Clinical trial NCT03386136: Therapeutic Oxygen for Gastrointestinal Atony (TOGA)
Official title: Therapeutic Oxygen for Gastrointestinal Atony (TOGA): Pilot Trial - Management of Acute Colonic Pseudo-Obstruction With Oxygen Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ileus
Ogilvie Syndrome
Small Bowel Obstruction
Keywords: bowel ischemia
bowel perforation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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%.

Primary outcomes:
measure: Changes in Diameter of Colon
timeFrame: 6 - 24 hours
measure: Changes in Diameter of the Small Bowel
timeFrame: 6 - 24 hours
Secondary outcomes:
measure: Demonstrates No Resolution of Ileus
timeFrame: 24 - 30 hours after initial TOGA
measure: Worsening of Ileus
timeFrame: 24 - 30 hours after initial TOGA
measure: Need for endoscopic or surgical intervention
timeFrame: 24 - 30 hours after initial TOGA
measure: Length of Hospital Stay
timeFrame: up to 100 weeks
measure: Patient Complaints
timeFrame: Up to 48 hours
measure: Patient Pain Measurement
timeFrame: Up to 48 hours
measure: Medication Measurement
timeFrame: 24 hours before through 24 hours after TOGA
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Brian C. Weiner, MD
role: PRINCIPAL_INVESTIGATOR
References: