Status:
COMPLETED
Therapeutic Oxygen for Gastrointestinal Atony (TOGA)
Lead Sponsor:
University of Florida
Conditions:
Ileus
Ogilvie Syndrome
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
This study is a non invasive study to see if 100% oxygen therapy will help to resolve an intestinal obstruction.
Detailed Description
TOGA involves the provision of a 6- hour treatment with 100% oxygen via non breather mask to hospitalized patients with ileus, small bowel obstruction and/or colonic pseudo-obstruction will be a usefu...
Eligibility Criteria
Inclusion
- 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 \[to eliminate patients with trivial ileus not requiring advanced intervention\]
Exclusion
- 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%.
Key Trial Info
Start Date :
January 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03386136
Start Date
January 25 2018
End Date
October 17 2019
Last Update
December 12 2019
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610