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.
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;
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;
Crossover
Oxygen (O2) -Sham group
Other interventionSubjects 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) group
Other interventionSubjects 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)
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
Changes in electrocardiographic data
Electrocardiographic data, comprising P-wave morphology, QRS complex duration, QT interval, among other relevant indices, were acquired throughout the periprocedural course.
Changes in electroencephalographic data
Electroencephalographic parameters-specifically the wavelengths and amplitudes of alpha, beta, and other relevant frequency bands-were measured throughout the periprocedural course.
Overall patient satisfaction with intervention.
The patients' satisfaction with the treatment was graded into five levels: very dissatisfied, dissatisfied, average, relatively satisfied, and very satisfied. The differences of treatment satisfaction among different groups were compared.
The incidence rate of adverse events
The number of adverse reactions reported from the start of treatment to the end of follow-up
Click on the lead sponsor to view all of their trials.
