Trials / Unknown
UnknownNCT05693298
High Flow Nasal Cannula in Patients Undergoing Gastroscopy
High-flow Nasal Cannula Oxygen Therapy for Outpatients Undergoing Gastroscopy: a Randomized Controlled Trial.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- University Magna Graecia · Academic / Other
- Sex
- All
- Age
- 18 Months
- Healthy volunteers
- Not accepted
Summary
During gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce modifications to respiratory mechanics, respiratory effort and breathing pattern. 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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% |
| DEVICE | 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% |
Timeline
- Start date
- 2023-02-01
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
- First posted
- 2023-01-20
- Last updated
- 2023-01-20
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05693298. Inclusion in this directory is not an endorsement.