Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease

The Second Hospital of Nanjing Medical University100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Chronic Ischemic-Hypoxic Enteropathy

Interventions

Oxygen (O2) -Sham groupOTHER

Subjects will receive interventions in a crossover manner at three separate time points over one day as follows: Time 1: 500 mL of oxygen (flow rate: 1 L/min) Time 2: 500 mL of no air (no oxygen) Time 3: 500 mL of oxygen (flow rate: 1 L/min)

Sham -Oxygen (O2) groupOTHER

Subjects will receive interventions in a crossover manner at three separate time points over one day as follows: Time 1: 500 mL of no air (no oxygen) Time 2: 500 mL of oxygen (flow rate: 1 L/min) Time 3: 500 mL of oxygen (flow rate: 1 L/min)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Changes in arterial blood gas

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