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
Qualifiers
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
Treatments tested in this trial
- Oxygen 30 %
- Air
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov