Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758546
Status:
COMPLETED
Last Update Posted:
2023-04-06
First Post:
2021-02-11
Brief Title:
Speeding the Weaning up Aggressive Screening Criteria and Higher Minimal Ventilatory Settings
Sponsor:
Gonzalo Hernandez Martinez
Organization:
Hospital Virgen de la Salud
Study Overview
Official Title:
Customizing Spontaneous Breathing Trial After Aggressive Readiness Criteria Hastens Weaning in Low and Intermediate Risk Patients With Prevention A Randomized Trial SPEED-UP Trial
Status:
COMPLETED
Status Verified Date:
2023-04
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:
SPEED-UP
Brief Summary:
Hypothesis
1 In patients with less than 4 high risk factors for reintubation excluding body mass index 30 and hypercapnia during the spontaneous breathing trial SBT low and intermediate risk for extubation failure who receive preventive therapy with high flow nasal cannula HFNC the use of SBT with HIGH minimal ventilator settings PS 8 PEEP 5 cm H2O Vs PS 5 PEEP 0 cm H2O increase the proportion of patients with simple weaning extubation after the first SBT
2 In patients with low and intermediate risk for extubation failure who receive preventive therapy with HFNC the use of Walsh screening criteria reduces the mechanical ventilation time compared with the use of Boles criteria
Study design This is a multicenter randomized open trial with 4 arms
1 Screening with PaO2FiO2 180 and PEEP 10cm H2O SBT with HIGH minimal ventilator settings PS 8 PEEP 5 cm H2O
2 Screening with PaO2FiO2 180 and PEEP 10 cm H2O SBT with LOW minimal ventilator settings PS 5 PEEP 0 cm H2O
3 Screening with PaO2FiO2 150 and PEEP 8 cm H2O SBT with HIGH minimal ventilator settings PS 8 PEEP 5 cm H2O
4 Screening with PaO2FiO2 150 and PEEP 8 cm H2O SBT with LOW minimal ventilator settings PS 5 PEEP 0 cm H2O
Primary Outcome Measure
1 - Percentage of first spontaneous breathing trial tolerated
2 - Time on mechanical ventilation
1 In patients with less than 4 high risk factors for reintubation excluding body mass index 30 and hypercapnia during the spontaneous breathing trial SBT low and intermediate risk for extubation failure who receive preventive therapy with high flow nasal cannula HFNC the use of SBT with HIGH minimal ventilator settings PS 8 PEEP 5 cm H2O Vs PS 5 PEEP 0 cm H2O increase the proportion of patients with simple weaning extubation after the first SBT
2 In patients with low and intermediate risk for extubation failure who receive preventive therapy with HFNC the use of Walsh screening criteria reduces the mechanical ventilation time compared with the use of Boles criteria
Study design This is a multicenter randomized open trial with 4 arms
1 Screening with PaO2FiO2 180 and PEEP 10cm H2O SBT with HIGH minimal ventilator settings PS 8 PEEP 5 cm H2O
2 Screening with PaO2FiO2 180 and PEEP 10 cm H2O SBT with LOW minimal ventilator settings PS 5 PEEP 0 cm H2O
3 Screening with PaO2FiO2 150 and PEEP 8 cm H2O SBT with HIGH minimal ventilator settings PS 8 PEEP 5 cm H2O
4 Screening with PaO2FiO2 150 and PEEP 8 cm H2O SBT with LOW minimal ventilator settings PS 5 PEEP 0 cm H2O
Primary Outcome Measure
1 - Percentage of first spontaneous breathing trial tolerated
2 - Time on mechanical ventilation
Detailed Description:
Discontinuation of mechanical ventilation is a three-step process including
1 - Readiness testing
It evaluates the criteria to determine whether a patient might be able to be successfully and safety weaned from mechanical ventilation The detection of readiness to try a spontaneous breathing test has controversial questions in special concerning to oxygenation From a conservative to an aggressive criteria we can list
1 PaO2FiO2 200 on PEEP 5 cm H2O Esteban et al 1999
2 PaO2FiO2 150 on PEEP 8 cm H2O Boles et al 2007
3 PaO2FiO2 180 on PEEP 10 cm H2O Walsh et al 2004 We will compare Walsh and Boles in their different considerations for oxygenation criteria Since Walsh criteria require a higher level of PEEP we understand that this criteria is more aggressive and in this way it allow to an early detection of readiness to SBT but there is not any evidence of this statement
2 - Spontaneous breathing trial SBT It tries to simulate but not only post-extubation work of breathing to promptly determine the time to extubation There is also disparity about SBT minimal ventilator settings
