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临床试验/NCT03412045
NCT03412045已完成不适用

Hyperbaric Oxygen Therapy in Sickle Cell Pain

University of Nebraska2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2022年9月1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
入组人数
8
试验地点
2
主要终点
Pain Assessment per Treatment

研究概览

简要总结

Sickle cell anemia is a genetic blood disorder where red blood cells are abnormally shaped, crescent- or sickle-shaped, instead of the normal, round shape. This misshapen cell is rigid and sticky, causing them to clump together and block small blood vessels. This blockage can lead to pain, infections, and organ damage, and the shortened lifespan of sickle cells causes anemia. The purpose of this study is to explore if hyperbaric oxygen (HBO) therapy would decrease pain and hospital length of stay associated with acute sickle cell pain crisis. Adults presenting with an uncomplicated acute pain crisis (i.e., acute chest syndrome, acute myocardial infarction/stroke) would be eligible. The intervention would be 1-3 hyperbaric oxygen sessions depending on response to therapy. Each treatment session will be approximately two hours in length. Evaluation would be through participants' self--assessment via the visual analog scale for pain level before and after treatments as well as tracking length of stay in the hospital.

详细描述

Sickle cell anemia is a genetic blood disorder where red blood cells are abnormally shaped, crescent- or sickle-shaped, instead of the normal, round shape. This misshapen cell is rigid and sticky, causing them to clump together and block small blood vessels. This blockage can lead to pain, infections, and organ damage, and the shortened lifespan of sickle cells causes anemia. Previous study suggest that hyperbaric oxygen (HBO) may help ameliorate symptoms and have positive effects for sickle cell patients. In addition, although a few studies did discuss pain reduction associated with HBO therapy, results are conflicting, and sample sizes are too small to carry any weight when compared against each other. No information has been gathered to date about how HBO therapy this may affect hospital length of stay. The purpose of this study is to determine if HBO treatment in participants experiencing sickle cell crisis would produce a decrease in pain and decrease in hospital length of stay.

Current standard of care at University of Nebraska Medical Center (UNMC) and Nebraska Medicine for patients identified as having sickle cell and experiencing an uncomplicated pain crisis that is not responding to acute treatment in the emergency department over the course of a few hours is to admit the patient to the hematology service. They would receive IV fluid administration, oxygen, and usually large doses of pain medications, until their pain subsides. Patient's complete blood count (CBC) and comprehensive metabolic panel (CMP) are monitored during this time for acute changes. Once pain has subsided and no signs of complications such as infection, etc. are found, the patient is discharged with follow up in hematology clinic.

Interventions would be 1-3 hyperbaric oxygen sessions depending on response to the therapy. Each treatment session will be approximately two hours in length. Evaluation would be through participants' self-assessment via the visual analog scale for pain level before and after treatments as well as tracking length of stay in the hospital. Changes in pain ratings will use the visual pain scale of 0 to 100, where 0 is no pain and 100 being maximal pain imaginable for that participant. Pain ratings will be compiled and compared 1 hour before and after each treatment and from daily pain ratings assessed at hospital admission until discharge. Hospital length of stay is recorded for each participant from date of randomization until date of discharge or date of death from any cause and compared to data extracted from the electronic health record system EPIC.

研究设计

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

入排标准

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

入选标准

  • 19 years old or older
  • Present with an uncomplicated sickle cell crisis at admission friom the emergency department

排除标准

  • < 19 years old
  • pregnant female
  • complicated sickle cell crisis present (i.e., concomitant MI, stroke, acute chest syndrome at time of presentation)

研究组 & 干预措施

treatment

Experimental

This preliminary study will be a convenience sample of patients admitted to hospital for vaso-occlusive sickle cell crisis to be treated with hyperbaric oxygen (HBO), the intervention, in an effort to ameliorate pain and shorten the length of hospital stay.

干预措施: hyperbaric oxygen therapy (Device)

结局指标

主要结局

Pain Assessment per Treatment

时间窗: one hour before and after each hyperbaric treatment

Change in pain rating will be determined within one hour before and after each hyperbaric oxygen (HBO) treatment. The pain scale is 0-100, 0 being no pain and 100 being maximal pain imaginable for that participant. Pain assessments before and after each HBO treatment will be compiled and compared to determine treatment effectiveness.

Analgesic Received in MME (Morphine Milligram Equivalents)

时间窗: admission to discharge

Comparison of total analgesic administered to patient during control hospital stay versus intervention HBO treatment hospital stay. Each patient serves as their own control. The patient receives HBO treatment during one hospital admission, and the amount of analgesic received is compared to the patient's previous hospital admission.

次要结局

  • Hospital Length of Stay(up to 1 month)
  • Pain Assessment for All Treatments(up to 1 month (expected average of 3 days))
  • Hospital Length of Stay(admission to discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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