Impact of Hydrogen Sulfide on Lung Health: Study of Chronic Exposure of the Population Living on the Atlantic Coast and on the Caribbean Coast, in Martinique, During the Stranding Period and Outside the Stranding Period of Sargassum Seaweeds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Compare the expired fractions of nitric oxide between people exposed and not exposed to toxic gases from sargassum in Martinique
研究概览
简要总结
Sargassum are pelagic brown sea algae. Two species grow on the surface of the ocean and drift freely with ocean currents in the form of slicks: the pelagic Sargassum fluitans and Sargassum natans.
Since 2011, massive strandings of Sargassum seaweed in the French West Indies are to be deplored. In recent years, strandings have increased. In Martinique, sargassum stranding occurs mainly on the Atlantic coast. The duration of stranding from one year to another is variable, but the period during which the stranding is maximum is between April and October.
The accumulation of strandings causes the compaction of algae and limits access to oxygen, which leads to anaerobic degradation which quickly results in the release of various gases, in particular hydrogen sulphide (H2S).
Acute H2S poisoning is well characterized clinically according to exposure (cutaneous, respiratory, ophthalmological, digestive, neurological symptoms, etc.). On the other hand, there are very few data available on the clinical effects of prolonged, repeated exposure and most often at low doses.
Among the toxic effects for which there are still uncertainties regarding long-term exposure to H2S are lung function, measured by spirometry, and airway inflammation, appreciable by measurement of FeNO (fractional exhaled nitric oxide).
The investigators consider it relevant to focus on the clinical and biological characteristics of the population exposed to sargassum in Martinique, in the field, assuming that exposure to sargassum H2S causes pulmonary effects measurable by spirometry and by FeNO, during the stranding period and outside this period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Adult participant (age greater than or equal to 18),
- •Participant living on the Atlantic coast in Martinique, close (less than 300 meters) to sargassum seaweed stranding areas (exposed group),
- •Participant living on the Caribbean coast, in Martinique (unexposed group),
- •Participant having been informed of the research,
- •Participant having given his free, informed and express consent,
- •Participant affiliated to a social security scheme.
排除标准
- •Minor Participant,
- •Participant with a known respiratory or cardiac pathology,
- •Participant with a cognitive state that does not allow him to answer the questionnaire,
- •Participant who refused to participate in the study,
- •Pregnant or breastfeeding women.
研究组 & 干预措施
People exposed to sargassum seaweed stranding
Participant living on the Atlantic coast of Martinique island (hit by the strandings), close (less than 300 meters) to sargassum seaweed stranding areas: exposed group (85 subjects).
Participants will be examined directly at their place of residence.
Participants will be examinated two times:
- at Visit 1 - Day 0 during the strandings period,
- at Visit 2 - M+6 months (+/-1 month) after the end of the strandings.
干预措施: FeNO (fractional exhaled nitric oxide) (Procedure)
People exposed to sargassum seaweed stranding
Participant living on the Atlantic coast of Martinique island (hit by the strandings), close (less than 300 meters) to sargassum seaweed stranding areas: exposed group (85 subjects).
Participants will be examined directly at their place of residence.
Participants will be examinated two times:
- at Visit 1 - Day 0 during the strandings period,
- at Visit 2 - M+6 months (+/-1 month) after the end of the strandings.
干预措施: Spirometry (Procedure)
People exposed to sargassum seaweed stranding
Participant living on the Atlantic coast of Martinique island (hit by the strandings), close (less than 300 meters) to sargassum seaweed stranding areas: exposed group (85 subjects).
Participants will be examined directly at their place of residence.
Participants will be examinated two times:
- at Visit 1 - Day 0 during the strandings period,
- at Visit 2 - M+6 months (+/-1 month) after the end of the strandings.
干预措施: Physical examination (Other)
People exposed to sargassum seaweed stranding
Participant living on the Atlantic coast of Martinique island (hit by the strandings), close (less than 300 meters) to sargassum seaweed stranding areas: exposed group (85 subjects).
Participants will be examined directly at their place of residence.
Participants will be examinated two times:
- at Visit 1 - Day 0 during the strandings period,
- at Visit 2 - M+6 months (+/-1 month) after the end of the strandings.
干预措施: Interrogation (Other)
People not exposed to sargassum seaweed stranding
Participant living on the Caribbean coast of Martinique island (not hit by the strandings): unexposed group (85 subjects).
Participants will be examined directly at their place of residence.
Participants will be examinated two times:
- at Visit 1 - Day 0 during the strandings period,
- at Visit 2 - M+6 months (+/-1 month) after the end of the strandings.
干预措施: FeNO (fractional exhaled nitric oxide) (Procedure)
People not exposed to sargassum seaweed stranding
Participant living on the Caribbean coast of Martinique island (not hit by the strandings): unexposed group (85 subjects).
Participants will be examined directly at their place of residence.
Participants will be examinated two times:
- at Visit 1 - Day 0 during the strandings period,
- at Visit 2 - M+6 months (+/-1 month) after the end of the strandings.
干预措施: Spirometry (Procedure)
People not exposed to sargassum seaweed stranding
Participant living on the Caribbean coast of Martinique island (not hit by the strandings): unexposed group (85 subjects).
Participants will be examined directly at their place of residence.
Participants will be examinated two times:
- at Visit 1 - Day 0 during the strandings period,
- at Visit 2 - M+6 months (+/-1 month) after the end of the strandings.
干预措施: Physical examination (Other)
People not exposed to sargassum seaweed stranding
Participant living on the Caribbean coast of Martinique island (not hit by the strandings): unexposed group (85 subjects).
Participants will be examined directly at their place of residence.
Participants will be examinated two times:
- at Visit 1 - Day 0 during the strandings period,
- at Visit 2 - M+6 months (+/-1 month) after the end of the strandings.
干预措施: Interrogation (Other)
结局指标
主要结局
Compare the expired fractions of nitric oxide between people exposed and not exposed to toxic gases from sargassum in Martinique
时间窗: 6 months
The primary endpoint of the study will be FeNO (exhaled fraction of nitric oxide). FeNO measurement is a marker of airway inflammation. This is a test used routinely for the non-invasive detection and quantification of bronchial inflammation. FeNO is considered normal for values of 16-25 ppb. A FeNO value \> 25 ppb will be a reason for consultation at the Martinique Hospital for additional assessment.
次要结局
- Compare the pulmonary effects (spirometric) related to the emission of toxic gases from Sargassum between people exposed and those not exposed to Sargassum in Martinique.(6 months)
- Compare the pulmonary effects (clinical) related to the emission of toxic gases from Sargassum between people exposed and those not exposed to Sargassum in Martinique.(6 month)