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NCT Number: NCT05470686

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

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

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Key information

Conditions

Heart Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Person having received complete information on the organization of the research and having given written consent to participate
  • Person having benefited from a heart surgery under cardio-pulmonary bypass
  • Medical prescriptions for non invasive ventilation and physiotherapist
  • Age ≥ 18 years
  • 18.5 ≤ BMI ≤ 35 kg/m2
  • Visual Analogy Scale pain < 4
  • Patient conscious and oriented: Glasgow 15/15

Exclusion criteria

  • At the patient's request : a patient may withdraw from the research at any time without affecting the quality of care to which he or she is entitled (withdrawal of consent).
  • Cardiorespiratory arrest during the inclusion visit.
  • Need for orotracheal reintubation during the inclusion visit.
  • Patient non-cooperation during the inclusion visit.
  • Failure of the ultrasound machine during the inclusion visit.
  • Failure of the blood gas analyzer.
  • Glasgow < 15 during the inclusion visit
  • PEEP > 6 cmH2O required during physiotherapy + non invasive ventilation session
  • PEEP < 6 cmH2O required during physiotherapy + non invasive ventilation session
  • Premature interruption of the physiotherapy session + non invasive ventilation not hemodynamically tolerated
  • Need for a session of non invasive ventilation + physiotherapy > 30 minutes.

Treatment and study plan

blood gas via arterial catheter

Biological

Patients will have a blood sample plus a lung ultrasound before and after the physical therapy session combined with non invasive ventilation the morning after the heart surgery

Other names: Lung ultrasound score

Primary outcomes

  1. Relative difference in PaO2/FiO2 ratio: (measurement after - measurement before the physiotherapy session + non invasive ventilation) / measurement before.)

    Time frame: the morning after the heart surgery

    The higher the ratio, better is the result. Between approximately 0 and 400

  2. Difference in lung ultrasound score: measurement after - measurement before the physiotherapy session + non invasive ventilation

    Time frame: the morning after the heart surgery

    Lung ultrasound score = global measurement on 12 thoracic regions (6 per hemithorax: 2 anteriors, 2 laterals, 2 posteriors) to obtain a result out of 36 (sum of all values found in each zone). Each zone is evaluated as follows:

    0 = normal ventilation

    • = multiple B-lines defined
    • = coalescing B-lines
    • = pulmonary consolidation

Secondary outcomes

  1. Lung ultrasound score values obtained by both evaluators from the same recorded ultrasound images. If there is a difference of one point between the two scores measured, a third reading by a doctor will be taken. This 3rd score will then be retained.

    Time frame: in the week following the measurements

    If there is a difference of one point between the two scores measured, a third reading by a doctor will be taken. This 3rd score will then be retained.

  2. relative difference in PaO2/FiO2 ratio

    Time frame: the morning after the heart surgery

    The higher the ratio, better is the result. Between approximately 0 and 400

  3. difference in lung ultrasound score for each study area

    Time frame: the morning after the heart surgery

    Each zone is rated from 0 to 3 points. The lower the score, the better the result. We look to see if the score for each zone decreases between before and after the physiotherapy session.

  4. initial lung ultrasound score

    Time frame: the morning after the heart surgery

    Lung ultrasound score = global measurement on 12 thoracic regions (6 per hemithorax: 2 anteriors, 2 laterals, 2 posteriors) to obtain a result out of 36 (sum of all values found in each zone). Each zone is evaluated as follows:

    0 = normal ventilation

    • = multiple B-lines defined
    • = coalescing B-lines
    • = pulmonary consolidation

  5. relative difference in PaCO2

    Time frame: the morning after the heart surgery and after physiotherapy session

    The lower the score, the better the result. Ap proximately between 0 and 100

  6. For each subject, answers to two questions at the end of the session about his or her understanding of PAS after the information provided by the MK during the session

    Time frame: the morning after the heart surgery

    Questions asked by the physiotherapist for the patient (at the end of the session) :

    • Did you understand the explanations provided by the physiotherapist regarding the lung ultrasound results? Yes, completely Yes, partially No No answer
    • Did the explanations provided by the physiotherapist regarding the results of the lung ultrasound score help you understand the movements or displacements that the physiotherapist asked you to make during this session? Yes, completely Yes, partially No No answer

    Translated with www.DeepL.com/Translator (free version)

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie roth oudin

CONTACT

[email protected]

03 83 15 41 96

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Study of the Relationship Between the Relative Variation of PaO2/FiO2 and the Variation of Lung Ultrasound Score During the First Session of Physiotherapy Associated With Non-invasive Ventilation in Cardiac Surgery Patients by Cardiopulmonary Bypass

Acronym: PaFiKinESAP

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 22, 2022
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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