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临床试验/CTRI/2026/02/103544
CTRI/2026/02/103544尚未招募不适用

Evaluating the effects of Perioperative hyperoxic intermittent stimuli on reticulocyte levels in head and neck cancer patients: a Randomized controlled trial

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年2月21日最近更新:

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

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Muralidhara P

All India Institute Of Medical Sciences, New Delhi

研究点 (1)

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