Sickle Cell AnemiaSCANCT02565849
Study of Ventilatory Mechanics in Patients With Sickle Cell Anemia
An observational study of Sickle Cell Anemia, run by Rio de Janeiro State University.
Trial summary
The Sickle Cell Anemia (SCA) is a recessive genetic condition, monogenic, resulting in defects in the red cell structure. In the investigators' country, this disease affects about 3,000 children each year and is considered one of the most prevalent disorders among the group of existing hereditary diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Anemia
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Aug 2015
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with sickle cell anemia, type of hemoglobin SS, above 18 years of age, accompanied by the Hematology Clinic at the University Pedro Ernesto hospital and no contraindications for study participation
Who may be able to join
- Patients older than 18 years
- Typing of Hemoglobin SS
Who cannot join
- History absence of respiratory infections and hospitalized in the last three months
- Asthma , smoking, rheumatological and oncological diseases, acute pain and inability to independent ambulation
About this study
Official title: Early Detection of Changes in Ventilatory Mechanics in Patients With Sickle Cell Anemia
The Sickle Cell Anemia (SCA) is a recessive genetic condition, monogenic, resulting in defects in the red cell structure. In the investigators' country, this disease affects about 3,000 children each year and is considered one of the most prevalent disorders among the group of existing hereditary diseases.
The lungs are frequently affected in this disease by Acute Chest Syndrome (STA). Besides being the leading cause of death and the second leading cause of hospitalization in SCA, the STA is correlated with cognitive impairment frame these patients, resulting secondary Stroke vaso-occlusion of capillaries that supply the brain tissue.
Traditional tests of pulmonary function allow assess whether the person has any commitment in the respiratory system, whether obstructive, restrictive or mixed. To run these tests it is necessary that the patient understands and performs a forced expiratory maneuver to obtain reliable results. In the particular case of SCA, performing these tests it is very difficult due to the presence of cognitive impairment of varying degrees. This results in underdiagnosis of early changes in the lung parenchyma during the therapeutic window, committing the proper monitoring and treatment offered to these patients.
Read the detailed description
The aim of the present study is to observe the use of the Forced Oscillation Technique (FOT) in the detection of the alterations of the respiratory mechanical in subjects with Sickle Cell Anemia. One group of patients with Sickle Cell Anemia was compared with a volunteers group without pulmonary alterations.
The experimental phase of this research was developed from the University Hospital of the Pulmonology Department Pedro Ernesto (HUPE) and Laboratory Instrumentation Biomedical of Rio de Janeiro State University (UERJ) and was approved by the Committee for Ethics in the Hospital Survey. The Informed Consent was obtained from all volunteers and patients. The study protocol complies with the Helsinki Declaration and Resolution CNS 466/12.
Patients were recruited from the Hematology clinic of the University Hospital Pedro Ernesto. After screening of the inclusion criteria, these individuals were referred to the following tests: Respiratory Function Support and Technical by Forced Oscillations.
The Respiratory Function Test were performed in the Pulmonary Function Testing Laboratory at the University Hospital Pedro Ernesto and obeyed the standard protocol of the American Thoracic Society / European Respiratory Society (ATS / ERS).
In clinical exams with the FOT, the volunteers remained seated, his head in the neutral position and used a nose clip. They were asked to maintain a basal respiration throughout the examination period through a silicone nozzle, with cheeks sustained by the hands in order to reduce the shunt effect. The system applies sinusoidal pressure signals emitting oscillatory waves in the frequency range 4-32 Hz. The results to be considered suitable, should apre sit coherence function ≥ 0.9. Three measurements were performed for 16 seconds, with rest interval between them. Finally, to analyze the parameters measured, obtained was the average of all the results. Among the parameters evaluated the resistive and reactive parameters of the respiratory system were studied, respectively.
- Conditions
- Sickle Cell Anemia
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Recruited volunteers aged above 18 years with no history of smoking or hospitalization in the last three months without cardiac dysfunction, orthopedic or lung. | |
| Sickle Cell Anemia normal spirometry | Recruited patients aged above 18 years with no history of smoking or hospitalization in the last three months, ability to independent ambulation and spirometry tests and plethysmography with normal medical report. | |
| Sickle Cell Anemia spirometry abnormal | Recruited patients aged above 18 years with no history of smoking or hospitalization in the last three months, ability to independent ambulation and spirometry tests and plethysmography with altered medical report. |
What is being measured
The primary outcome is the main question the study is designed to answer.
