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临床试验/NCT04344106
NCT04344106Unknown不适用

Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study (ProCov)

ELHARRAR Xavier2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
25
试验地点
2
主要终点
Proportion of "responder" patients to prone position

研究概览

简要总结

The prone position consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day and could help spontaneous ventilate the patient.

详细描述

SARS-CoV-2 is an RNA virus whose tropism for the respiratory system is responsible for many cases of acute respiratory failure. This can lead to acute respiratory distress syndrome (ARDS) requiring orotracheal intubation and mechanical ventilation. The prone position is a validated intensive care technique in the treatment of ARDS in mechanically ventilated patients. Performing prone position sessions improves patient oxygenation by optimizing the ventilation/perfusion ratios of the posterior areas of the lungs.

There is limited data in the literature on the ventral decubitus in spontaneous ventilation. They are mainly case series or retrospective studies. In the case of the SARS-CoV-2 epidemic, we are seeing patients with posterior lung involvement who may benefit from prone position sessions prior to mechanical ventilation. This maneuver, usually done in an intubated-ventilated-curarized patient, will be done in our spontaneous ventilation study in a conscious patient.The patient will then be placed in prone position with the help of physiotherapists so that the patient is correctly positioned.

The maneuver and the clinical monitoring of the patient's tolerance to the prone position will be done under medical and paramedical supervision, including monitoring of saturation during and after the procedure. A polygraph will also be installed on the patient in order to monitor the patient's position (on the back vs. on the stomach), saturation and heart rate during the entire prone position session. An arterial gasometry will be performed before the patient is placed in the prone position, one hour after and after returning to the supine position.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged at least 18 years;
  • Hospitalized in a COVID unit or intensive care unit;
  • Spontaneously breathing and with oxygen therapy with nasal canula, mask or High Flow Oxygen Therapy;
  • Requiring oxygen therapy ≥ 1l for Sat ≥ 90%;
  • COVID 19 positive in RT-PCR or diagnosis on clinicals symptoms and highly evocatives scannographics lesions in an epidemic period;
  • Chest scanner without injection within 72 hours prior to inclusion;
  • Bilateral scannographic lesions, including posterior condensations and/or posterior predominance of lesions;
  • Patient benefiting from French social security, under any regime

排除标准

  • acute respiratory distress (polypnea >25 or use of accessory respiratory muscles);
  • Alteration of consciousness;
  • Active or recent hemoptysis (<1 month);
  • Recent Thrombo-Embolic Venous Disease (< 1 month);
  • Pericardial effusion;
  • Pleural effusion of high abundance, clinical or scannographic;
  • Chronic back or cervical pain/ history of spinal surgery/ bone metastases;
  • Wounds, facial trauma, tracheal, sternal or facial surgery < 15 days;
  • Recent abdominal surgery (< 1 month);
  • Intracranial HyperTension > 30mmHg;
  • Patient deprived of liberty, under guardianship or curatorship;
  • Pregnant or lactating woman.

结局指标

主要结局

Proportion of "responder" patients to prone position

时间窗: 1 hour

PaO2 improvement of more than 20% after one hour in prone position in spontaneously breathing non intubated COVID-19 patients.

次要结局

  • proportion of "persistent responders" patients after prone position(1 day)
  • Evolution of PaO2(1 day)
  • Duration of prone positioning and PaO2 evolution(2 days)
  • Evolution of Spo2(1 hour)
  • EVA Dyspnea(1 day)
  • Intolerance to prone positioning(1 day)
  • Tolerance to prone positioning(1 day)

研究者

发起方
ELHARRAR Xavier
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

ELHARRAR Xavier

pulmologist

Centre Hospitalier Intercommunal Aix-Pertuis

研究点 (2)

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