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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: |
NCT02253667 |
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Date of registration:
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28/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients
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Scientific title:
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Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Patients: a Randomized Controlled Trial |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02253667 |
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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: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Miguel R Gonçalves, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pulmonology Department, University Hospital São João |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Consecutive patients who had end-stage lung disease (lung cancer, pulmonary fibrosis,
COPD, …) - (McCabe score > 3 [<6 months life expectancy] and a Palliative Prognostic
Index score = 4) admitted to hospital because of acute respiratory failure and
distress
- Had chosen to forego all life support and receiving only palliative care
- Severe hypoxemia (PaO2/FiO2< 250)
- At least one of the following: dyspnoea (Borg scale =4), signs of respiratory
distress, and respiratory rate greater than 30 beats per min
Exclusion Criteria:
- Patients had to be competent (Kelly score <4)
- Refusal of treatment
- Weak cough reflex
- Agitation or non-cooperation
- Uncontrolled cardiac ischemia or arrhythmias
- Failure of more than two organs
- Use of opioids within the past 2 weeks
- Adverse reactions to opioids
- History of substance misuse
- Known contraindication for morphine (acute renal failure and recent head injury)
Age minimum:
21 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Respiratory Distress Syndrome
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Lung Disease
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Intervention(s)
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Device: HFONC
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Device: Conventional oxygen therapy
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Primary Outcome(s)
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Opioids
[Time Frame: 2 days]
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Dyspnoea
[Time Frame: 2 days]
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Secondary Outcome(s)
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Patient comfort
[Time Frame: 2 days]
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Mortality
[Time Frame: 6 months]
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Physiologic variables
[Time Frame: 2 days]
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Secondary ID(s)
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PalliativeHFONC
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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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