RESPIVARIA: Respiratory Variability and Postoperative Complications During Thoracic Lung Resection.

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06133777
Collaborator
(none)
60
1
19

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Respiratory variability monitoring
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Description of Respiratory Variability and Postoperative Complications During Thoracic Lung Resection - Exploratory Study.
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Respiratory Variability Monitoring

Respiratory variability will be measured using a belt equipped with an external sensor allowing automatic and continuous analysis of thoracic movement by frequency analysis

Other: Respiratory variability monitoring
Respiratory variability will be measured using a belt equipped with an external sensor allowing automatic and continuous analysis of thoracic movement by frequency analysis

Outcome Measures

Primary Outcome Measures

  1. Coefficient of variation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

  • Principal Investigator: Kais BEN HASSEN, MD, Hôpital privé de Clairval

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GCS Ramsay Santé pour l'Enseignement et la Recherche
ClinicalTrials.gov Identifier:
NCT06133777
Other Study ID Numbers:
  • 2023-A00931-44
First Posted:
Nov 15, 2023
Last Update Posted:
Nov 15, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2023