Respiratory Variability and Postoperative Complications During Thoracic Lung Resection. (RESPIVARIA)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Injury
• Intervention / Treatment: Other: Respiratory variability monitoring

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kais BEN HASSEN, MD; Phone Number: +33491171421; Email: kais.benhassen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coefficient of variation	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.	Day 1

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Kais BEN HASSEN, MD, Hôpital privé de Clairval

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Postoperative Complications; Lung Injury
• Other Study ID Numbers: 2023-A00931-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No