Therapeutic Oxygen for Gastrointestinal Atony (TOGA)



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 100
Updated:2/1/2019
Start Date:January 25, 2018
End Date:October 2019
Contact:April Goddard, PA
Email:april.goddard@medicine.ufl.edu
Phone:352-273-9483

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Therapeutic Oxygen for Gastrointestinal Atony (TOGA): Pilot Trial - Management of Acute Colonic Pseudo-Obstruction With Oxygen Supplementation

This study is a non invasive study to see if 100% oxygen therapy will help to resolve an
intestinal obstruction.

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 useful supplemental therapy, decreasing the diameter of the intestinal lumen and
enhancing resolution of ileus/pseudo-obstruction

Inclusion Criteria:

- 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 Criteria:

- 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%.
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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