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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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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20180130001 |
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Date of registration:
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30/01/2018 |
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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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Benefits and safety of high flow nasal oxygen in mild to moderate acute hypoxemic respiratory failure at medical ward, a randomized trial
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Scientific title:
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Benefits and safety of high flow nasal oxygen in mild to moderate acute hypoxemic respiratory failure at medical ward, a randomized trial |
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Date of first enrolment:
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30/01/2018 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20180130001 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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Phase 4
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Contacts
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Name:
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Chalerm
Liwsrisakun |
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Address:
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Department of Internal Medicine, Faculty of medicine, Chiang mai University
50200
Chiang Mai
Thailand |
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Telephone:
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0818813880 |
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Email:
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chalermliw@hotmail.com |
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Affiliation:
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Chiang Mai University |
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Name:
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Chalerm
Liwsrisakun |
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Address:
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Department of Internal Medicine, Faculty of medicine, Chiang mai University
50200
Chiang mai
Thailand |
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Telephone:
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0818813880 |
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Email:
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chalermliw@hotmail.com |
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Affiliation:
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Chiang Mai University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: all the following
1. Mild to moderate acute hypoxemic respiratory failure(table)
2. Admitted at general medical wards
3. Age >18 years old
Definition of mild to moderate hypoxemic respiratory failure
• Respiratory rate >25 breaths/min and/or increased work of breathing, evidenced by clinical signs (dyspnea, use of accessory muscles of respiration, diaphoresis) AND
• Requiring >4 L/min O2 via nasal cannula or requiring O2 therapy equivalent to
FiO2 >0.4 to keep PaO2 >60 mmHg or SpO2 >90% for >1 hour
Exclusion criteria: 1. PaCO2 >45 mmHg
2. Post-extubation respiratory failure (respiratory failure within 48 hr after extubation)
3. Life-threatening ARF requiring immediate IMV
4. Shock
5. Contraindications to NIV
6. A do-not-intubate order
7. Patients refused to participate the study
8. Intra-abdominal hypertension
9. Pulmonary tuberculosis
Age minimum:
18 Years
Age maximum:
0 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adult inpatients who were admitted in medical general wards with the diagnosis mild to moderate acute hypoxia.
high flow nasal oxygen, moderate acute hypoxia,
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high flow nasal oxygen, moderate acute hypoxia,
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Intervention(s)
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standard oxygen therapy ,High-flow nasal oxygen (HFNO)
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Standard Oxygen supplementation via nasal cannula.,HFNO system consists of nasal cannula, heated inspiratory circuit, humidifier, air-oxygen blender and flow meter. Gas from air-oxygen blender is humidified and heated before given to patient.
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Active Comparator Device,Active Comparator Device
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Primary Outcome(s)
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Rate of required NIV or IMV within 48 hours after randomization within 48 hours after randomization Number of subject who need NIV or IMV initiation within 48 hours after randomization
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Secondary Outcome(s)
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30-day mortality 30 day Number of subject died at 30 day after randomization
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Source(s) of Monetary Support
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no
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
researchmed@cmu.ac.th
Research Ethics Committee
053936643 Ext.
researchmed@cmu.ac.th
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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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01/12/2018 |
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URL:
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