Therapeutic Oxygen for Gastrointestinal Atony (TOGA)
Completed · Phase 1
Conditions studied: Ileus, Ogilvie Syndrome, Small Bowel Obstruction
In brief
This study is a non invasive study to see if 100% oxygen therapy will help to resolve an intestinal obstruction.
Key facts
- Study ID
- NCT03386136
- Run by
- University of Florida
- People needed
- 17
- Starts
- 2018-01-25
- Expected to finish
- 2019-10-17
- Last updated by the study team
- 2019-12-12
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- patient or health proxy has been adequately informed of risks and benefits and agrees to his/her participation in the study.
- patient is a hospitalized inpatient diagnosed with ileus, bowel obstruction or colonic pseudo-obstruction [clinician interpretation or small bowel diameter ≥3.5 cm, cecal diameter ≥ 9 cm, sigmoid colon diameter ≥ 6 cm].
- patient is clinically and hemodynamically stable
- patient does not require supplemental oxygen greater than 2 liters per minute via nasal cannula
- patient does not have any respiratory contraindications to 100% oxygen
- failure to respond to non-surgical/non-endoscopic therapy for at least 24 hours, therapy at discretion of treating physician [to eliminate patients with trivial ileus not requiring advanced intervention]
You may not qualify if…
- patient is not expected to survive in the short term.
- patient is a pregnant or lactating woman.
- patient presents with severe or unstable psychiatric disorders.
- patient is participating in concomitant research studies that would interfere with this study.
- patient is an alcohol or drug abuser.
- respirator support required.
- unable to tolerate 100% oxygen for respiratory reasons or any other reasons.
- perforation of the viscus.
- inability to obtain informed consent.
- hypoxemia, as in room air oxygen saturation less than 90%.
Where it is running
- University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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