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Clinical Trials/NCT01943890
NCT01943890
Completed
Not Applicable

Establishment and Implementation of Nebulised High Volumes of Hypertonic Saline in Cystic Fibrosis Patients

Haukeland University Hospital1 site in 1 country8 target enrollmentFebruary 2010
ConditionsCystic Fibrosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystic Fibrosis
Sponsor
Haukeland University Hospital
Enrollment
8
Locations
1
Primary Endpoint
Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Background Nebulised hypertonic saline (HS) is an established basic airway clearance treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical implementation and administration of different HS volumes, including physiotherapy and aspects of breathing pattern.

The aim of the study was to implement standardised and age-adjusted nebulised volumes of hypertonic saline in cystic fibrosis patients, included in physiotherapy and lung drainage techniques.

Detailed Description

Aims: To establish a safe, efficient routine for implementation of HS in daily treatment and to investigate the efficiency and tolerance of high volumes of HS integrated with chest physiotherapy. HS was given twice daily with volumes of 4,5 ml in children aged 0-5 years, 6 ml at age 6-16 years and 9 ml at age \> 16 years. The protocol included guidance of standardized breathing pattern, upright and sideways positioning and voluntary cough.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
December 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Haukeland University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Cystic fibrosis

Exclusion Criteria

  • Non-adherence

Outcomes

Primary Outcomes

Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second

Time Frame: 24 months

Secondary Outcomes

  • Implementation of nebulised high volumes of hypertonic saline in cystic fibrosis patients(24 months)

Study Sites (1)

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