Efficacy and Safety of Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease: A Single-center, Double-blind, Randomized, Intra-individual Crossover Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in arterial blood gas
研究概览
简要总结
This single-center, double-blind, randomized, intra-individual crossover controlled study aims to investigate the efficacy and safety of intestinal oxygen therapy via a deep intestinal catheter as a targeted route for intestinal oxygen delivery in the treatment of ischemic-hypoxic enteropathy, and simultaneously to explore and verify the chronobiological differences. Data have been obtained from the study based on the first version of our pilot study. Considering ethics and cost-effectiveness, a new protocol needs to be designed to achieve the research goals with minimal intervention, minimal cost, and the smallest sample size.
详细描述
Eligible subjects meeting all inclusion criteria and none of the exclusion criteria will be randomized in a crossover manner within the individual to receive, via a deep intestinal catheter, either 500 mL of oxygen or placebo (sham group), administered at three separate time points over the course of one day. The data of test results before and after treatment were collected to evaluate the efficacy and safety of gut oxygen therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite diagnosis of chronic heart failure or obstructive sleep apnea (OSA) with chronic hypoxia;
- •Comorbid intestinal dysmotility (abdominal distension, constipation, diarrhea, or abdominal pain);
- •Disease duration ≥1 month with poor response to conventional treatment;
- •Tolerability of transendoscopic enteral tubing (TET) with successful placement of the tube at the ileocecal junction;
- •Age 18-80 years;
- •Able to cooperate with bed rest therapy and provide written informed consent.
排除标准
- •Oxygenation index >400 without supplemental oxygen and/or resting oxygen saturation ≥96%;
- •Primary organic gastrointestinal diseases, intestinal obstruction, inflammatory bowel disease, or severe hepatic/renal failure;
- •Hemodynamically unstable, unable to tolerate sequential intervention (time-sequenced intervention);
- •Presence of cough or spinal disorders that prevent maintaining a resting state during bed rest;
- •Failure of arterial catheterization or endoscopic tube placement;
- •Mental or cognitive impairment that precludes cooperation with assessments.
研究组 & 干预措施
Crossover Sequence A - O2 then Sham
Eligible subjects meeting all inclusion criteria and none of the exclusion criteria randomized to this sequence will receive interventions at three separate time points over one day via a deep intestinal catheter
干预措施: Oxygen (O2) -Sham group (Other)
Crossover Sequence B - Sham then Oxygen (O2)
Eligible subjects meeting all inclusion criteria and none of the exclusion criteria randomized to this sequence will receive reverse interventions at three separate time points over one day via a deep intestinal catheter.
干预措施: Sham -Oxygen (O2) group (Other)
结局指标
主要结局
Changes in arterial blood gas
时间窗: Perioperative/Periprocedural
Arterial blood gas analysis results, including partial pressure of oxygen, oxygen concentration, partial pressure of carbon dioxide, oxygenation index, and concentrations of various ions and electrolytes, were obtained at baseline and at intermittent time points within a 30-minute period
次要结局
- Changes in electrocardiographic data(Perioperative/Periprocedural)
- Changes in electroencephalographic data(Perioperative/Periprocedural)
- Overall patient satisfaction with intervention.(Perioperative/Periprocedural)
- The incidence rate of adverse events(Perioperative/Periprocedural)
- The changes in gut microbiota composition and metabolites before and after treatment.(Perioperative/Periprocedural)
研究者
Faming Zhang
Professor
The Second Hospital of Nanjing Medical University