High Volumes of Hypertonic Saline and Chest Physiotherapy in CF Patients

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: Hypertonic saline; Procedure: Physiotherapy

• Registration Number: NCT01943890
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-05-16
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-16
• Last Update Submitted: 2013-09-16
• Study First Posted: 2013-09-17
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Cystic fibrosis

Exclusion Criteria

• Non-adherence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physiotherapy and hypertonic saline	Hypertonic saline	Chest physiotherapy integrated with inhalation of hypertonic saline
Physiotherapy and hypertonic saline	Physiotherapy	Chest physiotherapy integrated with inhalation of hypertonic saline

Primary Outcome Measures

Name	Time	Method
Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second	24 months

Secondary Outcome Measures

Name	Time	Method
Implementation of nebulised high volumes of hypertonic saline in cystic fibrosis patients	24 months	Establishment of a standardized routine of nebulised high volumes of hypertonic saline including chest physiotherapy in cystic fibrosis patients

Trial Locations

Locations (1)

Dept. of Thoracic Medicine, Haukeland University Hospital; 🇳🇴 Bergen, Norway