High Flow Nasal Cannula in Patients Undergoing Colonoscopy

University Magna Graecia

Status: Not yet enrolling

Conditions: Colonoscopy

Treatments: Device: High Flow Nasal Cannula; Device: Conventional Oxygen Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05687045

Colon-HFNC

Details and patient eligibility

About

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).

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

High Flow Nasal Cannula

Experimental group

Description:

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.

Treatment:

Device: High Flow Nasal Cannula

Standard Treatment

Active Comparator group

Description:

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

Treatment:

Device: Conventional Oxygen Therapy