to understand or perform the spirometric maneuver
- smoking (within the last 3 years associated with a higher consumption of 100 cigarettes/year)
- other pulmonary comorbidities
- lower to upper airways
- heart failure
- heart rate greater than 150 bpm
Show all 9Show fewer
- systolic pressure below 90 mmHg or greater than 150 MHG
- pregnancy
- inability to stay inline with the trunk forward
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heliox and Posture Optimize Action of Nebulization With Bronchodilators for Asthma Attacks. Randomized Trial.
The purpose of this study is to verify that nebulization with bronchodilators associated with heliox gas (helium + oxygen) and the posture of a leaning forward truck is effective in patients with an asthma attack.
Read the detailed description
When associated with inhaled bronchodilators, the heliox, a mixture of helium and oxygen in obstructive lung diseases with asthma, reduces the turbulence of airflow despite high rates, due to its low density.
Although the first report of the use of heliox in the treatment of asthma dating to 1935, few controlled studies are available clarify the impact of the use of heliox in hospital admission of patients with acute asthma attacks refractory to standard treatment.
The severe airflow obstruction, observed in cases of acute asthma, also leads to lung hyperinflation that favors the increase of respiratory work by increasing the load for the inspiratory muscles by placing them at a mechanical disadvantage.
Various body positions were studied relating them to muscle activity with mechanical disadvantage. These studies suggest that the influence posture acts mainly in the position of the diaphragm, thus, increasing the stress related to other muscles such as the abdominals and the effect of gravity on these.
This study aims to: assess the efficiency of the positioning body associated with nebulization with bronchodilators carried by heliox during acute severe asthma in adults, using as the primary outcomes FEV1, FVC and PEF and secondary outcomes as the Borg scale, inspiratory capacity, RR, HR and SpO2.
- Conditions
- Acute Asthma
- Being tested
- HELIOX, OXYGEN, HELIOX+POSTURE, OXYGEN + POSTURE
- Keywords
- asthma, heliox, bronchodilators, posture
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HELIOXOther
Also called asma
The nebulization was conducted in the same way that heliox + posture group, except the attitude of trunk, where the patients in this group did the Nebulizer with the trunk upright.
OXYGENOther
Also called ASTHMA, NEBULIZATION
The NEBULIZATION was performed the same way as the heliox group, except for torso posture, where the patients in this group with the trunk upright Nebulizer Oxygen for cars have A NEBULIZATION.
HELIOX+POSTUREOther
Also called heliox, posture, physioterapy
Patients underwent two carried by heliox nebulization associated with fenoterol (2.5 mg) and ipratropium bromide (0.25 mg). We used three ml of saline solution at 0.9%. For nebulization with heliox or oxygen, was used a system of distribution not invasive, semi-closed in a mask that is non toxic connected to a piece "Y" with a nebulizer in a follow and a bag of tank with a capacity for 2.5 L in the other connected with a valve action. This system was used so that there was a dilution gas. The proportion of 80:20 heliox was used (80% helium: 20% oxygen). To postural change in groups and heliox Oxygen + posture + posture, oriented to the participants to maintain an angle of inclination of the trunk and elbows supported on the thighs, measured from the anterior axillary line and lateral epicondyle of the femur, between 50th and 60th .
