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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospitalized Ileus or Pseudo-Obstruction Patient | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100% Oxygen | Drug | To provide hospitalized ileus or pseudo-obstruction patient with 100% oxygen via non-rebreather face mask, for 6 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 6 - 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrates No Resolution of Ileus | A second treatment with TOGA will be offered. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian C. Weiner, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39131150 | Derived | Weiner B, Forsmark C, Khular V, Bauman A, Sutchu S, Banerjee D, Westerveld D, Zhang W, Jacobson M, Grajo J. TOGA Therapeutic Oxygen for Gastrointestinal Atony. Gastro Hep Adv. 2024 Jan 3;3(3):402-409. doi: 10.1016/j.gastha.2023.12.013. eCollection 2024. |
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| ID | Term |
|---|---|
| D045823 | Ileus |
| D003112 | Colonic Pseudo-Obstruction |
| D007416 | Intestinal Perforation |
| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| 24 - 30 hours after initial TOGA |
| Need for endoscopic or surgical intervention | Worsening of ileus after initial treatment, requiring surgical or endoscopic intervention | 24 - 30 hours after initial TOGA |
| Length of Hospital Stay | Length of stay, measured at the end of hospitalization | up to 100 weeks |
| Patient Complaints | Recording of patient perception/tolerance [daily] of TOGA. | 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. | 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) | 24 hours before through 24 hours after TOGA |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007418 | Intestinal Pseudo-Obstruction |