1 Inspiratory pressure with a range between automatic tube compensation ATC and inspiratory pressure of 5 - 8 cm H2O Theoretically if we use a higher support pressure during SBT it would be easier to pass the test One could think that this may rise the risk of reintubation but there are various trials that have not confirmed this assumption
2 Guidelines does not make any recommendation about expiratory pressurization although the trials conducted use levels of Positive End-Expiratory Pressure PEEP between 0 and 5 cm H2O
3 Furthermore we consider that minimal ventilator settings must be adjusted to additional parameters not previously considered like preventive therapy applied after the extubation
4 All spontaneous breathing trials will last 30 minutes
3 - Extubation follow-up care Therapies targeted to prevent post-extubation respiratory failure like high flow nasal cannula HFNC noninvasive ventilation NIV and respiratory physiotherapy for improving airway clearance have been proposed
The variability of preventive therapies and its settings generate different minimal ventilator settings
In view of all that has been set out above there are two essential points that has not been analyzed as far we understand
1 The different screening criteria available have not been compared with each other about allowing early detection of readiness even less with the individual risk of postextubation failure and still less with the preventive therapy that would be applied for each group
2 The different inspiratory support pressure as well as PEEP level have not been compared with other different values even less with the individual risk of postextubation failure and still less with the preventive therapy that would be applied for each group
The detailed weaning criteria include the following
Clinical evaluation
Adequate cough reflex and good clearance of respiratory secretions
Resolution or stabilization of the initial reason for intubation
Patient awake with RASS between 1 and -2 according the Richmond Assessment Sedation Scale RASS
Data evaluation
Cardiovascular stability with minimal or no need of vasopressors HR 140 lpm blood systolic pressure between 90-160 mmHg with minimal or no need of vasopressors and without increase in the last 24 hours
Successful oxygenation defined by SpO2 90 on FiO2 40 or PaO2FiO2
150 with PEEP up to 8 cmH2O Boles et al 2007 or PaO2FiO2 180 con PEEP 10 cm H2O Walsh et al 2004
Respiratory rate 35 bpm without respiratory acidosis
Hemoglobin 7gdL
Temperature between 36-385ºC
Blood potassium between 3-5 mmolL
Blood sodium between 128-150 mmolL
Detailed definition of high risk factors for extubation failure age older than 65 years heart failure as the primary indication for mechanical ventilation moderate to severe chronic obstructive pulmonary disease an Acute Physiology and Chronic Health Evaluation II APACHE II score higher than 12 on extubation day body mass index of more than 30 calculated as weight in kilograms divided by height in meters squared airway patency problems including high risk of developing laryngeal edema inability to deal with respiratory secretions inadequate cough reflex or suctioning 2 times within 8 hours before extubation difficult or prolonged weaning in brief a patient failing the first attempt at disconnection from mechanical ventilation 2 or more comorbidities defined with Charlson score and mechanical ventilation for more than 7 days
The detailed risk categories are the following
Low risk Patients without risk factors who benefit from HFNC
Intermediate risk Patients with 1 to 3 risk factors excluding obese BMI 30 Kgm2 and those who develop hypercapnia during the SBT that can benefit from HFNC
High risk Obese BMI 30 Kgm2 and patients with 4 or more risk factors including hypercapnia during the SBT This group may benefit from prevention with NIV
Sample size estimation
Basal parameters in low risk patients treated with post-extubation HFNC estimated 30 of the entire population Reintubation rate 49 and 11-3 days on mechanical ventilation Estimated reduction in the intervention group 1 day in the 25 of the patients
Basal parameters in intermediate risk patients treated with HFNC estimated 70 of the entire population Reintubation rate 1224 and 4 2 - 9 days on mechanical ventilation Estimated reduction 1 day in the 33 of the patients
Calculated standard deviation 35 days CI 95 and power 80 loss rate 10 and one-tail analysis 260 patients per group
Simple randomization immediately after finishing the spontaneous breathing trial An intention to treat analysis will be performed
