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High Volumes of Hypertonic Saline and Chest Physiotherapy in CF Patients

NCT ID: NCT01943890

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis

Keywords

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Hypertonic saline Lung physiotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Physiotherapy and hypertonic saline

Chest physiotherapy integrated with inhalation of hypertonic saline

Group Type EXPERIMENTAL

Hypertonic saline

Intervention Type DEVICE

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

Physiotherapy

Intervention Type PROCEDURE

Interventions

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Hypertonic saline

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 DEVICE

Physiotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Cystic fibrosis

Exclusion Criteria

* Non-adherence
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stian Hammer

Role: PRINCIPAL_INVESTIGATOR

Dept. of Physiotherapy, Haukeland University Hospital, Bergen, Norway

Locations

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Dept. of Thoracic Medicine, Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2009/2125

Identifier Type: -

Identifier Source: org_study_id