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Clinical Trials/NCT06133777
NCT06133777
Not yet recruiting
Not Applicable

Description of Respiratory Variability and Postoperative Complications During Thoracic Lung Resection - Exploratory Study.

GCS Ramsay Santé pour l'Enseignement et la Recherche0 sites60 target enrollmentJuly 1, 2024
ConditionsLung Injury

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Injury
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Enrollment
60
Primary Endpoint
Coefficient of variation
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
October 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Coefficient of variation

Time Frame: Day 1

Each respiratory cycle is defined by an inspiratory time followed by an expiratory time. Ordinary, it is observed a variability compared to the previous cycle in terms of amplitude and temporality. Coefficient of variation is one of the parameters able to measure this respiratory variability.

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