跳至主要内容
临床试验/NCT05049889
NCT05049889招募中不适用

Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema

Direction Centrale du Service de Santé des Armées4 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2022年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
63
试验地点
4
主要终点
Hemodynamic modifications of the cardiac cavities after exercise

研究概览

简要总结

Immersion Pulmonary Edema (IPE) is a relatively new form of hemodynamic pulmonary edema. The number of cases has been increasing over the last ten years and it has become the second most common cause of hospitalization for military divers, after decompression sickness. The pathophysiological mechanisms of IPE are not completely known. Its occurrence is linked to a combination of factors related to the environmental constraints of diving, as well as to the diver's equipment. The main external factors are increased hydrostatic pressure, cold, intense effort and emotional stress. The impact of internal factors is not known. At this time, no severe forms of IPE have been identified in the military. However, it is important to identify this pathology at an early stage, even if the signs appear minor, because the continuation of underwater activity can significantly worsen the clinical picture. The risk of recurrence (greater than 15%) could result in a severe or even lethal accident.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

盲法说明

The investigator who will be in charge of the physiological examination will not know the subject's group.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Military or civilian diver with at least 100 dives
  • Between the ages of 18 and 60
  • Good physical condition (able to run/swim for 30 minutes at a constant pace).

排除标准

  • Divers with a current temporary medical incapacity to dive
  • Persons with contraindications to physical exercise and/or scuba diving
  • Pregnant or breastfeeding women

结局指标

主要结局

Hemodynamic modifications of the cardiac cavities after exercise

时间窗: Until the end of the study (49 months)

The hemodynamic modifications of the cardiac cavities (before/after exercise) will be measured with transthoracic cardiac ultrasound.

Ventilatory regimes

时间窗: Until the end of the study (49 months)

Ventilation regimes will be measured with transthoracic pulmonary ultrasound.

Pulmonary compliance

时间窗: Until the end of the study (49 months)

Ventilation regimes will be measured with transthoracic pulmonary ultrasound.

次要结局

未报告次要终点

研究者

发起方
Direction Centrale du Service de Santé des Armées
申办方类型
Other
责任方
Sponsor

研究点 (4)

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