- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Nancy, Frankrike, 54000
- CHRU Nancy
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Patients benefiting from HIGH-FLOW OXYGENATION + NONINVASIVE VENTILATION
Patients benefiting from high-flow oxygenation will have their physiotherapy session with non-invasive ventilation.
|
session of physiotherapy
|
Patients benefiting from HIGH-FLOW OXYGENATION
Patients benefiting from high-flow oxygenation will have their physiotherapy session without non-invasive ventilation.
|
session of physiotherapy
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Lung ultrasound score
Tidsramme: The time of the event (the 2 measurements + the physiotherapy session) is estimated at 45 minutes.
|
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.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Jean PAYSANT, MD PhD, Central Hospital, Nancy, France
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2020PI208
Legemiddel- og utstyrsinformasjon, studiedokumenter
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