High-flow Nasal Cannula, Intravenous Sedation
Conditions
Brief summary
The aim of the current study is to compare the incidence of oxygen desaturation in patients receiving HFNC at different flow rates compared to conventional oxygen therapy via a simple cannula during ERCP. Secondary outcomes include lowest average observed oxygen saturation (SpO2), snoring classification scores and satisfaction levels of both patients and gastroenterologists. Participants will be randomized to 3 groups: G0 will receive a 5 l/ min flow rate through a nasal cannula at and FiO2 of 40 %, G1 will receive a 15 l/ min flow rate and FiO2 of 40% and G2: will receive a 60L/min flow rate and FiO2 of 40%.
Detailed description
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. The aim of the current study is to compare the incidence of oxygen desaturation in patients receiving HFNC at different flow rates compared to conventional oxygen therapy via a simple cannula during ERCP. Secondary outcomes include lowest average observed oxygen saturation (SpO2), snoring classification scores and satisfaction levels of both patients and gastroenterologists. A total of 60 patients undergoing ERCP will be equally randomized to 3 groups: G0: will receive a 5 l/ min flow rate through a nasal cannula at and FiO2 of 40 %, G1: will receive a 15 l/ min flow rate and FiO2 of 40% and G2: will receive a 60L/min flow rate and FiO2 of 40%. The three groups' intra-procedure and outcome parameters and variables will be compared. Statistical comparison will be made using the ANOVA, Student's t-test, and Chi-squared test. Level of statistical significance will be considered at p\<0.05. ANOVA test will be performed to compare the different means between the four groups. Minimum and maximum 3 of 17 values will be recorded for each value in all 3 groups. A two sided P value of less than 0.05 will be considered statistically significant.
Interventions
DEVICEHigh flow nasal cannula (15 L/m)
nasal cannula at a flow rate of 15 l/min and FiO2 of 40%
DEVICEHigh flow nasal cannula (30 L/m)
nasal cannula at a flow rate of 30l/min and FiO2 of 40%
DEVICEHigh flow nasal cannula (60 L/m)
nasal cannula at flow rate of 60L/min. Oxygen supplementation will be at an FiO2 of 40%.
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patient able to give consent. 2. Patient undergoing deep sedation. 3. Patient undergoing ERCP procedure with no restrictions on the duration of the procedure. 4. Age \> 18 years 5. Patients with BMI \< 40 kg/m2
Exclusion criteria
1. Patient unable to give consent 2. Patient refusal to participate 3. Patients undergoing general anesthesia 4. age less than 18 years old 5. Patients with severe heart failure (EF\<30%) 6. Morbidly obese Patients with BMI \> 40 kg/m2 7. Patients with sleep apnea 8. Claustrophobia 9. Risk of aspiration due to severe reflux 10. Facial injury, facial malformation 11. Nasal defects/obstruction 12. ASA 4 patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Desaturation | During the surgery | Desaturation (SpO2≤95%) or a drop of more than 5% from baseline SpO2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean SpO2 | During procedure | Mean SpO2 (%) |
| Duration of the procedure | During procedure | Duration of the procedure measured in minutes |
| Snoring status | During procedure | Snoring status measured as Yes/No |
| Lowest SpO2 | During procedure | Lowest SpO2 (%) |
| Gastroenterologists' satisfaction | During procedure | Gastroenterologists' satisfaction measured using a 5-point Likert scale |
| Patients' satisfaction | During procedure | Patients' satisfaction measured using a 5-point Likert scale |
| Snoring snore | During procedure | snoring score assessed using a subjective snoring classification developed at Stanford on a scale from 0 to 10 |
Countries
Lebanon
Outcome results
None listed