Clinical Trials Logo

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date October 30, 2025
Est. primary completion date October 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05054270 - Efficacy of Lung Ultrasound in Monitoring Fluid Resuscitation in Chest Trauma Patients
Not yet recruiting NCT04470297 - Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19 Phase 2
Not yet recruiting NCT01184313 - Acute Lung Injury After Aortic Valve Surgery N/A
Not yet recruiting NCT06296173 - Open Lung Protective Extubation Following General Anesthesia N/A
Not yet recruiting NCT03661502 - Effect of Variable Volume Ventilation on Lung Compliance N/A
Recruiting NCT04296071 - Neutrophil Phenotypic Profiling and Acute Lung Injury in Patients After Cardiopulmonary Bypass (CPB)
Completed NCT04645316 - The Effect of Sevoflurane and Desflurane on Clara Cell Protein on the Lung N/A
Recruiting NCT02299921 - Effect of Alcohol and Drugs of Abuse on Immune Function in Critically Ill Patients With Respiratory Failure
Recruiting NCT05559970 - Inhalational Sedation and Mechanical Power N/A
Completed NCT03581006 - Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Trial
Recruiting NCT05228717 - Point-of-care Lung Ultrasound (POCUS)-Integrated Study of Admitted Patients With COVID-19
Recruiting NCT04372953 - Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial). N/A
Not yet recruiting NCT05363085 - The Cerebral-Respiratory Interaction in Controlled Mechanically Ventilated Neurosurgical Patients. (The CeRes-CMV Study)
Recruiting NCT02444858 - Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Paraquat Poisoning Induced Lung Injury Phase 1/Phase 2
Completed NCT03924206 - Hazardous Surgical Smoke: Risk Assessment and Evaluation of a New Smoke Extractor System in the Surgical Unit
Withdrawn NCT01939067 - Infant Pulmonary Mechanics: High Flow Nasal Cannula Versus Nasal CPAP Phase 1
Recruiting NCT05401474 - Individualization Flow in Patients Treated With High Flow Nasal Therapy (iFLOW) N/A
Completed NCT03437499 - Adrenomedullin Changes After Sustained Inflation or Positive Pressure Ventilation at Birth N/A
Not yet recruiting NCT05381415 - Effect on Bronchodilation Response and Ventilation Heterogeneity of Different Inhalation Volumes in COPD
Recruiting NCT04989439 - Comparison of Computertomography Scan, Electrical Impedance Tomography, and Ultrasound of the Lung in Infants