A Phase 1 interventional study of 100% Oxygen in Ileus, Ogilvie Syndrome and Small Bowel Obstruction, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-12-12.
Sponsored by University of Florida · Phase 1, Interventional, and Treatment
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
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's enrollment of 17 is below the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hospitalized inpatient diagnosed with ileus, bowel obstruction or colonic pseudo-obstruction \[clinician interpretation or small bowel diameter ≥3.5 cm, cecal diameter ≥ 9 cm, sigmoid colon diameter ≥ 6 cm\] provided with 100% oxygen via non-rebreather face mask, for 6 hours
Drug: 100% Oxygen
To provide hospitalized ileus or pseudo-obstruction patient with 100% oxygen via non-rebreather face mask, for 6 hours
Changes in Diameter of Colon
X-ray of kidney, ureter and bladder (KUB) to determine maximal cecal diameter, maximal mid-transverse colon diameter, maximal mid-sigmoid colon diameter.
Time frame: 6 - 24 hours
Changes in Diameter of the Small Bowel
X-ray of kidney, ureter and bladder (KUB) to determine maximal cecal diameter, maximal mid-transverse colon diameter, maximal mid-sigmoid colon diameter.
Time frame: 6 - 24 hours
Demonstrates No Resolution of Ileus
A second treatment with TOGA will be offered.
Time frame: 24 - 30 hours after initial TOGA
Worsening of Ileus
Worsening of ileus after initial treatment but not requiring surgical or endoscopic intervention, will be offered a second treatment of TOGA.
Time frame: 24 - 30 hours after initial TOGA
Need for endoscopic or surgical intervention
Worsening of ileus after initial treatment, requiring surgical or endoscopic intervention
Time frame: 24 - 30 hours after initial TOGA
Length of Hospital Stay
Length of stay, measured at the end of hospitalization
Time frame: up to 100 weeks
Patient Complaints
Recording of patient perception/tolerance \[daily\] of TOGA.
Time frame: Up to 48 hours
Patient Pain Measurement
Patient pain measurement determined subjectively through a visual analogue scale (VAS) scale of 0 (no pain) to 10 (worst pain imaginable) taken before and after TOGA treatment.
Time frame: Up to 48 hours
Medication Measurement
Documenting medication requirements for patients exposed to TOGA.(past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable)
Time frame: 24 hours before through 24 hours after TOGA
Ran from Jan 2018 to primary completion in Oct 2019, 20 months.
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxygen