Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06446544 |
| Other study ID # |
2021/0383/HP |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2024 |
| Est. completion date |
March 1, 2026 |
Study information
| Verified date |
February 2024 |
| Source |
University Hospital, Rouen |
| Contact |
David Mallet |
| Phone |
02 32 88 82 65 |
| Email |
nell.marty[@]chu-rouen.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 and/or more intensive
respiratory rehabilitation program with the physiotherapy team.
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 and/or more intensive
respiratory rehabilitation program with the physiotherapy team.
