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Study of Ventilatory Mechanics in Patients With Sickle Cell Anemia (SCA)

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ClinicalTrials.gov Identifier: NCT02565849
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
Cirlene Marinho, Rio de Janeiro State University

Tracking Information
First Submitted Date August 22, 2015
First Posted Date October 1, 2015
Last Update Posted Date October 1, 2015
Study Start Date February 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 30, 2015)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Ventilatory Mechanics in Patients With Sickle Cell Anemia
Official Title Early Detection of Changes in Ventilatory Mechanics in Patients With Sickle Cell Anemia
Brief 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.

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 Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
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
Condition Sickle Cell Anemia
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 30, 2015)
80
Original Actual Enrollment Same as current
Actual Study Completion Date August 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients older than 18 years
  • Typing of Hemoglobin SS

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02565849
Other Study ID Numbers EAF-8421
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cirlene Marinho, Rio de Janeiro State University
Study Sponsor Rio de Janeiro State University
Collaborators Not Provided
Investigators
Principal Investigator: Cirlene Marinho University Hospital Pedro Ernesto
PRS Account Rio de Janeiro State University
Verification Date September 2015