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Impact of Physiotherapy Session in Cardiac Surgery Patients

2022年5月11日 更新者:PAYSANT Jean、Central Hospital, Nancy, France

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.

研究概览

研究类型

观察性的

注册 (实际的)

33

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Nancy、法国、54000
        • CHRU Nancy

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

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)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Lung ultrasound score
大体时间: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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jean PAYSANT, MD PhD、Central Hospital, Nancy, France

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年9月15日

初级完成 (实际的)

2020年9月15日

研究完成 (实际的)

2021年3月15日

研究注册日期

首次提交

2020年12月4日

首先提交符合 QC 标准的

2021年3月9日

首次发布 (实际的)

2021年3月11日

研究记录更新

最后更新发布 (实际的)

2022年5月13日

上次提交的符合 QC 标准的更新

2022年5月11日

最后验证

2022年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2020PI208

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