Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593509
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
The Effectiveness of High Flow Nasal Cannula Versus Noninvasive Ventilation and Conventional Oxygen Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of High Flow Nasal Cannula Versus Noninvasive Ventilation and Conventional Oxygen Therapy in Patients Weaned from Invasive Mechanical Ventilation
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective randomized controlled study enrolling sixty patients who fulfilled weaning criteria after requiring invasive MV After extubation patients were randomized into three groups 20 patients per group NIV group HFNC group and COT group Primary outcomes included reintubation rates at certain time points and after 48 hours post-extubation while secondary outcomes included time to reintubation ICU length of stay ICU mortality Objective To compare the rate of reintubation within 48 hours after extubation among patients receiving NIV HFNC and COT as post-extubation respiratory support
Detailed Description:
Reintubation after liberation from mechanical ventilation MV is a wellknown adverse event seen in different patients subtypespost surgical traumamedical as well as in surgical and medical intensive care units ICUs The cumulative probability of reintubation following planned and unplanned extubation in 185 ICUs in the United States reached up to 10 and 90 occurred within the first 96 hours 4 days after first extubation the median time to reintubation was 15 hours
Proper timing for extubation is crucial to minimize extubation failure and about 12 to 14 of patients planned for extubation would require reintubation within 48 to 72 hours mostly within the first 24 hours in a multivariate analysis duration of MV more than 7 days prior to extubation ineffective cough and severe systolic left ventricular dysfunction were independent factors associated with extubation failure whereas in another studyage and underlying diseases were other factors associated with higher extubation failure with rates reaching up to 34 in patients 65 yrs or older those with chronic respiratory or cardiac disorders and the condition was specifically associated with significant rapid clinical deterioration and worsening of daily organ dysfunction scores reflecting a direct effect of reintubation on patient outcomes Mortality risk is reported to be five times higher in patients who require reintubation after extubation from MV
Postextubation sequential oxygen devices applied as first-line therapy after extubation include noninvasive ventilation NIV high-flow nasal cannula HFNC and conventional oxygen therapy COT
COT delivered via masks and nasal prongs has been widely used as the main sequential supportive oxygen therapy administered to patients after extubation However the maximal oxygen flow rates that these devices can deliver are limited with maximum flow rate up to 15 Lmin only which is usually far lower than the demands that postextubation patients would require The fraction of inspired oxygen FiO2 delivered by COT is unstable because of the entertainment of room air and dilution of the inspired oxygen
Potential benefits of NIV include the ability to provide a relatively consistent and wider range of FiO2 compared with COT Moreover NIV creates an extrinsic positive end expiratory pressure which aids in recruitment of collapsed alveoli
The American College of Chest PhysiciansAmerican Thoracic Society ACCPATS clinical practice guidelines for liberation from MV in the critically ill highlight the importance of usage of preventive NIV in patients at high risk of reintubation and emphasizing its impact on improving oxygenation ventilation decreasing hospital mortality length of hospital stay and incidence of ventilator associated pneumonia VAP Evidence suggest that NIV may prevent postextubation respiratory failure and avoid reintubation if it is applied soon after extubation On the other hand this strategy is associated with worse outcomes if applied after development of postextubation acute respiratory failure ARF In addition intolerance to NIV is quite common in clinical practice eye irritation skin damage interruption in diet and clearance of airways secretion are common adverse events and can worsen the patients outcome These limitations urge investigators to explore other alternative oxygen delivery devices and search for potential roles in improving clinical outcomes in the post extubation setting
High flow nasal cannula HFNC is a novel high flow oxygen device with established efficiency it is well tolerated by patients easily applied and can provide fully humidified heated high-flow rates up to 60 Lmin a constant high fraction of inspired oxygen FiO2 021 - 10 and flow-dependent continuous positive airway pressure 2-5 cm H2O which in turn increases end-expiratory lung volume and aids in alveolar recruitment and reduces atelectasis subsequently improving ventilation-perfusion mismatch The continuous high flow of oxygen guarantees both higher tidal volume with adequate minute ventilation and sufficient oxygenation improves inspiratory flow dynamics and decrease work of breathing by improving thoracoabdominal synchrony In addition pharyngeal dead space washout effect decreases carbon dioxide in a faster manner Finally the heated humidification flow creates physiological conditions preserving mucosal integrity reducing mucosal inflammation and facilitating clearance of secretions thereby improving the oxygenation and further decreasing the risk of atelectasis