spirometrics parameters of pulmonary function tests assessed by forced expiratory volume in one second (FEV1)
Measured: 1 day
spirometrics parameters of pulmonary function tests assessed by forced vital capacity (FVC)
Measured: 1 day
spirometrics parameters of pulmonary function tests assessed by ratio forced expiratory volume in one second and forced vital capacity (FEV1 / FVC)
Measured: 1 day
spirometrics parameters of pulmonary function tests assessed by FEF max (Flow Forced Expiratory maximum)
Measured: 1 day
plethysmographics parameters of pulmonary function tests assessed by Total Lung Capacity (TLC)
Measured: 1 day
plethysmographics parameters of pulmonary function tests assessed by functional residual capacity (FRC)
Measured: 1 day
plethysmographics parameters of pulmonary function tests assessed by residual volume (RV)
Measured: 1 day
plethysmographics parameters of pulmonary function tests assessed by Ratio Residual Volume and Total Lung Capacity (RV / TLC)
Measured: 1 day
plethysmographics parameters of pulmonary function tests assessed by Airway resistance (Rva)
Measured: 1 day
diffusion parameters of pulmonary function tests assessed by Diffusing Capacity Carbon monoxide (DLCO)
Measured: 1 day
diffusion parameters of pulmonary function tests assessed by VA (Volume Alveolar)
Measured: 1 day
diffusion parameters of pulmonary function tests assessed by diffusion coefficient (DLCO / VA)
Measured: 1 day
forced oscillation technique assessed by zero resistance at the intercept (R0) in cmH2O/l/s
Measured: 1 day
forced oscillation technique assessed by resistance at 4 Hz (Rrs4Hz) in cmH2O/l/s
Measured: 1 day
forced oscillation technique assessed by average resistance (Rm) in cmH2O/l/s
Measured: 1 day
reactive parameters of the forced oscillation technique assessed by mean reactance (Xm) in cmH2O/l/s is a parameter related to the inhomogeneity of the respiratory system
Measured: 1 day
reactive parameters of the forced oscillation technique of the respiratory system compliance was measured by dynamic compliance (Crs, dyn) in cmH2O
Measured: 1 day
reactive parameters of the forced oscillation technique of total mechanical loading of the respiratory system was assessed using the absolute value of the respiratory impedance (Z4Hz) in cmH2O/l/s
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startFeb 2013
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnemiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cirlene Marinho, Rio de Janeiro State University
- Investigators
- Cirlene Marinho, Principal investigator, University Hospital Pedro Ernesto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565849
- Sponsor's protocol ID
- EAF-8421
- Acronym
- SCA
- Status last verified
- Sep 2015
- First submitted
- 22 Aug 2015
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Changes in Ventilatory Mechanics in Patients With Sickle Cell Anemia
- ClinicalTrials.gov ID
- NCT02565849
- Acronym / sponsor ID
- SCA / EAF-8421
- Conditions
- Sickle Cell Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Oct 2015 (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 Sickle Cell Anemia (SCA) is a recessive genetic condition, monogenic, resulting in defects in the red cell structure. In the investigators' country, this disease affects about 3,000 children each year and is considered one of the most prevalent disorders among the group of existing hereditary diseases.
The lungs are frequently affected in this disease by Acute Chest Syndrome (STA). Besides being the leading cause of death and the second leading cause of hospitalization in SCA, the STA is correlated with cognitive impairment frame these patients, resulting secondary Stroke vaso-occlusion of capillaries that supply the brain tissue.
Traditional tests of pulmonary function allow assess whether the person has any commitment in the respiratory system, whether obstructive, restrictive or mixed. To run these tests it is necessary that the patient understands and performs a forced expiratory maneuver to obtain reliable results. In the particular case of SCA, performing these tests it is very difficult due to the presence of cognitive impairment of varying degrees. This results in underdiagnosis of early changes in the lung parenchyma during the therapeutic window, committing the proper monitoring and treatment offered to these patients.
Detailed description
The aim of the present study is to observe the use of the Forced Oscillation Technique (FOT) in the detection of the alterations of the respiratory mechanical in subjects with Sickle Cell Anemia. One group of patients with Sickle Cell Anemia was compared with a volunteers group without pulmonary alterations.
The experimental phase of this research was developed from the University Hospital of the Pulmonology Department Pedro Ernesto (HUPE) and Laboratory Instrumentation Biomedical of Rio de Janeiro State University (UERJ) and was approved by the Committee for Ethics in the Hospital Survey. The Informed Consent was obtained from all volunteers and patients. The study protocol complies with the Helsinki Declaration and Resolution CNS 466/12.
Patients were recruited from the Hematology clinic of the University Hospital Pedro Ernesto. After screening of the inclusion criteria, these individuals were referred to the following tests: Respiratory Function Support and Technical by Forced Oscillations.
