Back to resultsHigh Volumes of Hypertonic Saline and Chest Physiotherapy in CF Patients
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Hypertonic saline
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Hypertonic saline, Lung physiotherapy
Eligibility Criteria
Inclusion Criteria:
- Cystic fibrosis
Exclusion Criteria:
- Non-adherence
Sites / Locations
- Dept. of Thoracic Medicine, Haukeland University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physiotherapy and hypertonic saline
Arm Description
Chest physiotherapy integrated with inhalation of hypertonic saline
Outcomes
Primary Outcome Measures
Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second
Secondary Outcome Measures
Implementation of nebulised high volumes of hypertonic saline in cystic fibrosis patients
Establishment of a standardized routine of nebulised high volumes of hypertonic saline including chest physiotherapy in cystic fibrosis patients
Full Information
NCT ID
NCT01943890
First Posted
May 16, 2012
Last Updated
September 16, 2013
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01943890
Brief Title
High Volumes of Hypertonic Saline and Chest Physiotherapy in CF Patients
Official Title
Establishment and Implementation of Nebulised High Volumes of Hypertonic Saline in Cystic Fibrosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Hypertonic saline, Lung physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy and hypertonic saline
Arm Type
Experimental
Arm Description
Chest physiotherapy integrated with inhalation of hypertonic saline
Intervention Type
Device
Intervention Name(s)
Hypertonic saline
Intervention Description
1 mmol/ml hypertonic saline given from (small children) 1,5 ml in 3 positions twice daily increasing to (children) 2 ml in 3 positions twice daily and up to (adults) 3 ml in 3 positions twice daily
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy
Primary Outcome Measure Information:
Title
Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Implementation of nebulised high volumes of hypertonic saline in cystic fibrosis patients
Description
Establishment of a standardized routine of nebulised high volumes of hypertonic saline including chest physiotherapy in cystic fibrosis patients
Time Frame
24 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cystic fibrosis
Exclusion Criteria:
Non-adherence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stian Hammer
Organizational Affiliation
Dept. of Physiotherapy, Haukeland University Hospital, Bergen, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Thoracic Medicine, Haukeland University Hospital
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
High Volumes of Hypertonic Saline and Chest Physiotherapy in CF Patients
We'll reach out to this number within 24 hrs