OXYGEN + POSTUREOther
Also called POSTURE, PHYSIOTERAPY, ASTHMA
The NEBULIZATION was conducted in the same way that heliox + posture GROUP, however the patients in this group have the Oxygen for Carr A NEBULIZATION
| Study group | Role | What they receive |
|---|---|---|
| heliox | Experimental | The patients in this group underwent nebulization with heliox carried by the trunk erect Receives: Other: HELIOX |
| heliox+posture | Experimental | The patients in this group carried out the mist carried by heliox and the trunk tilted forward Receives: Other: HELIOX+POSTURE |
| oxygen+posture | Experimental | The patients in this group carried out the mist carried by oxygen and the trunk tilted forward Receives: Other: OXYGEN + POSTURE |
| oxygen | Active comparator | The patients in this group carried out the mist carried by the oxygen and the trunk upright Receives: Other: OXYGEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry
Measured: 6 months
Secondary outcomes (4)
Respiratory rate
Measured: 6 months
Peripheral oxygen saturation
Measured: 6 months
Borg scale
Measured: 6 months
Heart rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Investigators
- Armele Andrade, Study director, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922350
- Sponsor's protocol ID
- 2525
- Status last verified
- Jun 2009
- First submitted
- 8 Jun 2009
- Last updated
- 17 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kass JE, Terregino CA. The effect of heliox in acute severe asthma: a randomized controlled trial. Chest. 1999 Aug;116(2):296-300. doi: 10.1378/chest.116.2.296.
PubMed 10453854Hess DR, Fink JB, Venkataraman ST, Kim IK, Myers TR, Tano BD. The history and physics of heliox. Respir Care. 2006 Jun;51(6):608-12.
PubMed 16723037Hess 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.
PubMed 9925082Gorini M, Iandelli I, Misuri G, Bertoli F, Filippelli M, Mancini M, Duranti R, Gigliotti F, Scano G. Chest wall hyperinflation during acute bronchoconstriction in asthma. Am J Respir Crit Care Med. 1999 Sep;160(3):808-16. doi: 10.1164/ajrccm.160.3.9712088.
PubMed 10471601Brandao DC, Britto MC, Pessoa MF, de Sa RB, Alcoforado L, Matos LO, Silva TN, de Andrade AD. Heliox and forward-leaning posture improve the efficacy of nebulized bronchodilator in acute asthma: a randomized trial. Respir Care. 2011 Jul;56(7):947-52. doi: 10.4187/respcare.00963. Epub 2011 Feb 21.
PubMed 21352660
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heliox and Posture Optimize Action of Nebulization With Bronchodilators for Asthma Attacks. Randomized Trial.
- ClinicalTrials.gov ID
- NCT00922350
- Acronym / sponsor ID
- 2525
- Conditions
- Acute Asthma
- Keywords
- asthma, heliox, bronchodilators, posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to verify that nebulization with bronchodilators associated with heliox gas (helium + oxygen) and the posture of a leaning forward truck is effective in patients with an asthma attack.
Detailed description
When associated with inhaled bronchodilators, the heliox, a mixture of helium and oxygen in obstructive lung diseases with asthma, reduces the turbulence of airflow despite high rates, due to its low density.
Although the first report of the use of heliox in the treatment of asthma dating to 1935, few controlled studies are available clarify the impact of the use of heliox in hospital admission of patients with acute asthma attacks refractory to standard treatment.
The severe airflow obstruction, observed in cases of acute asthma, also leads to lung hyperinflation that favors the increase of respiratory work by increasing the load for the inspiratory muscles by placing them at a mechanical disadvantage.
Various body positions were studied relating them to muscle activity with mechanical disadvantage. These studies suggest that the influence posture acts mainly in the position of the diaphragm, thus, increasing the stress related to other muscles such as the abdominals and the effect of gravity on these.