The Respiratory Function Test were performed in the Pulmonary Function Testing Laboratory at the University Hospital Pedro Ernesto and obeyed the standard protocol of the American Thoracic Society / European Respiratory Society (ATS / ERS).
In clinical exams with the FOT, the volunteers remained seated, his head in the neutral position and used a nose clip. They were asked to maintain a basal respiration throughout the examination period through a silicone nozzle, with cheeks sustained by the hands in order to reduce the shunt effect. The system applies sinusoidal pressure signals emitting oscillatory waves in the frequency range 4-32 Hz. The results to be considered suitable, should apre sit coherence function ≥ 0.9. Three measurements were performed for 16 seconds, with rest interval between them. Finally, to analyze the parameters measured, obtained was the average of all the results. Among the parameters evaluated the resistive and reactive parameters of the respiratory system were studied, respectively.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Recruited volunteers aged above 18 years with no history of smoking or hospitalization in the last three months without cardiac dysfunction, orthopedic or lung. |
| Sickle Cell Anemia normal spirometry | – | –Recruited patients aged above 18 years with no history of smoking or hospitalization in the last three months, ability to independent ambulation and spirometry tests and plethysmography with normal medical report. |
| Sickle Cell Anemia spirometry abnormal | – | –Recruited patients aged above 18 years with no history of smoking or hospitalization in the last three months, ability to independent ambulation and spirometry tests and plethysmography with altered medical report. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sickle cell anemia, type of hemoglobin SS, above 18 years of age, accompanied by the Hematology Clinic at the University Pedro Ernesto hospital and no contraindications for study participation
Key inclusion criteria (2 listed)
- Patients older than 18 years
- Typing of Hemoglobin SS
Key exclusion criteria (2 listed)
- History absence of respiratory infections and hospitalized in the last three months
- Asthma , smoking, rheumatological and oncological diseases, acute pain and inability to independent ambulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
spirometrics parameters of pulmonary function tests assessed by forced expiratory volume in one second (FEV1)
Time frame: 1 day
spirometrics parameters of pulmonary function tests assessed by forced vital capacity (FVC)
Time frame: 1 day
spirometrics parameters of pulmonary function tests assessed by ratio forced expiratory volume in one second and forced vital capacity (FEV1 / FVC)
Time frame: 1 day
spirometrics parameters of pulmonary function tests assessed by FEF max (Flow Forced Expiratory maximum)
Time frame: 1 day
plethysmographics parameters of pulmonary function tests assessed by Total Lung Capacity (TLC)
Time frame: 1 day
plethysmographics parameters of pulmonary function tests assessed by functional residual capacity (FRC)
Time frame: 1 day
plethysmographics parameters of pulmonary function tests assessed by residual volume (RV)
Time frame: 1 day
plethysmographics parameters of pulmonary function tests assessed by Ratio Residual Volume and Total Lung Capacity (RV / TLC)
Time frame: 1 day
plethysmographics parameters of pulmonary function tests assessed by Airway resistance (Rva)
Time frame: 1 day
diffusion parameters of pulmonary function tests assessed by Diffusing Capacity Carbon monoxide (DLCO)
Time frame: 1 day
diffusion parameters of pulmonary function tests assessed by VA (Volume Alveolar)
Time frame: 1 day
diffusion parameters of pulmonary function tests assessed by diffusion coefficient (DLCO / VA)
Time frame: 1 day
forced oscillation technique assessed by zero resistance at the intercept (R0) in cmH2O/l/s
Time frame: 1 day
forced oscillation technique assessed by resistance at 4 Hz (Rrs4Hz) in cmH2O/l/s
Time frame: 1 day
forced oscillation technique assessed by average resistance (Rm) in cmH2O/l/s
Time frame: 1 day
reactive parameters of the forced oscillation technique assessed by mean reactance (Xm) in cmH2O/l/s is a parameter related to the inhomogeneity of the respiratory system
Time frame: 1 day
reactive parameters of the forced oscillation technique of the respiratory system compliance was measured by dynamic compliance (Crs, dyn) in cmH2O
Time frame: 1 day
reactive parameters of the forced oscillation technique of total mechanical loading of the respiratory system was assessed using the absolute value of the respiratory impedance (Z4Hz) in cmH2O/l/s
Time frame: 1 day
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 1 Oct 2015.
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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.
Cirlene Marinho principal investigator
University Hospital Pedro Ernesto
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Anemia, run by Rio de Janeiro State University.
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 2 inclusion and 2 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 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
spirometrics parameters of pulmonary function tests assessed by forced expiratory volume in one second (FEV1) (time frame: 1 day). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2015.