- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04793802
Impact of Physiotherapy Session in Cardiac Surgery Patients
Impact of Physiotherapy Session With or Without Non Invasive Ventilation in the Patient Benefiting From High Nasal Flow Oxygenation After Cardiac Surgery: a Pilot Study
This work consists, first of all, in making an inventory of the physiotherapy of the patient undergoing cardiac surgery under high flow oxygenation at the CHRU NANCY.
Then, in a second step, the impact of the physiotherapy on the lung ultrasound score associated or not with the NIV of the patient under OHD after cardiac surgery will be studied.
The objective is therefore to answer the following research question: what is the impact of a physiotherapy session with or without non-invasive ventilation in patients receiving high flow oxygenation after cardiac surgery on the lung ultrasound score measured by ultrasound?
Main hypothesis: Physiotherapy is associated with NIV when it is prescribed in patients undergoing high flow oxygenation after cardiac surgery.
Secondary hypothesis: Physiotherapy + NIV further improves pulmonary aeration versus physiotherapy + high flow oxygenation.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Nancy, Francia, 54000
- CHRU Nancy
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Person who has received full information on the organization of the research and has not objected to the use of the data.
- Person benefiting from cardiac surgery programmed on Cardiothoracic Bypass
- Patient under high flow oxygenation
- Age ≥ 18 years old
- 18.5 ≤ BMI ≤ 35 kg/m2
- Conscious and oriented patients: Glasgow 15
Exclusion Criteria:
- Surgical emergencies: grafting, dissections...
- Lumbar drainage in progress
- Beating heart surgery
- Refusal to participate in the study
- Persons referred to in Articles L.1121-8 and L.1122-1-2 of the Public Health Code (minors, person under guardianship, under curatorship)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Patients benefiting from HIGH-FLOW OXYGENATION + NONINVASIVE VENTILATION
Patients benefiting from high-flow oxygenation will have their physiotherapy session with non-invasive ventilation.
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session of physiotherapy
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Patients benefiting from HIGH-FLOW OXYGENATION
Patients benefiting from high-flow oxygenation will have their physiotherapy session without non-invasive ventilation.
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session of physiotherapy
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Lung ultrasound score
Lasso di tempo: The time of the event (the 2 measurements + the physiotherapy session) is estimated at 45 minutes.
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Reliable and verified score, subject to international recommendations allowing the physiotherapist to deepen his diagnosis and evaluate the effectiveness of his techniques. Measured on 12 thoracic regions The score (N B1 B2 C) will therefore be calculated according to the level obtained in each zone to determine a score out of 36. The higher the score, the more the lung has a deficit of ventilation. A decrease in the objective lung ultrasound score will result in better lung aeration. Two lung ultrasound score measurements are realized on one patient. The first measurement is taken on the day of inclusion of the patient in the study at the time of the physiotherapist's assessment before the CPT session. (CPT = Chest Physiotherapy Treatment) The second and last measurement is taken after the CPT session (with or without NIV, depending on the medical prescription). |
The time of the event (the 2 measurements + the physiotherapy session) is estimated at 45 minutes.
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Jean PAYSANT, MD PhD, Central Hospital, Nancy, France
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2020PI208
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