Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05470686

Study of the Relationship Between the Oxygenation State and Lung Ultrasound Score in Cardiac Surgery

Led by Central Hospital, Nancy, France · Updated on 2024-08-21

80

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

After conventional cardiac surgery, many respiratory complications are possible. Therefore, the resuscitator prescribe physiotherapy and non invasive ventilation. The physiotherapist has few reliable tools to evaluate and follow the patient on his ventilatory function. Currently, lung ultrasound is little used in physiotherapy and no study explains the link between the lung ultrasound results and oxygenation patient state. Before considering the interest of lung ultrasound score as a criterion of effectiveness of a physiotherapy treatment through future studies, it is first important to objectivize the existence of a relationship between lung ultrasound score and the PaO2/FiO2 ratio after cardiac surgery. Lung ultrasound could provide direct clinical information without having to resort to other more invasive examinations to objectify the improvement of the patient's oxygenation. Main objective To show that the relative change in the PaO2/FiO2 ratio correlates with the change in lung ultrasound score measured in the short term between the beginning and the end of the first physiotherapy session associated with non invasive ventilation the day after surgery in cardiac patients Secondary objectives * To study the inter-operator (2 readers) reproducibility of the lung ultrasound score measurement. * To study the relationship between the relative variation of the PaO2/FiO2 ratio and the variation of each of the 12 zones of the lung ultrasound score * To Study the relationship between the initial lung ultrasound score and the relative variation of the PaO2/FiO2 ratio * To study the relative variation of the PaCO2 and the variation of the lung ultrasound score between the beginning and the end of the first session of physiotherapy management associated with NIV * To obtain from the patient in the short term feedback on his or her understanding of the explanations about lung ultrasound score provided by the physiotherapist during the session

CONDITIONS

Official Title

Study of the Relationship Between the Oxygenation State and Lung Ultrasound Score in Cardiac Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Received complete information about the study and given written consent to participate
  • Have had heart surgery using cardiopulmonary bypass
  • Have medical prescriptions for non-invasive ventilation and physiotherapy
  • Age 18 years or older
  • Body Mass Index (BMI) between 18.5 and 35 kg/m2
  • Pain level less than 4 on the Visual Analogy Scale
  • Fully conscious and oriented with a Glasgow score of 15/15
Not Eligible

You will not qualify if you...

  • Patient chooses to withdraw consent at any time
  • Experienced cardiorespiratory arrest during the inclusion visit
  • Requires orotracheal reintubation during the inclusion visit
  • Shows non-cooperation during the inclusion visit
  • Ultrasound machine failure during the inclusion visit
  • Blood gas analyzer failure
  • Glasgow score less than 15 during the inclusion visit
  • Requires positive end-expiratory pressure (PEEP) greater than 6 cmH2O during physiotherapy and ventilation session
  • Requires PEEP less than 6 cmH2O during physiotherapy and ventilation session
  • Physiotherapy and ventilation session stopped early due to poor hemodynamic tolerance
  • Need for physiotherapy and ventilation sessions longer than 30 minutes

AI-Screening

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Trial Site Locations

Total: 1 location

1

centralHNF

Vandœuvre-lès-Nancy, France, 54511

Actively Recruiting

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Research Team

A

Aurélie roth oudin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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