High Flow Nasal Cannula in Patients Undergoing Gastroscopy

Gastroscopy Clinical Trial

Official title:

High-flow Nasal Cannula Oxygen Therapy for Outpatients Undergoing Gastroscopy: a Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05693298
• Other study ID #: EGDS HFNC
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2023
• Source: University Magna Graecia
• Contact: Federico Longhini
• Phone: +393475395967
• Email: longhini.federico[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroscopy

Intervention

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%
• 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%

Locations

Country	Name	City	State
Italy	AOU Mater Domini	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial blood gases at end of the procedure	Arterial blood will be sample for gas analysis	Through study completion, an average of 15 minutes
Secondary	Respiratory effort at end of the procedure	The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction	Through study completion, an average of 15 minutes
Secondary	Respiratory effort at baseline	The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction	After 1 minute from study beginning
Secondary	Respiratory effort at the beginning of the gastroscopy	The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction	5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment
Secondary	Respiratory effort after the gastroscopy	The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction	After 10 minute from the end of the endoscopy
Secondary	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	5 minutes before the beginning of the endoscopy, while receiving the assigned treatment, compared to baseline
Secondary	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	Through study completion, an average of 15 minutes
Secondary	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	After 10 minute from the end of the endoscopy, compared to baseline
Secondary	Arterial blood gases at baseline	Arterial blood will be sample for gas analysis	After 1 minute from study beginning