Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06133777 |
| Other study ID # |
2023-A00931-44 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
October 30, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
GCS Ramsay Santé pour l'Enseignement et la Recherche |
| Contact |
Kais BEN HASSEN, MD |
| Phone |
+33491171421 |
| Email |
kais.benhassen[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Postoperative respiratory complications (PRC) represent a major public health issue. Majority
of PRCs occur once the patient leaves the post-interventional monitoring room.
Identifying patients at risk for PRC is therefore an important step for improving their
post-operative care. In this context, any clinical marker making it possible to detect early
alteration of the respiratory state in the postoperative phase deserves to be evaluated.
This study is based on the hypothesis that measuring indices of respiratory variability which
is synonymous with "good respiratory health" can be part of these markers.
The measurement of respiratory variability will be done in patients with thoracic lung
resection surgery before anesthetic induction and in the postoperative phase after
extubation. It will be measured using a belt equipped with an external sensor allowing
automatic and continuous analysis of thoracic movement by frequency analysis
Description:
Postoperative respiratory complications (PRC) represent a major public health issue. By PRC,
we mean acute respiratory distress, bronchospasm, pleural effusion, respiratory infection,
atelectasis, aspiration pneumonia and pneumothorax.
Postoperative respiratory dysfunction reaches its peak in the 48 hours following surgery.
Majority of PRCs therefore occur once the patient leaves the post-interventional monitoring
room.
Identifying patients at risk for PRC is an important step for improving their post-operative
care. For this, there are predictive scores, notably the ARISCAT score, pre-operatively.
However, there are few measurement methods to detect early alteration of the respiratory
state in the postoperative phase. Therefore, the physician in charge of the patient is
alerted late if the patient deteriorates on the respiratory plan.
In this context, any clinical marker making it possible to detect early alteration of the
respiratory state in the postoperative phase deserves to be evaluated. Therefore, this study
is based on the hypothesis that measuring indices of respiratory variability can be part of
these markers. Consequently, this research which aims to describe these indices of
respiratory variability is of major interest.
Respiratory variability is synonymous with "good respiratory health". By the opposite, the
reduction of this same variability is pathological and indicates an increase in the level of
load imposed on the respiratory system.
The measurement of respiratory variability will be done in patients with thoracic lung
resection surgery before anesthetic induction and in the postoperative phase after
extubation. It will be measured using a belt equipped with an external sensor allowing
automatic and continuous analysis of thoracic movement by frequency analysis
