Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04607551
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2020-09-28
Brief Title:
PRONing to Facilitate Weaning From ECMO in Patients With Refractory Acute Respiratory Distress Syndrome
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
PRONing to Facilitate Weaning From ECMO in Patients With Refractory Acute Respiratory Distress Syndrome
Status:
COMPLETED
Status Verified Date:
2022-06
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:
PRONECMO
Brief Summary:
ECMO has emerged as a promising intervention that may provide more efficacious supportive care to patients with refractory severe acute respiratory distress syndrome ARDS The largest randomized trial of ECMO for severe forms of ARDS was recently published and demonstrated no significant benefit from early initiation of ECMO with respect to 60-day mortality when compared with a strategy of conventional mechanical ventilation MV ref EOLIA However a rescue ECMO option was used by 28 of the controls which is likely to have diluted the potential positive effect of ECMO One may argue that a less restrictive primary endpoint such as death or rescue ECMO would have yielded positive findings
Meanwhile improvements in technology have made ECMO safer and easier to use allowing for the potential of more widespread application in patients with ARDS VV-ECMO can be used as a life-saving rescue therapy in patients with ARDS when MV cannot maintain adequate oxygenation or CO2 elimination Alternatively VV-ECMO may be used in patients who remain hypoxemic during MV ie PaO2FiO280 mmHg despite optimization of MV including the application of high levels of positive end-expiratory pressure PEEP neuromuscular blockers and prone positioning and allow lung rest by lowering airway pressures and tidal volume to ameliorate ventilator-induced lung injury VILI
Prone positioning PP has been used for more than 30 years in patients with acute hypoxemic respiratory failure and in particular with ARDS Initially PP in ARDS patients was proposed as an efficient mean to improve oxygenation sometimes dramatically in a large number of patients In addition it is now clear and data are still accumulating that PP is also able to prevent VILI which is as important as maintaining safe gas exchange in mechanical ventilation Therefore PP is a strategy that covers the two major goals of ventilator support in ARDS patients maintaining safe oxygenation and preventing VILI and reducing mortality at the end This latter objective makes sense on ECMO as one of the main objective of this device is to markedly reduce VILI by resting the lung
Considering that PP is a valuable and safe therapy to reduce VILI its combination with ECMO could enhance VILI prevention In recent preliminary studies it was reported that the combination of VV-ECMO and PP was associated with a dramatic improvement in oxygenation in pulmonary and thoracic compliance and in chest X-ray findings It may thus facilitate the weaning of ECMO and can be performed without compromising the safety of the patients Lung recruitment and improvement in ventilationperfusion mismatch on prone position may both contribute to improve oxygenation PP may therefore be efficient to hasten the weaning of VV-ECMO when atelectasis and ventilationperfusion mismatch occur under ultra-protective ventilation even in patients in whom pre-ECMO PP failed In addition it could also enhance ventilator induced lung injury prevention on ECMO
Meanwhile improvements in technology have made ECMO safer and easier to use allowing for the potential of more widespread application in patients with ARDS VV-ECMO can be used as a life-saving rescue therapy in patients with ARDS when MV cannot maintain adequate oxygenation or CO2 elimination Alternatively VV-ECMO may be used in patients who remain hypoxemic during MV ie PaO2FiO280 mmHg despite optimization of MV including the application of high levels of positive end-expiratory pressure PEEP neuromuscular blockers and prone positioning and allow lung rest by lowering airway pressures and tidal volume to ameliorate ventilator-induced lung injury VILI
Prone positioning PP has been used for more than 30 years in patients with acute hypoxemic respiratory failure and in particular with ARDS Initially PP in ARDS patients was proposed as an efficient mean to improve oxygenation sometimes dramatically in a large number of patients In addition it is now clear and data are still accumulating that PP is also able to prevent VILI which is as important as maintaining safe gas exchange in mechanical ventilation Therefore PP is a strategy that covers the two major goals of ventilator support in ARDS patients maintaining safe oxygenation and preventing VILI and reducing mortality at the end This latter objective makes sense on ECMO as one of the main objective of this device is to markedly reduce VILI by resting the lung
Considering that PP is a valuable and safe therapy to reduce VILI its combination with ECMO could enhance VILI prevention In recent preliminary studies it was reported that the combination of VV-ECMO and PP was associated with a dramatic improvement in oxygenation in pulmonary and thoracic compliance and in chest X-ray findings It may thus facilitate the weaning of ECMO and can be performed without compromising the safety of the patients Lung recruitment and improvement in ventilationperfusion mismatch on prone position may both contribute to improve oxygenation PP may therefore be efficient to hasten the weaning of VV-ECMO when atelectasis and ventilationperfusion mismatch occur under ultra-protective ventilation even in patients in whom pre-ECMO PP failed In addition it could also enhance ventilator induced lung injury prevention on ECMO
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A02669-48 | OTHER | IDRCB | None |