Clinical trial NCT06133777: Respiratory Variability and Postoperative Complications During Thoracic Lung Resection.
Official title: Description of Respiratory Variability and Postoperative Complications During Thoracic Lung Resection - Exploratory Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Injury
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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

Detailed 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

Eligibility criteria: Inclusion Criteria:

* Patient, man or woman, who signed informed consent
* Patient older than 18 years old
* Patient admitted for planned thoracic resection surgery (lobectomy, bi-lobectomy, pneumonectomy) whatever the etiology is

Exclusion Criteria:

- None (medical aspects)

Primary outcomes:
measure: Coefficient of variation
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital privé de Clairval
name: Kais BEN HASSEN, MD
role: PRINCIPAL_INVESTIGATOR
References: