Mängden kvävgasbubblor i Blodet Efter Dykning Vid Syrgasandning jämfört Med Luftandning
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Venous gas emboli
研究概览
简要总结
Primary objective:
- Assessment of venous gas emboli load post diving when breathing normobaric oxygen compared to air.
Secondary objective:
- Assessment of fluid markers of central nervous system injury in blood post diving
- Assessment of fluid markers of inflammation and endothelial dysfunction in blood post diving
Tertiary objective:
- Assessment of DCS frequency
详细描述
This is a prospective, double blinded, randomized, cross-over study in Sweden. The study was performed in two different sets, each containing standardized dives in a wet hyperbaric chamber. The dives included movement on depth.
In each study set 16-32 professional divers performed no-decompression dives to a depth of 42 metres of seawater (msw). The gas used during the dives was compressed air.
After surfacing the divers breathed either normobaric oxygen or normobaric air on a demand mask. Timing of oxygen/air-breathing differed between study sets. The content of breathing gas was unknown to both divers and examining personnel.
Immediately post dive the divers were assessed using either transthoracic doppler ultrasound (TTD) or transthoracic 2-D ultrasound (TTE) to determine VGE load, time to VGE detection and VGE duration.
Signs of DCS were actively sought.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Professional diver
- •Fit to dive according to Swedish Navy standards
排除标准
- 未提供
研究组 & 干预措施
Air
Normobaric air breathing
干预措施: Air (Other)
Oxygen
Normobaric oxygen breathing
干预措施: Oxygen (Drug)
结局指标
主要结局
Venous gas emboli
时间窗: 120 minutes
Kisman-Masurel grading
次要结局
- Inflammatory activity and endothelial dysfunction(120 minutes/ 48 hours)
- Decompression sickness(24 hours)
- Markers of central nervous system injury(120 minutes/ 48 hours)
研究者
Nicklas Oscarsson
MD
Göteborg University