Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502489
Status:
UNKNOWN
Last Update Posted:
2007-07-17
First Post:
2007-07-15
Brief Title:
Computer Driven Management of Weaning Following Prolonged Mechanical Ventilation
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Computer Driven Management of Weaning Following Prolonged Mechanical Ventilation a Pilot Study
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
NOT_YET_RECRUITING
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:
After an episode of acute respiratory failure requiring mechanical ventilation weaning the patient from the ventilator may be difficult Discontinuation of ventilation is estimated to take up to 40 of the total duration of ventilatory support Approximately two- thirds of patients can be disconnected from the ventilator after a spontaneous breathing trial Prolongation of mechanical ventilation may increase the risk of adverse events such as infections and can increase morbidity and mortality
Identifying weaning readiness early and reliably is therefore crucial Weaning protocols developed to assist in identifying weaning readiness have been shown to shorten duration of mechanical ventilation most notably the weaning period
Closed loop knowledge-based systems serve as a continuously applied weaning process that automatically reduce ventilatory assistance according to patient ability and indicate when the patient is ready for disconnection No data on the use of such a computer driven system CDS in elderly patients requiring prolonged ventilation in weaning centers non ICU have been reported
The Objective of the present study is to evaluate the ability of a computer driven system to predict weaning readiness and to compare this to a physician-directed protocol The CDS continuously adapts pressure support gradually decreasing ventilator assistance according to patient ability and thus indicates weaning readiness Patients who maintain spontaneous breathing for 7 days following weaning will be considered to be successfully weaned from mechanical ventilation
Identifying weaning readiness early and reliably is therefore crucial Weaning protocols developed to assist in identifying weaning readiness have been shown to shorten duration of mechanical ventilation most notably the weaning period
Closed loop knowledge-based systems serve as a continuously applied weaning process that automatically reduce ventilatory assistance according to patient ability and indicate when the patient is ready for disconnection No data on the use of such a computer driven system CDS in elderly patients requiring prolonged ventilation in weaning centers non ICU have been reported
The Objective of the present study is to evaluate the ability of a computer driven system to predict weaning readiness and to compare this to a physician-directed protocol The CDS continuously adapts pressure support gradually decreasing ventilator assistance according to patient ability and thus indicates weaning readiness Patients who maintain spontaneous breathing for 7 days following weaning will be considered to be successfully weaned from mechanical ventilation
Detailed Description:
Introduction
After an episode of acute respiratory failure requiring mechanical ventilation weaning the patient from the ventilator may be difficult Discontinuation of ventilation is estimated to take up to 40 of the total duration of ventilatory support Approximately two- thirds of patients can be disconnected from the ventilator after a spontaneous breathing trial Prolongation of mechanical ventilation may increase the risk of adverse events such as infections and can increase morbidity and mortality
Identifying weaning readiness early and reliably is therefore crucial Weaning protocols developed to assist in identifying weaning readiness have been shown to shorten duration of mechanical ventilation most notably the weaning period
Closed loop knowledge-based systems serve as a continuously applied weaning process that automatically reduce ventilatory assistance according to patient ability and indicate when the patient is ready for disconnection No data on the use of such a computer driven system CDS in elderly patients requiring prolonged ventilation in weaning centers non ICU have been reported
Objective
To evaluate the ability of a computer driven system to predict weaning readiness and to compare this to a physician-directed protocol The CDS continuously adapts pressure support gradually decreasing ventilator assistance according to patient ability and thus indicates weaning readiness Patients who maintain spontaneous breathing for 7 days following weaning will be considered to be successfully weaned from mechanical ventilation
Design and setting
A single center randomized controlled clinical study at the Beit Rivka regional weaning center RWC
Patients
This study will be conducted at the Beit Rivka geriatric rehabilitation hospital Petah Tikva Written informed consent will be obtained from the patient or legal representative The study will include 60 consecutive patients who meet all inclusion criteria after stabilization of the acute health problems that prompted admission to the referral hospital Inclusion criteria are as follows pressure support ventilation PSV for at least 48 h plateau pressure less than 30 cmH2O PEEP 6 cmH2O PaO2FIO2 ratio 150 or SaO2 94 with FIO2 than 05 pCO2 55 mm Hg for normal patients and 65 m Hg for patients with COPD no requirement for inotropic support body temperature 3650C and 3850 C stable neurological status with Glasgow Coma Score GCS 6 HgB 8 mg systolic blood pressure 90 mg Hg mean arterial pressure 65 mg Hg absence of sedative medications and availability of CDS at the time of patient admission or switching to pressure support ventilation PSV Patients younger than 60 or older than 85 years of age patients on chronic ventilatory assistance at home and patients with decision to limit life-sustaining treatments will be excluded
Treatment group assignment will be by a sealed envelope upon admission to the hospital Attending doctors will not be blinded as to the treatment groups
Description of the computer driven system