This study aims to: assess the efficiency of the positioning body associated with nebulization with bronchodilators carried by heliox during acute severe asthma in adults, using as the primary outcomes FEV1, FVC and PEF and secondary outcomes as the Borg scale, inspiratory capacity, RR, HR and SpO2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| heliox | Experimental | Other: HELIOXThe patients in this group underwent nebulization with heliox carried by the trunk erect |
| heliox+posture | Experimental | Other: HELIOX+POSTUREThe patients in this group carried out the mist carried by heliox and the trunk tilted forward |
| oxygen+posture | Experimental | Other: OXYGEN + POSTUREThe patients in this group carried out the mist carried by oxygen and the trunk tilted forward |
| oxygen | Active comparator | Other: OXYGENThe patients in this group carried out the mist carried by the oxygen and the trunk upright |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- reversibility of bronchial obstruction after administration of bronchodilator drugs for at least 10% in FEV1
- a clinical diagnosis of acute severe asthma
- a history of asthma over 1 year
- duration of the crisis of current asthma lasting less than seven days
Key exclusion criteria (9 listed)
- were unable to understand or perform the spirometric maneuver
- smoking (within the last 3 years associated with a higher consumption of 100 cigarettes/year)
- other pulmonary comorbidities
- lower to upper airways
- heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HELIOXAlso: asmaThe nebulization was conducted in the same way that heliox + posture group, except the attitude of trunk, where the patients in this group did the Nebulizer with the trunk upright. | Other | heliox |
| OXYGENAlso: ASTHMA, NEBULIZATIONThe NEBULIZATION was performed the same way as the heliox group, except for torso posture, where the patients in this group with the trunk upright Nebulizer Oxygen for cars have A NEBULIZATION. | Other | oxygen |
| HELIOX+POSTUREAlso: heliox, posture, physioterapyPatients underwent two carried by heliox nebulization associated with fenoterol (2.5 mg) and ipratropium bromide (0.25 mg). We used three ml of saline solution at 0.9%. For nebulization with heliox or oxygen, was used a system of distribution not invasive, semi-closed in a mask that is non toxic connected to a piece "Y" with a nebulizer in a follow and a bag of tank with a capacity for 2.5 L in the other connected with a valve action. This system was used so that there was a dilution gas. The proportion of 80:20 heliox was used (80% helium: 20% oxygen). To postural change in groups and heliox Oxygen + posture + posture, oriented to the participants to maintain an angle of inclination of the trunk and elbows supported on the thighs, measured from the anterior axillary line and lateral epicondyle of the femur, between 50th and 60th . | Other | heliox+posture |
| OXYGEN + POSTUREAlso: POSTURE, PHYSIOTERAPY, ASTHMAThe NEBULIZATION was conducted in the same way that heliox + posture GROUP, however the patients in this group have the Oxygen for Carr A NEBULIZATION | Other | oxygen+posture |
Primary outcome
Spirometry
Time frame: 6 months
4 secondary outcomes
Respiratory rate
Time frame: 6 months
Peripheral oxygen saturation
Time frame: 6 months
Borg scale
Time frame: 6 months
Heart rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2009.
- Results publication: PubMed 10453854Kass JE, Terregino CA. The effect of heliox in acute severe asthma: a randomized controlled trial. Chest. 1999 Aug;116(2):296-300. doi: 10.1378/chest.116.2.296.
- Results publication: PubMed 16723037Hess DR, Fink JB, Venkataraman ST, Kim IK, Myers TR, Tano BD. The history and physics of heliox. Respir Care. 2006 Jun;51(6):608-12.
- Results publication: PubMed 9925082Hess 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 publication: PubMed 10471601Gorini M, Iandelli I, Misuri G, Bertoli F, Filippelli M, Mancini M, Duranti R, Gigliotti F, Scano G. Chest wall hyperinflation during acute bronchoconstriction in asthma. Am J Respir Crit Care Med. 1999 Sep;160(3):808-16. doi: 10.1164/ajrccm.160.3.9712088.
- Derived from this study: PubMed 21352660Brandao DC, Britto MC, Pessoa MF, de Sa RB, Alcoforado L, Matos LO, Silva TN, de Andrade AD. Heliox and forward-leaning posture improve the efficacy of nebulized bronchodilator in acute asthma: a randomized trial. Respir Care. 2011 Jul;56(7):947-52. doi: 10.4187/respcare.00963. Epub 2011 Feb 21.
- Federal University of PernambucoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armele Andrade study director
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HELIOX, OXYGEN and HELIOX+POSTURE in people with Acute Asthma, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometry (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00922350, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2009.