NCT01987271

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

5 months

First QC Date

November 4, 2013

Last Update Submit

November 12, 2013

Conditions

Cystic Fibrosis

Keywords

exercise toleranceexercise testnoninvasive ventilation

Outcome Measures

Primary Outcomes (1)

  • Walk Distance (WD) on six minute walk test (6MWT)

    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.

    2 days

Secondary Outcomes (5)

  • Forced expiratory volume in the first second (FEV1)

    2 days

  • Rib cage volumes

    2 days

  • Forced vital capacity (FVC)

    2 days

  • Forced expiratory flow of 25% to 75% of FVC (FEF 25-75)

    2 days

  • Respiratory cicle time

    2 days

Study Arms (2)

With noninvasive ventilation

EXPERIMENTAL

When patients do the six minute walk test with the noninvasive ventilation.

Device: Noninvasive Ventilation

Without noninvasive ventilation

NO INTERVENTION

When patients do the six minute walk test without noninvasive ventilation.

Interventions

Noninvasive VentilationDEVICE

A randomized plan define the order in which patients would execute the 6MWT, with or without NIV.

Also known as: BiLEVEL, Noninvasive ventilatory support
With noninvasive ventilation

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Medicina Intergral Prof. Fernando Fiqueira

Recife, Pernambuco, 50070-550, Brazil

Location

Related Publications (2)

  • Engelsbel S, Kuijper EJ, Dankert J, Braat MC, Egas J. [A tuberculosis project in Ecuador]. Ned Tijdschr Geneeskd. 1991 Dec 21;135(51):2428-32. Dutch.

    PMID: 1758504RESULT

  • Aliverti A, Cala SJ, Duranti R, Ferrigno G, Kenyon CM, Pedotti A, Scano G, Sliwinski P, Macklem PT, Yan S. Human respiratory muscle actions and control during exercise. J Appl Physiol (1985). 1997 Oct;83(4):1256-69. doi: 10.1152/jappl.1997.83.4.1256.

    PMID: 9338435RESULT

Related Links

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Noninvasive VentilationContinuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory TherapyPositive-Pressure Respiration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master - Universidade Federal de Pernambuco

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 19, 2013

Study Start

August 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

BR(1)