The CDS is a knowledge- based system embedded in a ventilator EVITA XL 15 16 17 It achieves three main goals First the CDS continuously adjusts the PSV level based on respiratory rate RR tidal volume Vt and end-tidal partial pressure of CO2 PETCO2 acquired from the ventilator in real time and averaged over 2 min Adjustment is such that the patient is kept within a comfort zone defined as a RR between 15-30 range up to 34 within patients with neurological disorders Vt greater than 300 ml 250 ml if body weight 55 kg and PETCO-2 less than 55 mm Hg 65 mmHg in patients with COPD Second the CDS gradually decreases ventilatory assistance by reducing PSV level after at least 30 min of stable ventilation within the comfort zone the reduction is by 2 or 4 cm H20 depending on whether the initial level is below or above 20 cm H2O respectively Third the CDS evaluates weaning readiness when the PSV level reaches the preset minimal value 9 cm H2O in tracheotomized patients the CDS starts an observational period which serves as automatic spontaneous breathing trial After uninterrupted ventilation at the minimal PSV level for 1 or 2 h depending on whether the initial PSV level was above or below 15 cm H2O the CDS displays a message that the patient is ready to be disconnected from the ventilator The investigator will have perfect knowledge of the system
Prediction of weaning Weaning readiness as evaluated by the CDS and by the internist will be recorded daily ie every morning between 10 and 11 am The decision will be considered to be taken by the CDS before the physician when it was taken 1 day in advance ie the preceding morning Physicians will be aware of the PSV level delivered by the CDS and could take this level into account in their evaluation Weaning protocols used routinely in the center recommend a daily assessment for weaning similar to that used by the CDS Patients are declared weaned as soon as the physician or CDS predicts weaning readiness The control group reflects the standard of care before CDS implementation PS of 10 cm H2O or higher is set manually After 20 min in the absence of signs of poor tolerance the PSV is reduced by 4 or 2 cm H20 depending on initial PSV level or 20 If poor tolerance to weaning is evident the progression of the weaning is stopped and the patient is reassessed 20 min later for further reduction in PSV The PSV level is decreased to 9 cm H2O In the case of apnea SIMV is reinstituted If the evaluation is satisfactory the patient is disconnected from the ventilator The patient is closely monitored for signs of respiratory failure requiring reinstitution of mechanical ventilation as well as for occurrence of any other complications RWC length of stay on MV will be recorded
Clinical characteristics including age sex anthropometrical data APACHE II score Functional Independence Measure FIM Mini Mental State Examination MMSE Geriatric Depression Scale GDS Mini Nutritional Assessment MNA temperature ny concomitant medications hand grip strength will be recorded
Expired tidal volume respiratory rate Peak airway pressure mean airway pressure Compliance Resistance respiratory frequency to tidal volume ratio fVt Negative Inspiratory Pressure NIP Maximal Inspiratory Pressure MIP Minute Ventilation MVinspiratory time will be recorded
Other elements relevant to mechanical ventilation management include arterial blood gas estimation the number of changes in the settings of the ventilator performed by the health care workers the number of transitions from controlled to assisted ventilation and the number of apnea and high pressure alarms
The primary outcome variables will be the duration of mechanical ventilation
Discontinuation from MV will be attempted when the primary physician judges that the patient is ready to be weaned according to the standard criteria Mechanical ventilation will be reinstituted in the following circumstances respiratory rate above 35 breaths min P02 below 65 mm Hg with FIO2less than 06 ph 734 or less heart rate equal to or above 1 10 beats min or Increased by 20 or more or if arrhythmias appear systolic blood pressure without inotropes 90 mmHg or above 20 of usual blood pressure uncoordinated thoraco-abdominal movements activation of accessory muscles agitation or depressed mental status or excessive sweating
A weaning trial will be considered a failure when the patient will be not tolerate the weaning trial patients still in the use CDW at day 60 and patients requires reconnection to MV Weaning trial will be considered successful if spontaneous breathing is sustained for more than 168 h 7 days after disconnection from MV
After an episode of acute respiratory failure requiring mechanical ventilation weaning the patient from the ventilator may be difficult Discontinuation of ventilation is estimated to take up to 40 of the total duration of ventilatory support Approximately two- thirds of patients can be disconnected from the ventilator after a spontaneous breathing trial Prolongation of mechanical ventilation may increase the risk of adverse events such as infections and can increase morbidity and mortality
Identifying weaning readiness early and reliably is therefore crucial Weaning protocols developed to assist in identifying weaning readiness have been shown to shorten duration of mechanical ventilation most notably the weaning period
Closed loop knowledge-based systems serve as a continuously applied weaning process that automatically reduce ventilatory assistance according to patient ability and indicate when the patient is ready for disconnection No data on the use of such a computer driven system CDS in elderly patients requiring prolonged ventilation in weaning centers non ICU have been reported
Objective
To evaluate the ability of a computer driven system to predict weaning readiness and to compare this to a physician-directed protocol The CDS continuously adapts pressure support gradually decreasing ventilator assistance according to patient ability and thus indicates weaning readiness Patients who maintain spontaneous breathing for 7 days following weaning will be considered to be successfully weaned from mechanical ventilation