Several studies have investigated these available devices and compared their efficacy in lowering reintubation rates after extubation but results are conflicting and inconsistent and no study could conclude that either HFNC NIV or COT is superior to prevent reintubation One randomized controlled trial RCT reported that HFNC was associated with a lower rate of reintubation in low-risk patients compared to COT Another RCT in high-risk non-hypercapnic patients and concluded that HFNC could not decrease rate of reintubation compared with COT A third study showed that HFNC and NIV are equally effective in lowering reintubation rate
In Egypt researchers have also studied and compared the effectiveness of these modalities in different clinical ICU settings with comparable efficacies between three devices The objective of the current work is to compare the rate of reintubation after extubation using HFNC versus NIV and COT as sequential respiratory support
Proper timing for extubation is crucial to minimize extubation failure and about 12 to 14 of patients planned for extubation would require reintubation within 48 to 72 hours mostly within the first 24 hours in a multivariate analysis duration of MV more than 7 days prior to extubation ineffective cough and severe systolic left ventricular dysfunction were independent factors associated with extubation failure whereas in another studyage and underlying diseases were other factors associated with higher extubation failure with rates reaching up to 34 in patients 65 yrs or older those with chronic respiratory or cardiac disorders and the condition was specifically associated with significant rapid clinical deterioration and worsening of daily organ dysfunction scores reflecting a direct effect of reintubation on patient outcomes Mortality risk is reported to be five times higher in patients who require reintubation after extubation from MV
Postextubation sequential oxygen devices applied as first-line therapy after extubation include noninvasive ventilation NIV high-flow nasal cannula HFNC and conventional oxygen therapy COT
COT delivered via masks and nasal prongs has been widely used as the main sequential supportive oxygen therapy administered to patients after extubation However the maximal oxygen flow rates that these devices can deliver are limited with maximum flow rate up to 15 Lmin only which is usually far lower than the demands that postextubation patients would require The fraction of inspired oxygen FiO2 delivered by COT is unstable because of the entertainment of room air and dilution of the inspired oxygen
Potential benefits of NIV include the ability to provide a relatively consistent and wider range of FiO2 compared with COT Moreover NIV creates an extrinsic positive end expiratory pressure which aids in recruitment of collapsed alveoli
The American College of Chest PhysiciansAmerican Thoracic Society ACCPATS clinical practice guidelines for liberation from MV in the critically ill highlight the importance of usage of preventive NIV in patients at high risk of reintubation and emphasizing its impact on improving oxygenation ventilation decreasing hospital mortality length of hospital stay and incidence of ventilator associated pneumonia VAP Evidence suggest that NIV may prevent postextubation respiratory failure and avoid reintubation if it is applied soon after extubation On the other hand this strategy is associated with worse outcomes if applied after development of postextubation acute respiratory failure ARF In addition intolerance to NIV is quite common in clinical practice eye irritation skin damage interruption in diet and clearance of airways secretion are common adverse events and can worsen the patients outcome These limitations urge investigators to explore other alternative oxygen delivery devices and search for potential roles in improving clinical outcomes in the post extubation setting
High flow nasal cannula HFNC is a novel high flow oxygen device with established efficiency it is well tolerated by patients easily applied and can provide fully humidified heated high-flow rates up to 60 Lmin a constant high fraction of inspired oxygen FiO2 021 - 10 and flow-dependent continuous positive airway pressure 2-5 cm H2O which in turn increases end-expiratory lung volume and aids in alveolar recruitment and reduces atelectasis subsequently improving ventilation-perfusion mismatch The continuous high flow of oxygen guarantees both higher tidal volume with adequate minute ventilation and sufficient oxygenation improves inspiratory flow dynamics and decrease work of breathing by improving thoracoabdominal synchrony In addition pharyngeal dead space washout effect decreases carbon dioxide in a faster manner Finally the heated humidification flow creates physiological conditions preserving mucosal integrity reducing mucosal inflammation and facilitating clearance of secretions thereby improving the oxygenation and further decreasing the risk of atelectasis
Several studies have investigated these available devices and compared their efficacy in lowering reintubation rates after extubation but results are conflicting and inconsistent and no study could conclude that either HFNC NIV or COT is superior to prevent reintubation One randomized controlled trial RCT reported that HFNC was associated with a lower rate of reintubation in low-risk patients compared to COT Another RCT in high-risk non-hypercapnic patients and concluded that HFNC could not decrease rate of reintubation compared with COT A third study showed that HFNC and NIV are equally effective in lowering reintubation rate
In Egypt researchers have also studied and compared the effectiveness of these modalities in different clinical ICU settings with comparable efficacies between three devices The objective of the current work is to compare the rate of reintubation after extubation using HFNC versus NIV and COT as sequential respiratory support
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None