Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482879
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-06-26
Brief Title:
Comparison of Hypoxia Between HFNC and SNC in Patient Undergoing UGI Endoscopic Procedures in Deep Sedation
Sponsor:
National Academy of Medical Sciences Nepal
Organization:
National Academy of Medical Sciences Nepal
Study Overview
Official Title:
Comparison of Hypoxia Between High Flow Nasal Canula and Simple Nasal Canula in Patient Undergoing Upper Gastrointestinal Endoscopic Procedures in Deep Sedation
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypoxia frequently occurs as a complication during upper gastrointestinal endoscopic procedures performed under deep sedation Traditional oxygen delivery methods such as the simple nasal cannula are commonly used to prevent hypoxia in these cases The high-flow nasal cannula capable of delivering FiO2 levels of up to 1 and flow rates of up to 70 lmin offers additional benefits including positive end-expiratory pressure and reduced dead space We hypothesized is that the use of high-flow nasal cannula can decrease the incidence of hypoxia in comparison to simple nasal cannula in patients undergoing upper gastrointestinal endoscopic procedures under deep sedation
This was prospective comparative observational study conducted in a tertiary care center of Nepal with the primary objective to compare the rates of hypoxia SpO2 92 and secondary objectives were to compare interruption of procedure due to hypoxia minimum hypoxia level and episodes of hypoxia between high flow nasal canula flow rate of 30lmin with FiO2 of 05 and simple nasal canula flow rate of 6lmin in patients undergoing upper gastrointestinal endoscopic procedures in semi-prone position in deep sedation using propofol infusion
The study comprised 125 participants 58 in simple nasal canula and 67 in high flow nasal cannula group The incidence of hypoxia in simple nasal cannula and high flow nasal cannula groups with rates of 373 2258 and 164 1167 respectively The relative risk RR of hypoxia was 043 95 CI 023-081 with a p-value of 0009 Procedural interruptions due to hypoxia occurred in 86 558 of participants in the simple nasal cannula group and 447 367 in the high flow nasal cannula group with RR of 017 95 CI 002-141 and a p-value 01 Furthermore the occurrence of multiple episodes of hypoxia was higher in the simple nasal cannula group compared to the high flow nasal cannula group 5 vs 0 with a p-value 0001The use of high flow nasal cannula reduces the occurrence of hypoxia in patients undergoing upper gastrointestinal endoscopic procedures with deep sedation compared to simple nasal cannula
This was prospective comparative observational study conducted in a tertiary care center of Nepal with the primary objective to compare the rates of hypoxia SpO2 92 and secondary objectives were to compare interruption of procedure due to hypoxia minimum hypoxia level and episodes of hypoxia between high flow nasal canula flow rate of 30lmin with FiO2 of 05 and simple nasal canula flow rate of 6lmin in patients undergoing upper gastrointestinal endoscopic procedures in semi-prone position in deep sedation using propofol infusion
The study comprised 125 participants 58 in simple nasal canula and 67 in high flow nasal cannula group The incidence of hypoxia in simple nasal cannula and high flow nasal cannula groups with rates of 373 2258 and 164 1167 respectively The relative risk RR of hypoxia was 043 95 CI 023-081 with a p-value of 0009 Procedural interruptions due to hypoxia occurred in 86 558 of participants in the simple nasal cannula group and 447 367 in the high flow nasal cannula group with RR of 017 95 CI 002-141 and a p-value 01 Furthermore the occurrence of multiple episodes of hypoxia was higher in the simple nasal cannula group compared to the high flow nasal cannula group 5 vs 0 with a p-value 0001The use of high flow nasal cannula reduces the occurrence of hypoxia in patients undergoing upper gastrointestinal endoscopic procedures with deep sedation compared to simple nasal cannula
Detailed Description:
This study was prospective comparative open-label and observational study conducted on tertiary hospital of Nepal between July 2023-April 2024A written informed consent was taken from all the patients before enrolling to study Patient aged more than 16 years ASA-PS grading I-IV both the gender both elective procedures undergoing complex UGI endoscopic procedure in deep sedation under propofol infusion were included Patient not willing to enrolled pre-operative SPO2 92 and pre-operative MAP 60 mm Hg were excluded from study Sixty-two patients were enrolled in each group so total sample size was 124 using following sample size formula
After arriving in the procedure room standard monitoring including pulse oximetry non-invasive blood pressure monitoring and electrocardiography were attached An anesthesiologist assigned made the decision on which oxygenation device to use for the patient In SNC group an oxygen flow rate of 6 lmin where in HFNC group at the beginning of procedure flow was set 10 lmin once patient was induced flow rate increased to 30 lmin with FiO2 of 05 The patients were positioned either laterally or semiprone Prior to the start of the procedure the patient was given an injection of fentanyl 1mcgkg An initial dose of propofol was administered at a rate of 1-15 mgkg by slow titrating manner The sedation level ventilatory patternrate and depth were clinically monitored throughout the procedureThe propofol infusion was kept between 25-150 mcgkgmin aiming for preventing facial grimace agitation or gag reflex while still allowing the patient to respond to painful stimuli In case of any sings of agitation noticed the anaesthesiologist added the additional dose of propofol or increase the propofol infusion rate or both as in our usual practice
In SNC group if SpO2 decreased below 92 flow rate increased to 8 lmin whereas in HFNC group FiO2 increased to 1 and flow rate increased to 50 lmin If desaturation continued despite of above mentioned measure in both groups anesthesiologist increased the FiO2 flow or both Bag mask ventilation and tracheal intubation was done if needed Other events bradycardia needing atropine hypotension needing vasopressor persistent hypoxia needing bag and mask endotracheal intubation was recorded
Hypoxia is defined as a decrease in oxygen saturation 92 Severe hypoxia is defined as a decrease in oxygen saturation 80 Primary outcome was the compare the rate of hypoxia and secondary outcome was to compare the rate of interruption of procedure due to hypoxia and episodes of hypoxia during the procedure between the two groups
After arriving in the procedure room standard monitoring including pulse oximetry non-invasive blood pressure monitoring and electrocardiography were attached An anesthesiologist assigned made the decision on which oxygenation device to use for the patient In SNC group an oxygen flow rate of 6 lmin where in HFNC group at the beginning of procedure flow was set 10 lmin once patient was induced flow rate increased to 30 lmin with FiO2 of 05 The patients were positioned either laterally or semiprone Prior to the start of the procedure the patient was given an injection of fentanyl 1mcgkg An initial dose of propofol was administered at a rate of 1-15 mgkg by slow titrating manner The sedation level ventilatory patternrate and depth were clinically monitored throughout the procedureThe propofol infusion was kept between 25-150 mcgkgmin aiming for preventing facial grimace agitation or gag reflex while still allowing the patient to respond to painful stimuli In case of any sings of agitation noticed the anaesthesiologist added the additional dose of propofol or increase the propofol infusion rate or both as in our usual practice
In SNC group if SpO2 decreased below 92 flow rate increased to 8 lmin whereas in HFNC group FiO2 increased to 1 and flow rate increased to 50 lmin If desaturation continued despite of above mentioned measure in both groups anesthesiologist increased the FiO2 flow or both Bag mask ventilation and tracheal intubation was done if needed Other events bradycardia needing atropine hypotension needing vasopressor persistent hypoxia needing bag and mask endotracheal intubation was recorded
Hypoxia is defined as a decrease in oxygen saturation 92 Severe hypoxia is defined as a decrease in oxygen saturation 80 Primary outcome was the compare the rate of hypoxia and secondary outcome was to compare the rate of interruption of procedure due to hypoxia and episodes of hypoxia during the procedure between the two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None