Therapeutic Oxygen for Gastrointestinal Atony (TOGA) (TOGA)

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

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

Study Overview

• Status: Completed
• Conditions: Ileus; Small Bowel Obstruction; Ogilvie Syndrome
• Intervention / Treatment: Drug: 100% Oxygen

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2018
• Primary Completion (Actual): October 17, 2019
• Study Completion (Actual): October 17, 2019

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: bowel perforation; bowel ischemia
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Intestinal Pseudo-Obstruction; Ileus; Intestinal Obstruction; Colonic Pseudo-Obstruction
• Other Study ID Numbers: IRB201701709

Drug and device information, study documents

• 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