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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01885650 |
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Date of registration:
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17/06/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Addition of Non-Invasive Ventilation To Airway Clearance Techniques In Adults With Cystic Fibrosis
NIV |
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Scientific title:
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Non-Invasive Ventilation (NIV) For Positive Pressure Support. A Randomised Cross-Over Trial To Evaluate The Short-Term Effects of NIV As An Adjunct To Airway Clearance Techniques in Adults With Cystic Fibrosis. |
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Date of first enrolment:
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July 2013 |
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Target sample size:
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14 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01885650 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
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Phase:
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N/A
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Gemma Stanford, BSc (Hons) Physiotherapy |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Royal Brompton & Harefield NHS Foundation Trust |
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Key inclusion & exclusion criteria
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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
Age minimum:
16 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Other: Airway Clearance Techniques
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Primary Outcome(s)
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Sputum weight (wet) expectorated during, up to 30 minutes after treatment and the 24 hour total weight
[Time Frame: 24 hours]
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Secondary Outcome(s)
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Oxygen saturations during the treatment session
[Time Frame: During the treatment]
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Lung function tests
[Time Frame: 5 minutes before treatment, within 5 minutes immediately after treatment and 30 minutes after treatment]
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Qualitative assessment using 10 centimetre Visual Analogue Scale (VAS) of ease of clearance, work of breathing during clearance and satisfaction of each treatment approach (A or B).
[Time Frame: Within 5 minutes immediately after each treatment]
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Secondary ID(s)
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13/LO/0565
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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