Detailed HFNC treatment High-flow oxygen Optiflow Fisher and Paykel Healthcare will be applied immediately after extubation through specific nasal cannula Flow will be initially set at 10 Lmin and titrated upwards in 5-Lmin steps until patients experience discomfort Temperature will be initially set to 37C unless reported too hot by patients and FIO2 will be regularly adjusted to the target peripheral capillary oxygen saturation SPO2 of greater than 92 After 48 hours high-flow will be stopped and if necessary patients will receive conventional oxygen therapy
Criteria for spontaneous breathing trial failure are agitation anxiety depressed mental status diaphoresis cyanosis evidence of increasing respiratory effort increased accessory muscle activity facial signs of distress dyspnea PaO2 lower than 60 mmHg or SpO2 lower than 90 on inspired fraction of oxygen higher than 5 PaCO2 higher than 50 mmHg or increased more than 8 mmHg from baseline value arterial pH lower than 732 or decreased more than 07 from baseline value respiratory rate higher than 35 breaths per minute or increased more than 50 from baseline value heart rate higher than 140 beats per minute or increased more than 20 from baseline value systolic arterial pressure higher than 180 mmHg or increased more than 20 from baseline value systolic arterial pressure lower than 90 mmHg or cardiac arrhythmias
Patients who tolerate the spontaneous breathing trial will be reconnected with the previous ventilator settings for rest and clinical evaluation of airway patency respiratory secretions and upper airway obstruction before extubation
1 - Readiness testing
It evaluates the criteria to determine whether a patient might be able to be successfully and safety weaned from mechanical ventilation The detection of readiness to try a spontaneous breathing test has controversial questions in special concerning to oxygenation From a conservative to an aggressive criteria we can list
1 PaO2FiO2 200 on PEEP 5 cm H2O Esteban et al 1999
2 PaO2FiO2 150 on PEEP 8 cm H2O Boles et al 2007
3 PaO2FiO2 180 on PEEP 10 cm H2O Walsh et al 2004 We will compare Walsh and Boles in their different considerations for oxygenation criteria Since Walsh criteria require a higher level of PEEP we understand that this criteria is more aggressive and in this way it allow to an early detection of readiness to SBT but there is not any evidence of this statement
2 - Spontaneous breathing trial SBT It tries to simulate but not only post-extubation work of breathing to promptly determine the time to extubation There is also disparity about SBT minimal ventilator settings
1 Inspiratory pressure with a range between automatic tube compensation ATC and inspiratory pressure of 5 - 8 cm H2O Theoretically if we use a higher support pressure during SBT it would be easier to pass the test One could think that this may rise the risk of reintubation but there are various trials that have not confirmed this assumption
2 Guidelines does not make any recommendation about expiratory pressurization although the trials conducted use levels of Positive End-Expiratory Pressure PEEP between 0 and 5 cm H2O
3 Furthermore we consider that minimal ventilator settings must be adjusted to additional parameters not previously considered like preventive therapy applied after the extubation
4 All spontaneous breathing trials will last 30 minutes
3 - Extubation follow-up care Therapies targeted to prevent post-extubation respiratory failure like high flow nasal cannula HFNC noninvasive ventilation NIV and respiratory physiotherapy for improving airway clearance have been proposed
The variability of preventive therapies and its settings generate different minimal ventilator settings
In view of all that has been set out above there are two essential points that has not been analyzed as far we understand
1 The different screening criteria available have not been compared with each other about allowing early detection of readiness even less with the individual risk of postextubation failure and still less with the preventive therapy that would be applied for each group
2 The different inspiratory support pressure as well as PEEP level have not been compared with other different values even less with the individual risk of postextubation failure and still less with the preventive therapy that would be applied for each group
The detailed weaning criteria include the following
