Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446544
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-02-26
Brief Title:
Functional Residual Capacity and Alveolar Recruitment in Single-lung Ventilation a Randomized Study
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Functional Residual Capacity and Alveolar Recruitment in Single-lung Ventilation a Randomized Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
OLVEELV
Brief Summary:
In thoracic surgery the incidence of postoperative pulmonary complications is higher than for other surgeries Indeed thoracic surgery has the specificity of being carried out with single-lung ventilation and is thus a source of intraoperative atelectasis which persists postoperatively and gives rise to pulmonary complications particularly infectious ones During one-lung ventilation mediastinal and abdominal compression on the ventilated lung leads to a drop in functional residual capacity FRC which will in turn lead to collapse of the small airways leading to the formation of atelectasis
Strategies exist to limit the appearance of atelectasis One of the intraoperative strategies is alveolar recruitment Alveolar recruitment is a dynamic process that can be defined by a transient increase in transpulmonary pressure beyond the critical opening pressure Physiologically alveolar recruitment corresponds to the re-aeration of poorly or non-aerated lung areas In single-lung ventilation intraoperative alveolar recruitment maneuvers are not performed systematically to prevent the formation of atelectasis
The General Electric Carescape R860 ventilator allows intraoperative monitoring of end-expiratory closing lung volume EFVP which corresponds to the CRF associated with positive expiratory pressure PEEP This spirometry incorporated in the ventilator continuously monitors the intraoperative variation of VPFE thus making it possible to detect any significant decrease which would favor the formation of intraoperative atelectasis Early detection of VPFE can therefore allow the anesthetist-resuscitator to initiate intraoperative alveolar recruitment maneuvers adapted to the patient Alveolar recruitment maneuvers are then personalized and based on precise monitoring of the evolution of the VPFE
The effectiveness of recruitment maneuvers can be evaluated and quantified with the Lung Ultrasound Score LUS postoperatively using pleuropulmonary ultrasound Thus early ultrasound detection from the post-interventional monitoring room SSPI would make it possible to undertake rapid therapeutic maneuvers to combat the atelectasis observed A patient could benefit for example from prophylactic NIV from the recovery room from a stricter postural program in a seated position or from an earlier andor more intensive respiratory rehabilitation program with the physiotherapy team
Strategies exist to limit the appearance of atelectasis One of the intraoperative strategies is alveolar recruitment Alveolar recruitment is a dynamic process that can be defined by a transient increase in transpulmonary pressure beyond the critical opening pressure Physiologically alveolar recruitment corresponds to the re-aeration of poorly or non-aerated lung areas In single-lung ventilation intraoperative alveolar recruitment maneuvers are not performed systematically to prevent the formation of atelectasis
The General Electric Carescape R860 ventilator allows intraoperative monitoring of end-expiratory closing lung volume EFVP which corresponds to the CRF associated with positive expiratory pressure PEEP This spirometry incorporated in the ventilator continuously monitors the intraoperative variation of VPFE thus making it possible to detect any significant decrease which would favor the formation of intraoperative atelectasis Early detection of VPFE can therefore allow the anesthetist-resuscitator to initiate intraoperative alveolar recruitment maneuvers adapted to the patient Alveolar recruitment maneuvers are then personalized and based on precise monitoring of the evolution of the VPFE
The effectiveness of recruitment maneuvers can be evaluated and quantified with the Lung Ultrasound Score LUS postoperatively using pleuropulmonary ultrasound Thus early ultrasound detection from the post-interventional monitoring room SSPI would make it possible to undertake rapid therapeutic maneuvers to combat the atelectasis observed A patient could benefit for example from prophylactic NIV from the recovery room from a stricter postural program in a seated position or from an earlier andor more intensive respiratory rehabilitation program with the physiotherapy team
Detailed Description:
In thoracic surgery the incidence of postoperative pulmonary complications is higher than for other surgeries Indeed thoracic surgery has the specificity of being carried out with single-lung ventilation and is thus a source of intraoperative atelectasis which persists postoperatively and gives rise to pulmonary complications particularly infectious ones During one-lung ventilation mediastinal and abdominal compression on the ventilated lung leads to a drop in functional residual capacity FRC which will in turn lead to collapse of the small airways leading to the formation of atelectasis
Strategies exist to limit the appearance of atelectasis One of the intraoperative strategies is alveolar recruitment Alveolar recruitment is a dynamic process that can be defined by a transient increase in transpulmonary pressure beyond the critical opening pressure Physiologically alveolar recruitment corresponds to the re-aeration of poorly or non-aerated lung areas In single-lung ventilation intraoperative alveolar recruitment maneuvers are not performed systematically to prevent the formation of atelectasis
The General Electric Carescape R860 ventilator allows intraoperative monitoring of end-expiratory closing lung volume EFVP which corresponds to the CRF associated with positive expiratory pressure PEEP This spirometry incorporated in the ventilator continuously monitors the intraoperative variation of VPFE thus making it possible to detect any significant decrease which would favor the formation of intraoperative atelectasis Early detection of VPFE can therefore allow the anesthetist-resuscitator to initiate intraoperative alveolar recruitment maneuvers adapted to the patient Alveolar recruitment maneuvers are then personalized and based on precise monitoring of the evolution of the VPFE
The effectiveness of recruitment maneuvers can be evaluated and quantified with the Lung Ultrasound Score LUS postoperatively using pleuropulmonary ultrasound Thus early ultrasound detection from the post-interventional monitoring room SSPI would make it possible to undertake rapid therapeutic maneuvers to combat the atelectasis observed A patient could benefit for example from prophylactic NIV from the recovery room from a stricter postural program in a seated position or from an earlier andor more intensive respiratory rehabilitation program with the physiotherapy team
Strategies exist to limit the appearance of atelectasis One of the intraoperative strategies is alveolar recruitment Alveolar recruitment is a dynamic process that can be defined by a transient increase in transpulmonary pressure beyond the critical opening pressure Physiologically alveolar recruitment corresponds to the re-aeration of poorly or non-aerated lung areas In single-lung ventilation intraoperative alveolar recruitment maneuvers are not performed systematically to prevent the formation of atelectasis
The General Electric Carescape R860 ventilator allows intraoperative monitoring of end-expiratory closing lung volume EFVP which corresponds to the CRF associated with positive expiratory pressure PEEP This spirometry incorporated in the ventilator continuously monitors the intraoperative variation of VPFE thus making it possible to detect any significant decrease which would favor the formation of intraoperative atelectasis Early detection of VPFE can therefore allow the anesthetist-resuscitator to initiate intraoperative alveolar recruitment maneuvers adapted to the patient Alveolar recruitment maneuvers are then personalized and based on precise monitoring of the evolution of the VPFE
The effectiveness of recruitment maneuvers can be evaluated and quantified with the Lung Ultrasound Score LUS postoperatively using pleuropulmonary ultrasound Thus early ultrasound detection from the post-interventional monitoring room SSPI would make it possible to undertake rapid therapeutic maneuvers to combat the atelectasis observed A patient could benefit for example from prophylactic NIV from the recovery room from a stricter postural program in a seated position or from an earlier andor more intensive respiratory rehabilitation program with the physiotherapy team
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