Therapeutic Oxygen for Gastrointestinal Atony (TOGA)
United States17 participantsStarted 2018-01-25
Plain-language summary
This study is a non invasive study to see if 100% oxygen therapy will help to resolve an intestinal obstruction.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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%.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.