Gastroscopy
Conditions
Keywords
Gastroscopy, High Flow Nasal Cannula, Gas exchange
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).
Interventions
DEVICEHigh 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 will be administered through nasal cannula with a oxygen flow set to achieve a peripheral oxygen saturation equal or greater than 94%
Sponsors
University Magna Graecia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* outpatients with the indication to diagnostic gastroscopy
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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 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 |
| 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 |
| Arterial blood gases at baseline | After 1 minute from study beginning | Arterial blood will be sample for gas analysis |
| 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 |
Countries
Italy
Contacts
Primary ContactFederico Longhini
Outcome results
None listed