Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598709
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
International Survey for EXTubation Evaluation and Respiratory Dynamics in Acute Respiratory Distress Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
International Survey for EXTubation Evaluation and Respiratory Dynamics in Acute Respiratory Distress Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
EXTEND ARDS
Brief Summary:
EXTEND ARDS study is an international survey for ventilator weaning and extubation among ARDS patients This study will be conducted on behalf of the Japanese ARDS Clinical Practice Guideline 2024 Committee as well as endorsement of the Japanese Society of Intensive Care Medicine the Japanese Respiratory Society and the Japanese Society of Respiratory Care Medicine This survey aims to prospectively collect the clinical data of mechanically ventilated ARDS patients related with ventilator weaning and extubation internationally as well as the outcome of ARDS patients with extubation failure This study also aims to identify predictive factors strongly associated with extubation failure The contents of mechanical ventilation settings respiratory conditions and blood examination data will be collected
Detailed Description:
11 Background
Acute respiratory distress syndrome ARDS is a life-threatening condition characterized by widespread inflammatory lung injury and is encountered in an estimated 23 of mechanically ventilated patients 1 Recent studies reported that the mortality of mechanically ventilated patients with ARDS was still as high as approximately 40 1 which implies that better management strategies for them are needed to improve the outcomes
In the management for the mechanical ventilated patients with ARDS the timing and judgement for extubation is clinically important because extubation failure can be associated with worse outcome 2 The most recent ARDS guidelines recommend a weaning protocol for extubation and introduced several predictive clinical factors for extubation failure but they are mainly based on the studies for patients with acute respiratory failure 3 and there is no study focusing on the patients with ARDS Considering that the best method to extubate successfully has not been determined the clinical management at the timing of extubation can be varied by each institution or each country and the investigators thought that international survey focusing on the management for extubation of ARDS patients would be needed
12 Significance of the study
Our international survey can identify the management associated with better outcome as well as clinical factors to predict extubation failure at the timing of extubation attempt This study will contribute to the development of better management for extubation and thereby improve the outcomes of patients with ARDS
This study has the potential to increase the generalizability of the results which will be obtained from all regions of the world including Asia Europe North and South America Oceania and Africa Therefore the results will potentially contribute to improving patient outcomes in all regions of the world Furthermore the results obtained will provide a detailed picture of the current ICU management given to mechanical ventilated patients with ARDS in the ICU
13Study Design
This study is international multicenter prospective survey
2 Aim of the study and evaluation items 21 Study Hypothesis
Mortality of ARDS patients with extubation failure is higher than those without failure
Management and timing for ventilator weaning and extubation failure is different by each institution each country or each continent some of which is associated with their outcome
Some clinical factors for predicting extubation failure is identified
22 Aim of the study Aim 1 Describing epidemiology management timing and outcome for ventilator weaning and extubation of ARDS patients in the world Aim 2 Comparing the protocol for weaning and extubation between the ARDS patients who had successful extubation and those who did not Aim 3 Comparing the change of respiratory mechanics in the SBT and post-extubation between the ARDS patients who had successful extubation and those who did not Aim 4 Identifying clinical factor available during SBT and in the early times after extubation for predicting extubation failure
Acute respiratory distress syndrome ARDS is a life-threatening condition characterized by widespread inflammatory lung injury and is encountered in an estimated 23 of mechanically ventilated patients 1 Recent studies reported that the mortality of mechanically ventilated patients with ARDS was still as high as approximately 40 1 which implies that better management strategies for them are needed to improve the outcomes
In the management for the mechanical ventilated patients with ARDS the timing and judgement for extubation is clinically important because extubation failure can be associated with worse outcome 2 The most recent ARDS guidelines recommend a weaning protocol for extubation and introduced several predictive clinical factors for extubation failure but they are mainly based on the studies for patients with acute respiratory failure 3 and there is no study focusing on the patients with ARDS Considering that the best method to extubate successfully has not been determined the clinical management at the timing of extubation can be varied by each institution or each country and the investigators thought that international survey focusing on the management for extubation of ARDS patients would be needed
12 Significance of the study
Our international survey can identify the management associated with better outcome as well as clinical factors to predict extubation failure at the timing of extubation attempt This study will contribute to the development of better management for extubation and thereby improve the outcomes of patients with ARDS
This study has the potential to increase the generalizability of the results which will be obtained from all regions of the world including Asia Europe North and South America Oceania and Africa Therefore the results will potentially contribute to improving patient outcomes in all regions of the world Furthermore the results obtained will provide a detailed picture of the current ICU management given to mechanical ventilated patients with ARDS in the ICU
13Study Design
This study is international multicenter prospective survey
2 Aim of the study and evaluation items 21 Study Hypothesis
Mortality of ARDS patients with extubation failure is higher than those without failure
Management and timing for ventilator weaning and extubation failure is different by each institution each country or each continent some of which is associated with their outcome
Some clinical factors for predicting extubation failure is identified
22 Aim of the study Aim 1 Describing epidemiology management timing and outcome for ventilator weaning and extubation of ARDS patients in the world Aim 2 Comparing the protocol for weaning and extubation between the ARDS patients who had successful extubation and those who did not Aim 3 Comparing the change of respiratory mechanics in the SBT and post-extubation between the ARDS patients who had successful extubation and those who did not Aim 4 Identifying clinical factor available during SBT and in the early times after extubation for predicting extubation failure
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