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Effects Of Noninvasive Ventilation On Functional Capacity Of Patients With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987271
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : November 19, 2013
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Cibelle Andrade Lima, Universidade Federal de Pernambuco

Brief Summary:
The purpose of this study is to evaluate the effect of noninvasive ventilation (NIV) in functional capacity of children and adolescents with cystic fibrosis.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: Noninvasive Ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects Of Noninvasive Ventilation During The Treadmill Walking Test On Cardiorespiratory System, Walk Distance, And Thoracoabdominal Kinematics Of Patients With Cystic Fibrosis: Clinical Randomized Controlled Trial.
Study Start Date : August 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: With noninvasive ventilation
When patients do the six minute walk test with the noninvasive ventilation.
Device: Noninvasive Ventilation
A randomized plan define the order in which patients would execute the 6MWT, with or without NIV.
Other Names:
  • BiLEVEL
  • Noninvasive ventilatory support

No Intervention: Without noninvasive ventilation
When patients do the six minute walk test without noninvasive ventilation.



Primary Outcome Measures :
  1. Walk Distance (WD) on six minute walk test (6MWT) [ Time Frame: 2 days ]
    Patients allocated to group 1 (G1) initiated the 6MWT without noninvasive ventilation (NIV) to subsequently perform the test with ventilatory support, since those allocated to group 2 (G2) underwent the tests in reverse order. Rest period between tests: 24 - 48 hours. At the end of the test, the walk distance on a treadmill is recorded.


Secondary Outcome Measures :
  1. Forced expiratory volume in the first second (FEV1) [ Time Frame: 2 days ]
    The patients do the walk test a twice on a week. Before and after each test, this variable is recorded.

  2. Rib cage volumes [ Time Frame: 2 days ]
    This variable is assessed by Optoeletronic Pletismography (BTS Bioengineering, Italy) before and after both tests, with and without NIV, recording the tidal volume, pulmonary rib cage volume, abdominal rib cage and abdominal volume (Vt, Vrcp Vrca, Vab).

  3. Forced vital capacity (FVC) [ Time Frame: 2 days ]
    The patients do the walk test a twice on the same week. Before and after each test, this variable is recorded.

  4. Forced expiratory flow of 25% to 75% of FVC (FEF 25-75) [ Time Frame: 2 days ]
    The patients do the walk test a twice on the same week. Before and after each test, this variable is recorded.

  5. Respiratory cicle time [ Time Frame: 2 days ]
    This following variable is assessed by Optoeletronic Pletismography (BTS Bioengineering, Italy) before and after both tests, with and without NIV, recording the respiratory rate (RR), inspiratory time (Ti), expiratory time (Te), total ventilatory cycle time (Ttot) and duty cycle, which represents the Ti/Ttot ratio.



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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of Cystic Fibrosis
  • FEV1< 80% of predicted
  • age between 7 and 16 years
  • clinically stable patients
  • no history of hospitalization for respiratory failure in the last three months

Exclusion Criteria:

  • recent history of hemoptysis
  • pneumothorax or evidence of emphysomatous bubbles detected by chest X-ray
  • Burkholderia cepacia colonization
  • the need for more than two physiotherapy sessions per day
  • gastroesophageal reflux
  • orthopedic trauma or cardiovascular conditions that impede the treadmill walk test
  • heart failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987271


Locations
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Brazil
Instituto de Medicina Intergral Prof. Fernando Fiqueira
Recife, Pernambuco, Brazil, 50070-550
Sponsors and Collaborators
Universidade Federal de Pernambuco
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Additional Information:
Publications of Results:
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Responsible Party: Cibelle Andrade Lima, Master - Universidade Federal de Pernambuco, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT01987271    
Other Study ID Numbers: 0.381.0.172.099-11
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013
Keywords provided by Cibelle Andrade Lima, Universidade Federal de Pernambuco:
exercise tolerance
exercise test
noninvasive ventilation
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases