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临床试验/NCT03354234
NCT03354234已完成不适用

Evaluation of a Prototype System for Generating Conditions of Orthostatic Hypotension and Blood Pooling in the Lower Body

Military Institute of Aviation Medicine1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2017年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
HR

研究概览

简要总结

The pilot study aims to evaluate a prototype system that enables military pilots to train under conditions of orthostatic hypotension and ischemic hypoxia. Both of these phenomena are experienced by aircraft crews of mainly highly maneuverable aircraft, and their syndromes include loss of color vision, loss of peripheral vision, blackout and finally G-induced loss of consciousness (G-LOC). A motorized tilt table to generate orthostatic (ORTHO) stress combined with an automatically controlled lower body negative pressure (LBNP) chamber to extort pooling of blood in the lower extremities has been developed in order to obtain new knowledge on counteracting the above-mentioned effects and minimizing the risk of their occurrence. This will help optimize the selection procedures of candidates with the best physiological predispositions to work as military pilots. The system is equipped with modules for monitoring biomedical parameters of a subject, including cerebral oxygenation, which ensures their safety and provides a source of data for performing advanced analyses. The ORTHO-LBNP system has been subjected to comprehensive laboratory tests and after a successful testing is ready for a pilot study involving pilots and/or cadets of the Polish Air Force Academy (PAFA). It is anticipated that new indicators will be proposed to enable an objective assessment of the predispositions to pursue a military pilot career. The prototype system can be easily adaptable to the needs of clinical and sports medicine as well as rehabilitation.

详细描述

The pilot study consists of two research scenarios, in which two different sequences of the interventions taking the form of the pre-programmed tilt and LBNP profiles are to be investigated.

  1. Scenario I is designed to initially verify the potential impact of the prototype system on the human body. For this purpose, only basic tilt and LBNP stimuli of relatively slowly increasing intensities will be used, and the group of subjects will include only subjects with flight experience. Up to 20 PAFA cadets shortly before graduation, including women and men, will be involved in the pilot study (experimental arm 1). The subjects will be healthy, aged between 20 and 30 years old. Scenario I will take almost 24 min.
  2. Scenario II is to compare subjects with and without flight experience using rapid tilt and LBNP stimuli as well as a push-pull stimulus. Up to 30 subjects including up to 15 pilots, i.e., flight school adepts shortly after graduation and/or PAFA cadets shortly before graduation, and up to 15 students of the Aviation High School in Dęblin, Poland, including women and men will be involved in the study (experimental arm 2). The subjects will be healthy, aged between 18 and 30 years old. The students of the Aviation High School will participate in the study as a reference group, without flight experience. Scenario II will take 16 min.

The pilot study will be carried out in an isolated room in the presence of a physician (physiologist), a paramedic and an ORTHO-LBNP system operator. The paramedic will prepare the subject for the study by placing on his/her body electrodes and measuring sensors that will be removed after completion of the study. The subject will be asked to close his/her eyes during the tests and to place his/her hands on the rest. In order to cause the least disturbance, no conversation will be held with the subject. Only if disturbing symptoms will occur, will the subject immediately report this to the personnel. The physician will systematically be observing the subject's cardiogram, his/her HR, continuous non-invasive arterial pressure (CNAP) wave, and systolic and diastolic blood pressure (SBP and DBP, respectively) in comparison with the changing tilt of the table and negative pressure in the chamber. Any time, at the request of the subject or on the instruction of the physician, the operator will interrupt the tests. The tilt table then will return to the Trendelenburg position if interruption occur during HUT and/or LBNP stimuli, or horizontal position if interruption occur during HDT stimulus. At the same time atmospheric pressure will be resumed in the chamber.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Pilots or cadets with flight experience
  • Candidates for pilots without flight experience
  • None alcohol 24 hours prior to the study
  • Written informed consent

排除标准

  • Subjects with cardiovascular disorders

研究组 & 干预措施

Stimuli of slowly increasing intensities

Experimental
  1. 300-s check before the stimuli
  2. LBNP is applied stepwise with 11.1 mmHg/15 s decrement to -100 mmHg, and then this value is sustained for 120 s
  3. 180-second phase of rest between stimuli
  4. 75°-HUT (5°/s) for 120 s after a 15-s reversing of the gravity vector (-30°)
  5. 180-second phase of rest between stimuli
  6. 75°-HUT (5°/s) accompanied by an exposure to an LBNP of -60 mmHg increased linearly by -4 mmHg/s, and then this value is sustained for 120 s during HUT
  7. 120-s check after the stimuli

干预措施: Head up tilt (HUT) (Other)

Stimuli of slowly increasing intensities

Experimental
  1. 300-s check before the stimuli
  2. LBNP is applied stepwise with 11.1 mmHg/15 s decrement to -100 mmHg, and then this value is sustained for 120 s
  3. 180-second phase of rest between stimuli
  4. 75°-HUT (5°/s) for 120 s after a 15-s reversing of the gravity vector (-30°)
  5. 180-second phase of rest between stimuli
  6. 75°-HUT (5°/s) accompanied by an exposure to an LBNP of -60 mmHg increased linearly by -4 mmHg/s, and then this value is sustained for 120 s during HUT
  7. 120-s check after the stimuli

干预措施: Lower body negative pressure (LBNP) (Other)

Stimuli of slowly increasing intensities

Experimental
  1. 300-s check before the stimuli
  2. LBNP is applied stepwise with 11.1 mmHg/15 s decrement to -100 mmHg, and then this value is sustained for 120 s
  3. 180-second phase of rest between stimuli
  4. 75°-HUT (5°/s) for 120 s after a 15-s reversing of the gravity vector (-30°)
  5. 180-second phase of rest between stimuli
  6. 75°-HUT (5°/s) accompanied by an exposure to an LBNP of -60 mmHg increased linearly by -4 mmHg/s, and then this value is sustained for 120 s during HUT
  7. 120-s check after the stimuli

干预措施: Head down tilt (HDT) (Other)

Stimuli of slowly increasing intensities

Experimental
  1. 300-s check before the stimuli
  2. LBNP is applied stepwise with 11.1 mmHg/15 s decrement to -100 mmHg, and then this value is sustained for 120 s
  3. 180-second phase of rest between stimuli
  4. 75°-HUT (5°/s) for 120 s after a 15-s reversing of the gravity vector (-30°)
  5. 180-second phase of rest between stimuli
  6. 75°-HUT (5°/s) accompanied by an exposure to an LBNP of -60 mmHg increased linearly by -4 mmHg/s, and then this value is sustained for 120 s during HUT
  7. 120-s check after the stimuli

干预措施: Tilt table (Device)

Stimuli of slowly increasing intensities

Experimental
  1. 300-s check before the stimuli
  2. LBNP is applied stepwise with 11.1 mmHg/15 s decrement to -100 mmHg, and then this value is sustained for 120 s
  3. 180-second phase of rest between stimuli
  4. 75°-HUT (5°/s) for 120 s after a 15-s reversing of the gravity vector (-30°)
  5. 180-second phase of rest between stimuli
  6. 75°-HUT (5°/s) accompanied by an exposure to an LBNP of -60 mmHg increased linearly by -4 mmHg/s, and then this value is sustained for 120 s during HUT
  7. 120-s check after the stimuli

干预措施: LBNP chamber (Device)

Stimuli of rapidly increasing intensities

Experimental
  1. 120-s check before the stimuli
  2. 75°-HUT (45°/s) for 60 s after a 3-s reversing of the gravity vector (-30°)
  3. 180-second phase of rest between stimuli
  4. LBNP decreases linearly by -20 mmHg/s to -100 mmHg, and then this value is sustained for 60 s.
  5. 180 second phase of rest between stimuli
  6. push-pull, i.e., 3 x 75°-HUT (45°/s) preceded by -30°-HDT (45°/s) and accompanied by an exposure to an LBNP of -60 mmHg decreased linearly by -20 mmHg/s, and then this value is sustained for 30 s during HUT
  7. 120-s check after the stimuli

干预措施: Head up tilt (HUT) (Other)

