High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage
NCT ID: NCT03534960
Last Updated: 2018-05-29
Study Results
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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UNKNOWN
NA
150 participants
INTERVENTIONAL
2018-01-13
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High Flow Nasal Oxygen Therapy
Patients are randomized to the high flow nasal oxygen therapy group
High Flow Nasal Oxygen Therapy
Nasal cannula flows of 3 to 8 lpm via systems approved to provide increased humidification and warmth to inspired gas
Nasal CPAP
Patients are randomized to the nasal continuous positive airway pressure treatment group
Nasal CPAP
Standard nasal CPAP via "bubble" or ventilator support at levels of 4-8 cm H2O
Interventions
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High Flow Nasal Oxygen Therapy
Nasal cannula flows of 3 to 8 lpm via systems approved to provide increased humidification and warmth to inspired gas
Nasal CPAP
Standard nasal CPAP via "bubble" or ventilator support at levels of 4-8 cm H2O
Eligibility Criteria
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Inclusion Criteria
2. Hypercapnic respiratory failure:
PaO2\<60mmHg and PaCO2 \>50 mmHg
3. Candidate for non-invasive respiratory support as a result of:
1. an intention to manage the patient with non-invasive (no endotracheal tube) respiratory support
2. an intention to extubate the patient being managed with intubated respiratory support to non-invasive support
Exclusion Criteria
2. Active air leak syndrome
3. Patients with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis,
4. Patients with significant abdominal or respiratory malformations including tracheo-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia
5. PaCO2\<50mmHg
1 Year
18 Years
ALL
No
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Bin He
Associate Professor
Locations
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Ethics Committee of Xinhua Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XH-17-007
Identifier Type: -
Identifier Source: org_study_id
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