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.

Study Overview

• Status: Completed
• Conditions: Physical Therapy in Cardiac Surgery Patients
• Intervention / Treatment: Other: PHYSIO

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • CHRU Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The subjects of the study will be patients who stayed in the Cardiovascular Surgery and Cardiac Transplant Intensive Care Unit at NANCY CHRU from September 15, 2020 to March 15, 2021

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients benefiting from HIGH-FLOW OXYGENATION + NONINVASIVE VENTILATION; Patients benefiting from high-flow oxygenation will have their physiotherapy session with non-invasive ventilation.	Other: PHYSIO; session of physiotherapy
Patients benefiting from HIGH-FLOW OXYGENATION; Patients benefiting from high-flow oxygenation will have their physiotherapy session without non-invasive ventilation.	Other: PHYSIO; session of physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung ultrasound score	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.

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Jean PAYSANT, MD PhD, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): March 15, 2021

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Physiotherapy; Cardiac surgery; Noninvasive ventilation; Lung ultrasound score; High flow oxygenation
• Other Study ID Numbers: 2020PI208

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No