High Flow Nasal Cannula in Patients Undergoing Colonoscopy

Not Applicable

Not yet recruiting

• Conditions: Colonoscopy
• Interventions: Device: Conventional Oxygen Therapy; Device: High Flow Nasal Cannula

• Registration Number: NCT05687045
• Lead Sponsor: University Magna Graecia

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-14
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-12
• Last Update Submitted: 2023-01-12
• Study First Posted: 2023-01-17
• Last Update Posted: 2023-01-17
• Study Start: 2023-02-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment	Conventional Oxygen Therapy	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
High Flow Nasal Cannula	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.

Primary Outcome Measures

Name	Time	Method
Arterial blood gases at end of the procedure	At the end of the endoscopy	Arterial blood will be sample for gas analysis

Secondary Outcome Measures

Name	Time	Method
Respiratory effort at end of the procedure	At the end of the endoscopy	The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Respiratory effort at the beginning of the colonoscopy	At 5 minutes after the beginning of the procedure	The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Respiratory effort after the colonoscopy	After 10 minute from the end of the endoscopy	The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Arterial blood gases at baseline	At enrollment	Arterial blood will be sample for gas analysis
Change of end-expiratory lung impedance (dEELI) from baseline at end of the procedure	At 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
Change of end-expiratory lung impedance (dEELI) from baseline after colonoscopy	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
Change of end-expiratory lung impedance (dEELI) from baseline at the beginning of the colonoscopy	At 5 minutes after the beginning of the procedure	change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Respiratory effort at baseline	At enrollment	The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction

Trial Locations

Locations (1)

AOU Mater Domini; 🇮🇹 Catanzaro, Italy