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RecruitingNCT05470686PaFiKinESAPUpdated Aug 21, 2024

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

An interventional study of blood gas via arterial catheter in Heart Surgery, sponsored by Central Hospital, Nancy, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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
02

Conditions studied

  • Heart Surgery

Keywords

  • heart surgery
  • Lung ultrasound score
  • PaO2/FiO2 ration
  • physiotherapy
  • Non invasive ventilation
03

In context

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Other
    HEART SURGERY PATIENTS with cardio pulmonary bypass

    Biological: blood gas via arterial catheter

Interventions

  • Biologicalblood gas via arterial catheter

    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

    Also known as: Lung ultrasound score

06

What researchers measure

Primary outcomes

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

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

    Time frame: the morning after the heart surgery

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

    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 1. = multiple B-lines defined 2. = coalescing B-lines 3. = pulmonary consolidation

    Time frame: the morning after the heart surgery

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.

    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

  2. relative difference in PaO2/FiO2 ratio

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

    Time frame: the morning after the heart surgery

  3. difference in lung ultrasound score for each study area

    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.

    Time frame: the morning after the heart surgery

  4. initial lung ultrasound score

    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 1. = multiple B-lines defined 2. = coalescing B-lines 3. = pulmonary consolidation

    Time frame: the morning after the heart surgery

  5. relative difference in PaCO2

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

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

  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

    Questions asked by the physiotherapist for the patient (at the end of the session) : 1. Did you understand the explanations provided by the physiotherapist regarding the lung ultrasound results? Yes, completely Yes, partially No No answer 2. 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)

    Time frame: the morning after the heart surgery

07

Study locations

1 of 1 sites recruiting
  • centralHNF
    Vandœuvre-lès-Nancy, 54511, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05470686
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Aurelie OUDIN-ROTH (Principal Investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
Jul 22, 2022
Start date
Jun 21, 2023
Primary completion
Dec 2024 (estimated)
Completion
Jul 2025 (estimated)
Last update
Aug 21, 2024

Study contacts

Aurélie roth oudin
Contact
a.roth@chru-nancy.fr
03 83 15 41 96
Jean PAYSANT
study director · Central Hospital, Nancy, France

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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