Clinical evaluation
Adequate cough reflex and good clearance of respiratory secretions
Resolution or stabilization of the initial reason for intubation
Patient awake with RASS between 1 and -2 according the Richmond Assessment Sedation Scale RASS
Data evaluation
Cardiovascular stability with minimal or no need of vasopressors HR 140 lpm blood systolic pressure between 90-160 mmHg with minimal or no need of vasopressors and without increase in the last 24 hours
Successful oxygenation defined by SpO2 90 on FiO2 40 or PaO2FiO2
150 with PEEP up to 8 cmH2O Boles et al 2007 or PaO2FiO2 180 con PEEP 10 cm H2O Walsh et al 2004
Respiratory rate 35 bpm without respiratory acidosis
Hemoglobin 7gdL
Temperature between 36-385ºC
Blood potassium between 3-5 mmolL
Blood sodium between 128-150 mmolL
Detailed definition of high risk factors for extubation failure age older than 65 years heart failure as the primary indication for mechanical ventilation moderate to severe chronic obstructive pulmonary disease an Acute Physiology and Chronic Health Evaluation II APACHE II score higher than 12 on extubation day body mass index of more than 30 calculated as weight in kilograms divided by height in meters squared airway patency problems including high risk of developing laryngeal edema inability to deal with respiratory secretions inadequate cough reflex or suctioning 2 times within 8 hours before extubation difficult or prolonged weaning in brief a patient failing the first attempt at disconnection from mechanical ventilation 2 or more comorbidities defined with Charlson score and mechanical ventilation for more than 7 days
The detailed risk categories are the following
Low risk Patients without risk factors who benefit from HFNC
Intermediate risk Patients with 1 to 3 risk factors excluding obese BMI 30 Kgm2 and those who develop hypercapnia during the SBT that can benefit from HFNC
High risk Obese BMI 30 Kgm2 and patients with 4 or more risk factors including hypercapnia during the SBT This group may benefit from prevention with NIV
Sample size estimation
Basal parameters in low risk patients treated with post-extubation HFNC estimated 30 of the entire population Reintubation rate 49 and 11-3 days on mechanical ventilation Estimated reduction in the intervention group 1 day in the 25 of the patients
Basal parameters in intermediate risk patients treated with HFNC estimated 70 of the entire population Reintubation rate 1224 and 4 2 - 9 days on mechanical ventilation Estimated reduction 1 day in the 33 of the patients
Calculated standard deviation 35 days CI 95 and power 80 loss rate 10 and one-tail analysis 260 patients per group
Simple randomization immediately after finishing the spontaneous breathing trial An intention to treat analysis will be performed
Detailed HFNC treatment High-flow oxygen Optiflow Fisher and Paykel Healthcare will be applied immediately after extubation through specific nasal cannula Flow will be initially set at 10 Lmin and titrated upwards in 5-Lmin steps until patients experience discomfort Temperature will be initially set to 37C unless reported too hot by patients and FIO2 will be regularly adjusted to the target peripheral capillary oxygen saturation SPO2 of greater than 92 After 48 hours high-flow will be stopped and if necessary patients will receive conventional oxygen therapy
Criteria for spontaneous breathing trial failure are agitation anxiety depressed mental status diaphoresis cyanosis evidence of increasing respiratory effort increased accessory muscle activity facial signs of distress dyspnea PaO2 lower than 60 mmHg or SpO2 lower than 90 on inspired fraction of oxygen higher than 5 PaCO2 higher than 50 mmHg or increased more than 8 mmHg from baseline value arterial pH lower than 732 or decreased more than 07 from baseline value respiratory rate higher than 35 breaths per minute or increased more than 50 from baseline value heart rate higher than 140 beats per minute or increased more than 20 from baseline value systolic arterial pressure higher than 180 mmHg or increased more than 20 from baseline value systolic arterial pressure lower than 90 mmHg or cardiac arrhythmias
Patients who tolerate the spontaneous breathing trial will be reconnected with the previous ventilator settings for rest and clinical evaluation of airway patency respiratory secretions and upper airway obstruction before extubation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None