Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000078055
Ethics application status
Approved
Date submitted
18/01/2010
Date registered
21/01/2010
Date last updated
21/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute effect of slow expiration with the glottis open in lateral posture ("expiration lente totale glotte ouverte en infralatéral", ELTGOL) and huff on physical properties of sputum from patients with bronchiectasis: a pilot study
Scientific title
Acute effect of slow expiration with the glottis open in lateral posture ("expiration lente totale glotte ouverte en infralatéral", ELTGOL) and huff on physical properties of sputum from patients with bronchiectasis: a pilot study
Secondary ID [1] 1305 0
None
Universal Trial Number (UTN)
U1111-1113-3847
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 256575 0
pulmonary hypersecretion 256576 0
Condition category
Condition code
Respiratory 256741 256741 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 256742 256742 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients underwent two bronchial hygiene techniques, the slow expiration with the glottis open in lateral posture ("expiration lente totale glotte ouverte en infralatéral", ELTGOL) and huff. The patients were their own controls, i.e., patients were submitted to both techniques, at different times. The first technique applied was chosen randomly. After three days of washout, the second technique was applied, following the design of a crossover study.
Each technique was administered in the morning, in a single session, with an interval of three days between them (washout), i.e., the treatment period was one day and the washout period was 3 days.
The slow expiration with the glottis open in lateral posture ("expiration lente totale glotte ouverte en infralatéral", ELTGOL) was applied in the posture lateral right and lateral left. The patient was instructed to relax and exhale through the mouth using a mouthpiece. The physiotherapist did a manual traction in the region infralateral the chest, the ribs toward the line Alba. This tension originated from the functional residual capacity, ending at residual volume. The technique was 15 minutes in each hemithorax.
The huff was performed with the patient sitting in a chair with armrest and feet on the ground. The patient was instructed to make an inspiration to medium volumes followed by a forced expiration with the glottis and mouth open, holding the contraction of abdominal muscles, reaching residual volume. The technique was performed for ten minutes, going six huff per minute, interspersed with one minute of rest, resulting in a total of five series of huff.
Intervention code [1] 255840 0
Treatment: Other
Comparator / control treatment
Were compared two techniques of physical therapy: the slow expiration with the glottis open in lateral posture ("expiration lente totale glotte ouverte en infralatéral", ELTGOL) and huff. The two techniques are to bronchial hygiene. Slow expiration with the glottis open in lateral posture ("expiration lente totale glotte ouverte en infralatéral", ELTGOL) generates slow flow and huff generates higher flows.
Each one was applied in only one session at random.
The slow expiration with the glottis open in lateral posture ("expiration lente totale glotte ouverte en infralatéral", ELTGOL) was applied in the posture lateral right and lateral left. The patient was instructed to relax and exhale through the mouth using a mouthpiece. The physiotherapist did a manual traction in the region infralateral the chest, the ribs toward the line Alba. This tension originated from the functional residual capacity, ending at residual volume. The technique was 15 minutes in each hemithorax.
The huff was performed with the patient sitting in a chair with armrest and feet on the ground. The patient was instructed to make an inspiration to medium volumes followed by a forced expiration with the glottis and mouth open, holding the contraction of abdominal muscles, reaching residual volume. The technique was performed for ten minutes, going six huff per minute, interspersed with one minute of rest, resulting in a total of five series of huff.
Control group
Active

