High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography With Intravenous Sedation.

Study Overview
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Brief Summary
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High flow nasal cannula provides adequate oxygenation in patients with compromised pulmonary function. Very few studies in the literature addressed its use with IV sedation in the OR. Successful application of High Flow nasal cannula in intravenous deep sedation cases in the OR will benefit in the reduction of airway manipulation and side effects from general anesthesia. This study aims to find out the optimal nasal cannula flow rate for maintenance of safe IV deep sedation in endoscopic retrograde cholangiopancreatography (ERCP) patients and to assess gastroenterologist and patient satisfaction.

Official Title
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High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography With Intravenous Sedation.

Conditions
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High-flow Nasal Cannula, Intravenous Sedation

Intervention / Treatment
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* Device: High flow nasal cannula (15 L/m)
* Device: High flow nasal cannula (30 L/m)
* Device: High flow nasal cannula (60 L/m)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient able to give consent. Patient undergoing deep sedation. Patient undergoing ERCP procedure with no restrictions on the duration of the procedure. Age > 18 years Patients with BMI < 40 kg/m2 Exclusion Criteria: Patient unable to give consent Patient refusal to participate Patients undergoing general anesthesia age less than 18 years old Patients with severe heart failure (EF<30%) Morbidly obese Patients with BMI > 40 kg/m2 Patients with sleep apnea Claustrophobia Risk of aspiration due to severe reflux Facial injury, facial malformation Nasal defects/obstruction ASA 4 patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>High flow rate of 5 L/min and FiO2 of 40% | |
| Experimental: Group 1<br>Nasal cannula at flow rate of 15 L/min and FiO2 of 40% | Device: High flow nasal cannula (15 L/m)<br>* nasal cannula at a flow rate of 15 l/min and FiO2 of 40%<br>|
| Experimental: Group 2<br>Nasal cannula at flow rate of 30 L/min and FiO2 of 40% | Device: High flow nasal cannula (30 L/m)<br>* nasal cannula at a flow rate of 30l/min and FiO2 of 40%<br>|
| Experimental: Group 3<br>Nasal cannula at flow rate of 60 L/min and FiO2 of 40% | Device: High flow nasal cannula (60 L/m)<br>* nasal cannula at flow rate of 60L/min. Oxygen supplementation will be at an FiO2 of 40%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal flow rate | The optimal flow rate stabilized for the patient which is determined by the oxygen saturation (%) | During the surgery |