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Recruiting NCT05470686

NCT05470686 Study of the Relationship Between the Oxygenation State and Lung Ultrasound Score in Cardiac Surgery

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Clinical Trial Summary
NCT ID NCT05470686
Status Recruiting
Phase
Sponsor Central Hospital, Nancy, France
Condition Heart Surgery
Study Type INTERVENTIONAL
Enrollment 80 participants
Start Date 2023-06-21
Primary Completion 2024-12

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
blood gas via arterial catheter

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 80 participants in total. It began in 2023-06-21 with a primary completion date of 2024-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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

Eligibility Criteria

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.

Contact & Investigator

Central Contact

Aurélie roth oudin

✉ a.roth@chru-nancy.fr

📞 03 83 15 41 96

Principal Investigator

Jean PAYSANT

STUDY DIRECTOR

Central Hospital, Nancy, France

Frequently Asked Questions

Who can join the NCT05470686 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05470686 currently recruiting?

Yes, NCT05470686 is actively recruiting participants. Contact the research team at a.roth@chru-nancy.fr for enrollment information.

Where is the NCT05470686 trial being conducted?

This trial is being conducted at Vandœuvre-lès-Nancy, France.

Who is sponsoring the NCT05470686 clinical trial?

NCT05470686 is sponsored by Central Hospital, Nancy, France. The principal investigator is Jean PAYSANT at Central Hospital, Nancy, France. The trial plans to enroll 80 participants.

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