search
Back to results

Therapeutic Oxygen for Gastrointestinal Atony (TOGA) (TOGA)

Primary Purpose

Ileus, Ogilvie Syndrome, Small Bowel Obstruction

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
100% Oxygen
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ileus focused on measuring bowel ischemia, bowel perforation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hospitalized Ileus or Pseudo-Obstruction Patient

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Demonstrates No Resolution of Ileus
A second treatment with TOGA will be offered.
Worsening of Ileus
Worsening of ileus after initial treatment but not requiring surgical or endoscopic intervention, will be offered a second treatment of TOGA.
Need for endoscopic or surgical intervention
Worsening of ileus after initial treatment, requiring surgical or endoscopic intervention
Length of Hospital Stay
Length of stay, measured at the end of hospitalization
Patient Complaints
Recording of patient perception/tolerance [daily] of TOGA.
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.
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)

Full Information

First Posted
November 28, 2017
Last Updated
December 10, 2019
Sponsor
University of Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT03386136
Brief Title
Therapeutic Oxygen for Gastrointestinal Atony (TOGA)
Acronym
TOGA
Official Title
Therapeutic Oxygen for Gastrointestinal Atony (TOGA): Pilot Trial - Management of Acute Colonic Pseudo-Obstruction With Oxygen Supplementation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
October 17, 2019 (Actual)
Study Completion Date
October 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus, Ogilvie Syndrome, Small Bowel Obstruction
Keywords
bowel ischemia, bowel perforation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hospitalized Ileus or Pseudo-Obstruction Patient
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
100% Oxygen
Intervention Description
To provide hospitalized ileus or pseudo-obstruction patient with 100% oxygen via non-rebreather face mask, for 6 hours
Primary Outcome Measure Information:
Title
Changes in Diameter of Colon
Description
X-ray of kidney, ureter and bladder (KUB) to determine maximal cecal diameter, maximal mid-transverse colon diameter, maximal mid-sigmoid colon diameter.
Time Frame
6 - 24 hours
Title
Changes in Diameter of the Small Bowel
Description
X-ray of kidney, ureter and bladder (KUB) to determine maximal cecal diameter, maximal mid-transverse colon diameter, maximal mid-sigmoid colon diameter.
Time Frame
6 - 24 hours
Secondary Outcome Measure Information:
Title
Demonstrates No Resolution of Ileus
Description
A second treatment with TOGA will be offered.
Time Frame
24 - 30 hours after initial TOGA
Title
Worsening of Ileus
Description
Worsening of ileus after initial treatment but not requiring surgical or endoscopic intervention, will be offered a second treatment of TOGA.
Time Frame
24 - 30 hours after initial TOGA
Title
Need for endoscopic or surgical intervention
Description
Worsening of ileus after initial treatment, requiring surgical or endoscopic intervention
Time Frame
24 - 30 hours after initial TOGA
Title
Length of Hospital Stay
Description
Length of stay, measured at the end of hospitalization
Time Frame
up to 100 weeks
Title
Patient Complaints
Description
Recording of patient perception/tolerance [daily] of TOGA.
Time Frame
Up to 48 hours
Title
Patient Pain Measurement
Description
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.
Time Frame
Up to 48 hours
Title
Medication Measurement
Description
Documenting medication requirements for patients exposed to TOGA.(past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable)
Time Frame
24 hours before through 24 hours after TOGA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian C. Weiner, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Therapeutic Oxygen for Gastrointestinal Atony (TOGA)

We'll reach out to this number within 24 hrs