Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05487573
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-08-15
First Post:
2022-08-02
Brief Title:
Performance of the Variation in Arterial Lactatemia During a Spontaneous Breathing Trial SBT in the Prediction of Extubation Failure
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Performance of the Variation in Arterial Lactatemia During a Spontaneous Breathing Trial SBT in the Prediction of Extubation Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-07
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:
PREDILACT
Brief Summary:
Extubation failure EF is independently associated with excess mortality of critically ill patients To avoid EF critically ill patients being weaned from invasive mechanical ventilation IMV perform spontaneous breathing trial SBT which is the litmus test for determining the ability to breathe without a ventilator
Thus the performance of the SBT during weaning from IMV to predict successful extubation is crucial The investigators hypothesize that patients with EF increase arterial lactate concentration during SBT due to increased work of breathing and hypoxia
The aim of this study is to evaluate the performance of variation in arterial lactate concentration before and after SBT in predicting successful extubation in critically ill patients
Thus the performance of the SBT during weaning from IMV to predict successful extubation is crucial The investigators hypothesize that patients with EF increase arterial lactate concentration during SBT due to increased work of breathing and hypoxia
The aim of this study is to evaluate the performance of variation in arterial lactate concentration before and after SBT in predicting successful extubation in critically ill patients
Detailed Description:
Extubation failure EF is defined as the need for reintubation within 48-72 hour This complication is independently associated with a seven-fold increased risk of death in critically ill patients
To avoid EF critically ill patients being weaned from invasive mechanical ventilation IMV perform spontaneous breathing trial SBT which is the litmus test for determining the ability to breathe without a ventilator However EF occurs in 10 to 20 of patients despite having successful SBT
Thus the performance of the SBT during weaning from IMV to predict successful extubation is crucial
Previous studies of predictive markers of EF have been performed primarily to assess weaning failure from cardiac origin
The investigators hypothesize that critically ill patients who are going to have EF increase arterial lactate concentration during SBT due to increased work of breathing and hypoxia regardless of the cause of failure
The aim of this study is to evaluate the performance of variation in arterial lactate concentration before and after SBT in predicting successful extubation in critically ill patients
To avoid EF critically ill patients being weaned from invasive mechanical ventilation IMV perform spontaneous breathing trial SBT which is the litmus test for determining the ability to breathe without a ventilator However EF occurs in 10 to 20 of patients despite having successful SBT
Thus the performance of the SBT during weaning from IMV to predict successful extubation is crucial
Previous studies of predictive markers of EF have been performed primarily to assess weaning failure from cardiac origin
The investigators hypothesize that critically ill patients who are going to have EF increase arterial lactate concentration during SBT due to increased work of breathing and hypoxia regardless of the cause of failure
The aim of this study is to evaluate the performance of variation in arterial lactate concentration before and after SBT in predicting successful extubation in critically ill patients
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