Therapeutic Oxygen for Gastrointestinal Atony (TOGA)

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT03386136
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Actual Duration (Months): 20.7
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ileus; Ogilvie Syndrome; Small Bowel Obstruction	Drug: 100% Oxygen	Phase 1

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Therapeutic Oxygen for Gastrointestinal Atony (TOGA): Pilot Trial - Management of Acute Colonic Pseudo-Obstruction With Oxygen Supplementation
• Actual Study Start Date: Jan 25, 2018
• Actual Primary Completion Date: Oct 17, 2019
• Actual Study Completion Date: Oct 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hospitalized Ileus or Pseudo-Obstruction Patient 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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. Demonstrates No Resolution of Ileus [24 - 30 hours after initial TOGA]

   A second treatment with TOGA will be offered.

2. 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.

3. Need for endoscopic or surgical intervention [24 - 30 hours after initial TOGA]

   Worsening of ileus after initial treatment, requiring surgical or endoscopic intervention

4. Length of Hospital Stay [up to 100 weeks]

   Length of stay, measured at the end of hospitalization

5. Patient Complaints [Up to 48 hours]

   Recording of patient perception/tolerance [daily] of TOGA.

6. 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.

7. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts 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%.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

• University of Florida

Investigators

• Principal Investigator: Brian C. Weiner, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT03386136
• Other Study ID Numbers: IRB201701709
• First Posted: Dec 29, 2017
• Last Update Posted: Dec 12, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by University of Florida: bowel ischemia; bowel perforation
• Additional relevant MeSH terms: Intestinal Obstruction; Colonic Pseudo-Obstruction; Ileus

Study Results

No Results Posted as of Dec 12, 2019