Stimuli of rapidly increasing intensities

Experimental
  1. 120-s check before the stimuli
  2. 75°-HUT (45°/s) for 60 s after a 3-s reversing of the gravity vector (-30°)
  3. 180-second phase of rest between stimuli
  4. LBNP decreases linearly by -20 mmHg/s to -100 mmHg, and then this value is sustained for 60 s.
  5. 180 second phase of rest between stimuli
  6. push-pull, i.e., 3 x 75°-HUT (45°/s) preceded by -30°-HDT (45°/s) and accompanied by an exposure to an LBNP of -60 mmHg decreased linearly by -20 mmHg/s, and then this value is sustained for 30 s during HUT
  7. 120-s check after the stimuli

干预措施: Lower body negative pressure (LBNP) (Other)

Stimuli of rapidly increasing intensities

Experimental
  1. 120-s check before the stimuli
  2. 75°-HUT (45°/s) for 60 s after a 3-s reversing of the gravity vector (-30°)
  3. 180-second phase of rest between stimuli
  4. LBNP decreases linearly by -20 mmHg/s to -100 mmHg, and then this value is sustained for 60 s.
  5. 180 second phase of rest between stimuli
  6. push-pull, i.e., 3 x 75°-HUT (45°/s) preceded by -30°-HDT (45°/s) and accompanied by an exposure to an LBNP of -60 mmHg decreased linearly by -20 mmHg/s, and then this value is sustained for 30 s during HUT
  7. 120-s check after the stimuli

干预措施: Head down tilt (HDT) (Other)

Stimuli of rapidly increasing intensities

Experimental
  1. 120-s check before the stimuli
  2. 75°-HUT (45°/s) for 60 s after a 3-s reversing of the gravity vector (-30°)
  3. 180-second phase of rest between stimuli
  4. LBNP decreases linearly by -20 mmHg/s to -100 mmHg, and then this value is sustained for 60 s.
  5. 180 second phase of rest between stimuli
  6. push-pull, i.e., 3 x 75°-HUT (45°/s) preceded by -30°-HDT (45°/s) and accompanied by an exposure to an LBNP of -60 mmHg decreased linearly by -20 mmHg/s, and then this value is sustained for 30 s during HUT
  7. 120-s check after the stimuli

干预措施: Tilt table (Device)

Stimuli of rapidly increasing intensities

Experimental
  1. 120-s check before the stimuli
  2. 75°-HUT (45°/s) for 60 s after a 3-s reversing of the gravity vector (-30°)
  3. 180-second phase of rest between stimuli
  4. LBNP decreases linearly by -20 mmHg/s to -100 mmHg, and then this value is sustained for 60 s.
  5. 180 second phase of rest between stimuli
  6. push-pull, i.e., 3 x 75°-HUT (45°/s) preceded by -30°-HDT (45°/s) and accompanied by an exposure to an LBNP of -60 mmHg decreased linearly by -20 mmHg/s, and then this value is sustained for 30 s during HUT
  7. 120-s check after the stimuli

干预措施: LBNP chamber (Device)

结局指标

主要结局

HR

时间窗: 24 minutes (scenario I)

Heart rate in beats per minute

DBP

时间窗: 24 minutes (scenario I)

Diastolic blood pressure in millimeters of mercury

SV

时间窗: 24 minutes (scenario I)

Stroke volume in milliliters

LVET

时间窗: 24 minutes (scenario I)

Left ventricular ejection time in milliseconds

TPR

时间窗: 24 minutes (scenario I)

Total peripheral resistance in medical units

IBI

时间窗: 24 minutes (scenario I)

Inter-beat interval in seconds

MAP

时间窗: 24 minutes (scenario I)

Mean arterial pressure in millimeters of mercury

CO

时间窗: 24 minutes (scenario I)

Cardiac output in liters per minute

RPP

时间窗: 24 minutes (scenario I)

Rate pressure product in millimeters of mercury

SBP

时间窗: 24 minutes (scenario I)

Systolic blood pressure in millimeters of mercury

次要结局

  • ΔC_HbO2(16 minutes (scenario II))
  • ΔC_Hb(16 minutes (scenario II))
  • dZ/dt_H(16 minutes (scenario II))
  • Z0_T(16 minutes (scenario II))
  • Z0_H(16 minutes (scenario II))
  • ΔC_tot(16 minutes (scenario II))
  • dZ/dt_T(16 minutes (scenario II))

研究者

发起方
Military Institute of Aviation Medicine
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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