Ileus, Ogilvie Syndrome, Small Bowel Obstruction
Conditions
Keywords
bowel ischemia, bowel perforation
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 useful supplemental therapy, decreasing the diameter of the intestinal lumen and enhancing resolution of ileus/pseudo-obstruction
Interventions
DRUG100% Oxygen
To provide hospitalized ileus or pseudo-obstruction patient with 100% oxygen via non-rebreather face mask, for 6 hours
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Diameter of Colon | 6 - 24 hours | X-ray of kidney, ureter and bladder (KUB) to determine maximal cecal diameter, maximal mid-transverse colon diameter, maximal mid-sigmoid colon diameter. |
| Changes in Diameter of the Small Bowel | 6 - 24 hours | X-ray of kidney, ureter and bladder (KUB) to determine maximal cecal diameter, maximal mid-transverse colon diameter, maximal mid-sigmoid colon diameter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for endoscopic or surgical intervention | 24 - 30 hours after initial TOGA | Worsening of ileus after initial treatment, requiring surgical or endoscopic intervention |
| Length of Hospital Stay | up to 100 weeks | Length of stay, measured at the end of hospitalization |
| Demonstrates No Resolution of Ileus | 24 - 30 hours after initial TOGA | A second treatment with TOGA will be offered. |
| Patient Pain Measurement | Up to 48 hours | 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. |
| Medication Measurement | 24 hours before through 24 hours after TOGA | Documenting medication requirements for patients exposed to TOGA.(past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable) |
| Patient Complaints | Up to 48 hours | Recording of patient perception/tolerance \[daily\] of TOGA. |
| Worsening of Ileus | 24 - 30 hours after initial TOGA | Worsening of ileus after initial treatment but not requiring surgical or endoscopic intervention, will be offered a second treatment of TOGA. |
Countries
United States
Outcome results
None listed