Design and setting
A single center randomized controlled clinical study at the Beit Rivka regional weaning center RWC
Patients
This study will be conducted at the Beit Rivka geriatric rehabilitation hospital Petah Tikva Written informed consent will be obtained from the patient or legal representative The study will include 60 consecutive patients who meet all inclusion criteria after stabilization of the acute health problems that prompted admission to the referral hospital Inclusion criteria are as follows pressure support ventilation PSV for at least 48 h plateau pressure less than 30 cmH2O PEEP 6 cmH2O PaO2FIO2 ratio 150 or SaO2 94 with FIO2 than 05 pCO2 55 mm Hg for normal patients and 65 m Hg for patients with COPD no requirement for inotropic support body temperature 3650C and 3850 C stable neurological status with Glasgow Coma Score GCS 6 HgB 8 mg systolic blood pressure 90 mg Hg mean arterial pressure 65 mg Hg absence of sedative medications and availability of CDS at the time of patient admission or switching to pressure support ventilation PSV Patients younger than 60 or older than 85 years of age patients on chronic ventilatory assistance at home and patients with decision to limit life-sustaining treatments will be excluded
Treatment group assignment will be by a sealed envelope upon admission to the hospital Attending doctors will not be blinded as to the treatment groups
Description of the computer driven system
The CDS is a knowledge- based system embedded in a ventilator EVITA XL 15 16 17 It achieves three main goals First the CDS continuously adjusts the PSV level based on respiratory rate RR tidal volume Vt and end-tidal partial pressure of CO2 PETCO2 acquired from the ventilator in real time and averaged over 2 min Adjustment is such that the patient is kept within a comfort zone defined as a RR between 15-30 range up to 34 within patients with neurological disorders Vt greater than 300 ml 250 ml if body weight 55 kg and PETCO-2 less than 55 mm Hg 65 mmHg in patients with COPD Second the CDS gradually decreases ventilatory assistance by reducing PSV level after at least 30 min of stable ventilation within the comfort zone the reduction is by 2 or 4 cm H20 depending on whether the initial level is below or above 20 cm H2O respectively Third the CDS evaluates weaning readiness when the PSV level reaches the preset minimal value 9 cm H2O in tracheotomized patients the CDS starts an observational period which serves as automatic spontaneous breathing trial After uninterrupted ventilation at the minimal PSV level for 1 or 2 h depending on whether the initial PSV level was above or below 15 cm H2O the CDS displays a message that the patient is ready to be disconnected from the ventilator The investigator will have perfect knowledge of the system
Prediction of weaning Weaning readiness as evaluated by the CDS and by the internist will be recorded daily ie every morning between 10 and 11 am The decision will be considered to be taken by the CDS before the physician when it was taken 1 day in advance ie the preceding morning Physicians will be aware of the PSV level delivered by the CDS and could take this level into account in their evaluation Weaning protocols used routinely in the center recommend a daily assessment for weaning similar to that used by the CDS Patients are declared weaned as soon as the physician or CDS predicts weaning readiness The control group reflects the standard of care before CDS implementation PS of 10 cm H2O or higher is set manually After 20 min in the absence of signs of poor tolerance the PSV is reduced by 4 or 2 cm H20 depending on initial PSV level or 20 If poor tolerance to weaning is evident the progression of the weaning is stopped and the patient is reassessed 20 min later for further reduction in PSV The PSV level is decreased to 9 cm H2O In the case of apnea SIMV is reinstituted If the evaluation is satisfactory the patient is disconnected from the ventilator The patient is closely monitored for signs of respiratory failure requiring reinstitution of mechanical ventilation as well as for occurrence of any other complications RWC length of stay on MV will be recorded
Clinical characteristics including age sex anthropometrical data APACHE II score Functional Independence Measure FIM Mini Mental State Examination MMSE Geriatric Depression Scale GDS Mini Nutritional Assessment MNA temperature ny concomitant medications hand grip strength will be recorded
Expired tidal volume respiratory rate Peak airway pressure mean airway pressure Compliance Resistance respiratory frequency to tidal volume ratio fVt Negative Inspiratory Pressure NIP Maximal Inspiratory Pressure MIP Minute Ventilation MVinspiratory time will be recorded
Other elements relevant to mechanical ventilation management include arterial blood gas estimation the number of changes in the settings of the ventilator performed by the health care workers the number of transitions from controlled to assisted ventilation and the number of apnea and high pressure alarms
The primary outcome variables will be the duration of mechanical ventilation
Discontinuation from MV will be attempted when the primary physician judges that the patient is ready to be weaned according to the standard criteria Mechanical ventilation will be reinstituted in the following circumstances respiratory rate above 35 breaths min P02 below 65 mm Hg with FIO2less than 06 ph 734 or less heart rate equal to or above 1 10 beats min or Increased by 20 or more or if arrhythmias appear systolic blood pressure without inotropes 90 mmHg or above 20 of usual blood pressure uncoordinated thoraco-abdominal movements activation of accessory muscles agitation or depressed mental status or excessive sweating
A weaning trial will be considered a failure when the patient will be not tolerate the weaning trial patients still in the use CDW at day 60 and patients requires reconnection to MV Weaning trial will be considered successful if spontaneous breathing is sustained for more than 168 h 7 days after disconnection from MV
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