Clinical trial NCT05693298: High Flow Nasal Cannula in Patients Undergoing Gastroscopy
Official title: High-flow Nasal Cannula Oxygen Therapy for Outpatients Undergoing Gastroscopy: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroscopy
Keywords: Gastroscopy
High Flow Nasal Cannula
Gas exchange
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Arterial blood gases at end of the procedure
timeFrame: Through study completion, an average of 15 minutes
Secondary outcomes:
measure: Respiratory effort at end of the procedure
timeFrame: Through study completion, an average of 15 minutes
measure: Respiratory effort at baseline
timeFrame: After 1 minute from study beginning
measure: Respiratory effort at the beginning of the gastroscopy
timeFrame: 5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment
measure: Respiratory effort after the gastroscopy
timeFrame: After 10 minute from the end of the endoscopy
measure: Change of end-expiratory lung impedance (dEELI) from baseline at the beginning of the gastroscopy
timeFrame: 5 minutes before the beginning of the endoscopy, while receiving the assigned treatment, compared to baseline
measure: Change of end-expiratory lung impedance (dEELI) from baseline at end of the procedure
timeFrame: Through study completion, an average of 15 minutes
measure: Change of end-expiratory lung impedance (dEELI) from baseline after gastroscopy
timeFrame: After 10 minute from the end of the endoscopy, compared to baseline
measure: Arterial blood gases at baseline
timeFrame: After 1 minute from study beginning
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: AOU Mater Domini
Study officials:
affiliation: Magna Graecia University
name: Federico Longhini, MD
role: PRINCIPAL_INVESTIGATOR
References: