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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
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 will be administered through nasal cannula with a oxygen flow set to achieve a peripheral oxygen saturation equal or greater than 94%
AOU Mater Domini
Catanzaro, Italy
Arterial blood gases at end of the procedure
Arterial blood will be sample for gas analysis
Time frame: Through study completion, an average of 15 minutes
Respiratory effort at end of the procedure
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Time frame: Through study completion, an average of 15 minutes
Respiratory effort at baseline
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Time frame: After 1 minute from study beginning
Respiratory effort at the beginning of the gastroscopy
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Time frame: 5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment
Respiratory effort after the gastroscopy
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Time frame: After 10 minute from the end of the endoscopy
Change of end-expiratory lung impedance (dEELI) from baseline at the beginning of the gastroscopy
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Time frame: 5 minutes before the beginning of the endoscopy, while receiving the assigned treatment, compared to baseline
Change of end-expiratory lung impedance (dEELI) from baseline at end of the procedure
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Time frame: Through study completion, an average of 15 minutes
Change of end-expiratory lung impedance (dEELI) from baseline after gastroscopy
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Time frame: After 10 minute from the end of the endoscopy, compared to baseline
Arterial blood gases at baseline
Arterial blood will be sample for gas analysis
Time frame: After 1 minute from study beginning
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