Therapeutic Oxygen for Gastrointestinal Atony (TOGA)

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

Detailed Description
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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

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

Conditions
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Ileus, Ogilvie Syndrome, Small Bowel Obstruction

Intervention / Treatment
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* Drug: 100% Oxygen


Participation Criteria
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Eligibility Criteria
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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%.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hospitalized Ileus or Pseudo-Obstruction Patient<br>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<br>* To provide hospitalized ileus or pseudo-obstruction patient with 100% oxygen via non-rebreather face mask, for 6 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bowel ischemia, bowel perforation