Clinical Trials Directory

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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

TypeNameDescription
DEVICEHigh Flow Nasal CannulaHigh 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%
DEVICEConventional Oxygen TherapyConventional 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.