Clinical trial NCT05687045: High Flow Nasal Cannula in Patients Undergoing Colonoscopy
Official title: High-flow Nasal Cannula Oxygen Therapy for Outpatients Undergoing Colonoscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonoscopy
Keywords: colonoscopy
High Flow Nasal Cannula
Gas exchange
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During colonoscopy, the insertion of the fiberscope and colon 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 colonoscopy. The investigators 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 colonoscopy

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: At the end of the endoscopy
Secondary outcomes:
measure: Respiratory effort at end of the procedure
timeFrame: At the end of the endoscopy
measure: Respiratory effort at baseline
timeFrame: At enrollment
measure: Respiratory effort at the beginning of the colonoscopy
timeFrame: At 5 minutes after the beginning of the procedure
measure: Respiratory effort after the colonoscopy
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 colonoscopy
timeFrame: At 5 minutes after the beginning of the procedure
measure: Change of end-expiratory lung impedance (dEELI) from baseline at end of the procedure
timeFrame: At the end of the endoscopy, compared to baseline
measure: Change of end-expiratory lung impedance (dEELI) from baseline after colonoscopy
timeFrame: After 10 minute from the end of the endoscopy, compared to baseline
measure: Arterial blood gases at baseline
timeFrame: At enrollment
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: AOU Mater Domini
Study officials:
affiliation: Magna Graecia University
name: Federico Longhini
role: PRINCIPAL_INVESTIGATOR
References: