High Flow Nasal Cannula in Patients Undergoing Gastroscopy
NCT ID: NCT05693298
Last Updated: 2023-01-20
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
36 participants
INTERVENTIONAL
2023-02-01
2023-06-30
Brief Summary
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High-flow nasal cannula (HFNC) therapy is a mixed air-oxygen supply system able to deliver heated humidified gas up to 60 L/min of flow rate, with an inspiratory oxygen fraction (FiO2) ranging from 21% to 100%. Increasing evidence supports the use of HFNC in several clinical conditions and settings. When compared to standard therapy (ST), HFNC results in enhanced gas exchange and improved comfort.
No studies have yet assessed the benefits of HFNC versus ST during and after gastroscopy. We designed this unblinded randomized controlled trial to assess whether HFNC, compared to ST, improves oxygenation at the end of the procedure (primary endpoint). Additional endpoints were: 1) the lowest peripheral saturation of oxygen (SpO2) and the number of oxygen desaturations; 2) the changes of end-expiratory lung impedance and tidal impedance assessed by Electrical Impedance Tomography (EIT); 3) the effects on diaphragm function assessed by ultrasound (DUS).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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High Flow Nasal Cannula
High Flow Nasal cannula is a system to deliver heated and humidified oxygen with an inspired oxygen fraction between 21 and 100% through large bore nasal cannula. The system delivers a flow up to 60 liters/min.
High Flow Nasal Cannula
High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%
Standard Treatment
If peripheral oxygen saturation will be \< 95%, conventional oxygen therapy will be administered through common nasal cannula with a flow up to 6 Liters per minute
Conventional Oxygen Therapy
Conventional Oxygen Therapy will be administered through nasal cannula with a oxygen flow set to achieve a peripheral oxygen saturation equal or greater than 94%
Interventions
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High Flow Nasal Cannula
High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%
Conventional Oxygen Therapy
Conventional Oxygen Therapy will be administered through nasal cannula with a oxygen flow set to achieve a peripheral oxygen saturation equal or greater than 94%
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* need for invasive or non invasive ventilation
* presence of pneumothorax or pulmonary enphisema or bullae
* recent (within 1 week) thoracic surgery
* presence of chest burns
* presence of tracheostomy
* pregnancy
* nasal or nasopharyngeal diseases
* dementia
* lack of consent or its withdrawal
18 Months
ALL
No
Sponsors
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University Magna Graecia
OTHER
Responsible Party
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Federico Longhini
Director of the Intensive Care and Anesthesia Department
Principal Investigators
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Federico Longhini, MD
Role: PRINCIPAL_INVESTIGATOR
Magna Graecia University
Locations
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AOU Mater Domini
Catanzaro, , Italy
Countries
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Central Contacts
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Other Identifiers
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EGDS HFNC
Identifier Type: -
Identifier Source: org_study_id
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