Chronic Ischemic-Hypoxic Enteropathy
Conditions
Keywords
ischemic bowel disease, heart failure, abdominal pain, abdominal distension, difficult defecation
Brief summary
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.
Detailed description
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.
Interventions
OTHEROxygen (O2) -Sham group
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)
OTHERSham -Oxygen (O2) group
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)
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in arterial blood gas | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in electrocardiographic data | Perioperative/Periprocedural | 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 | Perioperative/Periprocedural | 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. | Perioperative/Periprocedural | 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 | Perioperative/Periprocedural | The number of adverse reactions reported from the start of treatment to the end of follow-up |
| The changes in gut microbiota composition and metabolites before and after treatment. | Perioperative/Periprocedural | The 16s-RNA or meta-analysis of gut microbiota will be used. |
Countries
China
Contacts
CONTACTFaming Zhang, PhD
Outcome results
None listed