Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Second Hospital of Nanjing Medical University
About this trial
This multicenter, randomized, double-blind, placebo-controlled clinical trial aimed to investigate the efficacy and safety of gut oxygen therapy in the treatment of ischemic-hypoxic bowel disease using deep intestinal catheterization as a targeted route for gut oxygen delivery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of intestinal ischemia and hypoxia-related diseases caused by conditions such as ischemic bowel disease, heart failure, etc., presenting with recurrent or persistent abdominal pain and/or distension, and difficulty in defecation. Examples include: heart failure-related defecation difficulty, severe malnutrition combined with defecation difficulty, acute ischemic bowel disease, and chronic ischemic bowel disease.
At least able to perform bedside activities and able to defecate in conventional positions (sitting or squatting).
Age ≥18 years, and able to voluntarily sign informed consent.
Disqualifiers
Acute intestinal emergencies such as acute intestinal obstruction, intestinal perforation, or active massive gastrointestinal bleeding.
Intestinal fistula.
History of abdominal surgery within the recent past (<1 month).
Severe uncontrolled arrhythmia or respiratory failure.
Trial design
Design model
Parallel
Treatments tested in this trial
Oxygen 30 %
Other interventionPatients will receive 250mL of oxygen (30%) through a deep intestinal catheterization four times a day for 5 days.
Air
Other interventionPatients will receive 250mL of air through a deep intestinal catheterization four times a day for 5 days.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The changes of core-symptom score in patients with ischemic-hypoxic bowel disease after intervention.
The severity of core symptoms (including abdominal pain, abdominal distention, and difficult defecation) was assessed using the VAS score, which ranged from 0 to 10 for each symptom, with higher scores indicating more severe symptoms, and the total score ranged from 0 to 30.
Time frame
Five-day after interventionSecondary outcomes
1
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.
Time frame
Five-day after intervention2
The incidence rate of adverse events
The number of adverse reactions reported by subjects from the start of treatment to the end of follow-up
Time frame
Five-day after intervention3
Change in intestinal movement frequency
The movement frequency of the large intestine (ascending colon, transverse colon, and descending colon) is detected using an intestinal motility detector. The change in movement frequency between the two groups will be compared.
Time frame
Baseline and 30 minutes after the last intervention on day 54
Change in intestinal movement amplitude
The movement amplitude of the large intestine (ascending colon, transverse colon, and descending colon) is detected using an intestinal motility detector. The change in movement amplitude between the two groups will be compared.
Time frame
Baseline and 30 minutes after the last intervention on day 5.Sponsors and contacts
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Source ClinicalTrials.gov