High Flow Nasal Cannula in Patients Undergoing Gastroscopy

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

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 Overview

• Status: Not yet recruiting
• Conditions: Gastroscopy
• Intervention / Treatment: Device: High Flow Nasal Cannula; Device: Conventional Oxygen Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Federico Longhini; Phone Number: +393475395967; Email: longhini.federico@gmail.com

Study Locations

• Italy
  • Catanzaro, Italy
    • AOU Mater Domini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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%
Active Comparator: Standard Treatment; 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	Device: 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Arterial blood gases at baseline	Arterial blood will be sample for gas analysis	After 1 minute from study beginning

Collaborators and Investigators

• Sponsor: University Magna Graecia

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: High Flow Nasal Cannula; Gastroscopy; Gas exchange
• Other Study ID Numbers: EGDS HFNC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The full protocol, datasets used and analysed during the current study will be available on reasonable request e-mailing the corresponding author
• IPD Sharing Time Frame: The data will be shared after results publication of indexed journal in english language
• IPD Sharing Access Criteria: On reasonable request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No