High Flow Nasal Cannula in Patients Undergoing Gastroscopy
- Conditions
- Gastroscopy
- Interventions
- Device: Conventional Oxygen TherapyDevice: High Flow Nasal Cannula
- Registration Number
- NCT05693298
- Lead Sponsor
- University Magna Graecia
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- outpatients with the indication to diagnostic gastroscopy
- life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Treatment Conventional Oxygen Therapy 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 High Flow Nasal Cannula 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.
- Primary Outcome Measures
Name Time Method Arterial blood gases at end of the procedure Through study completion, an average of 15 minutes Arterial blood will be sample for gas analysis
- Secondary Outcome Measures
Name Time Method Respiratory effort at baseline After 1 minute from study beginning The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Respiratory effort at end of the procedure Through study completion, an average of 15 minutes The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Change of end-expiratory lung impedance (dEELI) from baseline after gastroscopy After 10 minute from the end of the endoscopy, compared to baseline change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Respiratory effort after the gastroscopy After 10 minute from the end of the endoscopy The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Respiratory effort at the beginning of the gastroscopy 5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Change of end-expiratory lung impedance (dEELI) from baseline at the beginning of the gastroscopy 5 minutes before the beginning of the endoscopy, while receiving the assigned treatment, compared to baseline change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Change of end-expiratory lung impedance (dEELI) from baseline at end of the procedure Through study completion, an average of 15 minutes change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Arterial blood gases at baseline After 1 minute from study beginning Arterial blood will be sample for gas analysis
Trial Locations
- Locations (1)
AOU Mater Domini
🇮🇹Catanzaro, Italy