Evaluating the effects of Perioperative hyperoxic intermittent stimuli on reticulocyte levels in head and neck cancer patients: a Randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
研究概览
简要总结
Anemia is a reduction in hemoglobin or hematocrit or RBC count. In cancer patients it is more common in the peri-op period. It can warrant a blood transfusion, which has its own side effects.
The etiology of anemia in cancer patients is multifactorial. Erythropoietin is a hormone secreted in response to low partial pressure of oxygen and low hemoglobin levels.
Recombinant erythropoietin and the normobaric oxygen paradox are two such interventions to prevent and treat anemia.
Normobaric oxygen paradox is hypothesized to increase EPO production. NOP involves intermittent exposure to higher oxygen levels at normal atmospheric pressure. NOP has been shown to be effective in enhancing the hemoglobin levels by increasing reticulocyte counts in non-anemic healthy volunteers.
The frequency, duration, timing, interval of hyperoxia and normoxia that elicit this mechanism are still debated. The strength of oxygen is also still unclear.
Also, the neutrophil-to-lymphocyte ratio is a biomarker of inflammation status. An elevated NLR is associated with poorer prognosis in cancer patients.
This study will be conducted to evaluate whether NOP mechanism can increase reticulocyte count, thus indicating increased EPO production in head and neck cancer patients undergoing surgeries. In addition, we also would like to evaluate NLR trends in the preop and post surgery in cancer patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •The study will include adult patients (aged 18 or older) eligible for head and neck oncological surgery.
排除标准
- •Severe renal insufficiency
- •Transfusion of red blood cells, plasma during the perioperative period,
- •Bleeding requiring repeated transfusions during or after surgery,
- •Severe respiratory syndrome necessitating continuous oxygen,
- •Intolerance to an oxygen mask.
研究者
Muralidhara P
All India Institute Of Medical Sciences, New Delhi