Outcomes
Primary outcome [1] 257661 0
In vitro mucociliary transport was evaluated by the frog palate. The velocity of mucociliary transport of sputum was expressed as relative velocity, which is the velocity of sputum test divided by the average velocity of frog mucus control. Each sputum sample analyzed was about 2mm. This analysis was always performed by a single researcher.
Timepoint [1] 257661 0
Regarding the collection and analysis of sputum were collected four samples of sputum, one initial (prior to the physiotherapeutic technique selected - baseline), another 0,15 and 30 minutes after termination technique.
Primary outcome [2] 257662 0
In vitro transport of the sputum by cough was studied in a simulated cough machine consists of the following characteristics: pressure 4.2 kg/cm2; opening time of solenoid valve 1s; cylindrical acrylic tube with 4mm inside diameter and 30cm comprimento. For each sputum sample (approximately 2mm) were five measures of displacement, expressed as mean. This analysis was always performed by a single researcher.
Timepoint [2] 257662 0
Regarding the collection and analysis of sputum were collected four samples of sputum, one initial (prior to the physiotherapeutic technique selected - baseline), another 0,15 and 30 minutes after termination technique.
Primary outcome [3] 257663 0
The contact angle of sputum was measured by microscope to measure the contact angle, equipped with an eyepiece and a goniometer. The contact angle measures the wettability, defined as the ability of mucus spread when placed on a solid surface.
Timepoint [3] 257663 0
Regarding the collection and analysis of sputum were collected four samples of sputum, one initial (prior to the physiotherapeutic technique selected - baseline), another 0,15 and 30 minutes after termination technique.
Secondary outcome [1] 262903 0
Nil
Timepoint [1] 262903 0
Nil

Eligibility
Key inclusion criteria
Patients with bronchiectasis, without viral or bacterial infection of the respiratory tract for at least 4 weeks, nonsmokers, with the amount of pulmonary secretions sufficient to allow analysis of sputum.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with viral or bacterial infection of the respiratory tract, smokers, with the amount of pulmonary secretions insufficient to allow analysis of sputum.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 2414 0
Brazil
State/province [1] 2414 0

Funding & Sponsors
Funding source category [1] 256330 0
Hospital
Name [1] 256330 0
Hospital das Forcas Armadas
Country [1] 256330 0
Brazil
Primary sponsor type
Hospital
Name
Hospital das Forcas Armadas
Address
Hospital das Forcas Armadas, Clinica de Pneumologia, Estrada Contorno do Bosque, s/n, Bairro: Cruzeiro Novo, Brasilia – DF, CEP: 70603-900.
Country
Brazil
Secondary sponsor category [1] 251652 0
Government body
Name [1] 251652 0
Ministerio da Defesa
Address [1] 251652 0
Esplanada dos Ministerios Bloco Q - 7 andar, sala 723. Ministerio da Defesa, Cep: 70.049-900 - Brasilia/DF
Country [1] 251652 0
Brazil
Other collaborator category [1] 1039 0
Individual
Name [1] 1039 0
Renata Claudia Zanchet
Address [1] 1039 0
Renata Claudia Zanchet. Hospital das Forcas Armadas, Clinica de Pneumologia, Estrada Contorno do Bosque, s/n, Bairro: Cruzeiro Novo, Brasilia, DF, CEP: 70603-900.
Country [1] 1039 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258411 0
Comite de Etica e Pesquisa da Universidade Catolica de Brasilia
Ethics committee address [1] 258411 0
Ethics committee country [1] 258411 0
Brazil
Date submitted for ethics approval [1] 258411 0
Approval date [1] 258411 0
Ethics approval number [1] 258411 0
078/2005

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30719 0
Address 30719 0
Country 30719 0
Phone 30719 0
Fax 30719 0
Email 30719 0
Contact person for public queries
Name 13966 0
Renata Claudia Zanchet
Address 13966 0
Renata Claudia Zanchet. Hospital das Forcas Armadas, Clinica de Pneumologia, Estrada Contorno do Bosque, s/n, Bairro: Cruzeiro Novo, Brasilia – DF, CEP: 70603-900.
Country 13966 0
Brazil
Phone 13966 0
+55 61 3966 2318
Fax 13966 0
Email 13966 0
[email protected]
Contact person for scientific queries
Name 4894 0
Renata Claudia Zanchet
Address 4894 0
Renata Claudia Zanchet. Hospital das Forcas Armadas, Clinica de Pneumologia, Estrada Contorno do Bosque, s/n, Bairro: Cruzeiro Novo, Brasilia – DF, CEP: 70603-900.
Country 4894 0
Brazil
Phone 4894 0
+55 61 3966 2318
Fax 4894 0
Email 4894 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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