Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391424
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2023-12-15
Brief Title:
Oxygen Consumption VO2 Effort and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit ICU
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Oxygen Consumption VO2 Effort and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit ICU EXTUBATE Study
Status:
RECRUITING
Status Verified Date:
2024-09
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:
EXTUBATE
Brief Summary:
In patients who are mechanically ventilated for more than 72 hours weaning failure is a common issue The Spontaneous breathing trial SBT is often done to assess if the patient can be extubated with a high chance of success However re-intubation rates are between 15 - 20 after a successful SBT The rapid shallow breathing index RSBI is an important parameter used in an SBT Because the high incidence of extubation failure re-intubation within 48 hours a search for a better parameter than the RSBI is warranted Using the measured end-tidal oxygen etO2 of mechanically ventilated patients it is possible to calculate the VO2 which is a measure of patient effort The VO2 is a parameter with the potential to predict weaning success or failure together with other parameters of patient effort like the work of breathing WOB pressure time product PTP and esophageal pressure swings reflecting muscle strength of the diaphragm Therefore the investigators want to investigate if these parameters are associated with an SBT success or failure
Detailed Description:
Weaning failure is a common problem in patients who are mechanically ventilated for more than 72 hours Prediction of successful extubation is crucial for mechanically ventilated MV intensive care patients Prolonged intubation leads to prolonged mechanical ventilation which is known to have undesirable and detrimental effects Premature extubation on the other hand is associated with clinical deterioration a second episode of mechanical ventilation and prolonged mechanical ventilation resulting in multiple adverse outcomes
In addition up to 20 of all Intensive Care Unit ICU patients fail to wean from mechanical ventilation Prolonged mechanical ventilation is associated with half of the total time spent on the ICU Improving the prediction of successful weaning provides physicians with a mean to optimize extubation timing while reducing the incidence of premature extubation
The rapid shallow breathing index RSBI is a parameter commonly used to predict extubation success next to some other clinical parameters such as consciousness level the ability to cough and muscle strength The most commonly used RSBI cut-off value for predicting save extubation incorrectly classifies 15 to 20 of patients Which means that those patients require another period of mechanical ventilation with possible adverse consequences It is therefore necessary to develop new parameters or indices aiding in the guidance of extubation timing
Various other parameters such as work of breathing WOB transpulmonary pressure swings PS and the pressure time product PTP which are manifestations of patient effort have been investigated Although a difference in transpulmonary pressure swings during a spontaneous breathing trial SBT has been linked to weaning failure it has yet to be determined whether transpulmonary pressure swings predict extubation success or failure For all these measures of effort the placement of an esophageal catheter is obligatory
Oxygen consumption VO2 is a direct manifestation of patient effort It is defined as the difference between the amount of oxygen inhaled and exhaled over a predetermined time interval Using end tidal oxygen etO2 measurements and volumetric calculations it is feasible to track VO2 variations breath-by-breath A change in oxygen consumption during an SBT could be an early indicator of patient effort and failure
The investigators hypothesize that VO2 measurement together with indices of patient effort could be valuable additional parameters when estimating weaning failure or success and therefore aid in the prediction of extubation success or failure
In addition up to 20 of all Intensive Care Unit ICU patients fail to wean from mechanical ventilation Prolonged mechanical ventilation is associated with half of the total time spent on the ICU Improving the prediction of successful weaning provides physicians with a mean to optimize extubation timing while reducing the incidence of premature extubation
The rapid shallow breathing index RSBI is a parameter commonly used to predict extubation success next to some other clinical parameters such as consciousness level the ability to cough and muscle strength The most commonly used RSBI cut-off value for predicting save extubation incorrectly classifies 15 to 20 of patients Which means that those patients require another period of mechanical ventilation with possible adverse consequences It is therefore necessary to develop new parameters or indices aiding in the guidance of extubation timing
Various other parameters such as work of breathing WOB transpulmonary pressure swings PS and the pressure time product PTP which are manifestations of patient effort have been investigated Although a difference in transpulmonary pressure swings during a spontaneous breathing trial SBT has been linked to weaning failure it has yet to be determined whether transpulmonary pressure swings predict extubation success or failure For all these measures of effort the placement of an esophageal catheter is obligatory
Oxygen consumption VO2 is a direct manifestation of patient effort It is defined as the difference between the amount of oxygen inhaled and exhaled over a predetermined time interval Using end tidal oxygen etO2 measurements and volumetric calculations it is feasible to track VO2 variations breath-by-breath A change in oxygen consumption during an SBT could be an early indicator of patient effort and failure
The investigators hypothesize that VO2 measurement together with indices of patient effort could be valuable additional parameters when estimating weaning failure or success and therefore aid in the prediction of extubation success or failure
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