Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Use of High Frequency Chest Wall Oscillation During an Acute Infective Pulmonary Exacerbation of Cystic Fibrosis
Brief Summary: High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucus clearance compared with a control group. These observations led to the development of The Vest® which is a non-stretchable jacket connected to an air-pulse generator and worn by the patient over the chest wall. The generator rapidly inflates and deflates The Vest®, which gently compresses and releases the chest wall between 5 and 20 times per second. This generates mini-coughs that are said to dislodge mucus from the bronchial walls and to facilitate its movement up the airways. The Vest® has been shown to reduce the viscosity of mucus and this should further enhance mucus clearance.

People with cystic fibrosis (CF), admitted to hospital with an acute infective pulmonary exacerbation, should increase the frequency and duration of their airway clearance sessions owing to the increase in quantity and viscosity of purulent bronchial secretions.In the United Kingdom, and in many other countries, the availability of physiotherapists to assist with the recommended number of daily treatments is insufficient to meet patient need. If the use of high frequency chest wall oscillation, in addition to 'usual' self airway clearance techniques, in the early morning and evening was to facilitate recovery from an exacerbation, this would indicate an important place for high frequency chest wall oscillation in the management of people with cystic fibrosis.

Hypothesis:

The addition of high frequency chest wall oscillation to twice daily supervised physiotherapy is as effective as the addition of self treatment in facilitating recovery from an acute infective pulmonary exacerbation, as measured by improvement in lung function, specifically forced expiratory volume in one second (FEV1).


Options:
A: Inclusion Criteria:

* Pass the inhalation test
* Chronic sputum production, at least ≥ 10 ml /24h
* Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium\>70 mmol/l or sweat chloride of\>60 mmol/l)
* Clinically stable at the time of recruitment (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 weeks)
* Trained in the use of autogenic drainage technique (at least 6 months)
* Inhaling hypertonic saline since at least 6 months
* To be able to provide written, informed consent and perform the protocol and the evaluations

Exclusion Criteria:

* Active massive hemoptysis during the previous 2 months
* Patient in transplantation or retransplantation list
* Patient already participating in another study at the same time
B: Inclusion Criteria:

* Male or female 6 years of age or older at enrollment and be competent in performing spirometry.
* Confirmed diagnosis of CF.
* FEV1\> 45% predicted as calculated by Wang reference equations
* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
* Clinically stable at enrollment with no evidence of respiratory exacerbation within a month of enrollment as assessed by the site CF Physician.
* Willingness to adhere to prescribed treatment regimen.

Exclusion Criteria:

* Diagnosis of Allergic Broncho-Pulmonary Aspergillosis, or a persistent culture for B.cepacia complex within the previous 1 year period
* .On active treatment for non Tuberculous Mycobacterium.
* Use of intravenous antibiotics within the previous 14 days of enrollment.
* Initiation and or change in maintenance therapy within 14 days of enrollment.
* Use of systemic corticosteriods (1mg/kg if \< 20 kg or 20 mg of prednisone per day) within 14 days of enrollment.
* Concurrent participation in another study that could potentially affect the present study.
* Haemoptysis of over 20 mls on more than 2 occasions within the previous 30 days from enrollment.
* A pneumothorax in the six months preceding the study.
* Presence of a condition or abnormality that in the opinion of the site CF Physician would compromise the safety of the patient or the quality of the data.
C: Inclusion Criteria:

* Diagnosis of cystic fibrosis
* Hospitalised patients admitted with a pulmonary infection
* Forced expiratory volume in one second (FEV1)of 15% predicted or over
* 16 years of age or over

Exclusion Criteria:

* Current severe haemoptysis
* Rib fractures or history of spontaneous rib fractures
* pregnancy
* Lung abscess
* End stage disease
* Requiring more than two assisted treatment sessions per day
* Requiring treatment with positive pressure
* Inability to give consent
D: Inclusion Criteria:

* Diagnosis of cystic fibrosis (confirmed by genotype or a sweat sodium concentration of \>70mmol/l or sweat chloride of \>60mmol/l)
* Sixteen years of age or over
* Patients admitted to the Royal Brompton Hospital with a pulmonary exacerbation of which is resolving. Patients will be considered for inclusion from day 7 of treatment to 3 days prior to discharge (as determined by a member of the cystic fibrosis medical team and have spirometric values within 20% of the mean of the last two stable recordings (at least 1 month apart)
* Patients with an established airway clearance regime that they have used for 3 months or more

Exclusion Criteria:

* Current moderate haemoptysis (greater than streaking in the sputum)
* Current pneumothorax or history of pneumothorax in the 3 months prior to consideration for the study
* Current dependency on positive pressure support with airway clearance via the IPPB (Intermittent Positive Pressure Breathing) machine or NIV
* Previous history of spontaneous rib fractures
* Pregnancy
* Inability to give consent for treatment or measurement
* Current participation in another study
* If the patient requires more than 2 airway clearance sessions a day

Answer: C