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Therapeutic Oxygen for Gastrointestinal Atony (TOGA) (TOGA)

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ClinicalTrials.gov Identifier: NCT03386136
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : January 25, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019


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




Primary Outcome Measures :
  1. Changes in Diameter of Colon [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 24 - 30 hours after initial TOGA ]
    A second treatment with TOGA will be offered.

  2. Worsening of Ileus [ Time Frame: 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 [ Time Frame: 24 - 30 hours after initial TOGA ]
    Worsening of ileus after initial treatment, requiring surgical or endoscopic intervention

  4. Length of Hospital Stay [ Time Frame: up to 100 weeks ]
    Length of stay, measured at the end of hospitalization

  5. Patient Complaints [ Time Frame: Up to 48 hours ]
    Recording of patient perception/tolerance [daily] of TOGA.

  6. Patient Pain Measurement [ Time Frame: 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 [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386136


Contacts
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Contact: April Goddard, PA 352-273-9483 april.goddard@medicine.ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Brian C. Weiner, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03386136     History of Changes
Other Study ID Numbers: IRB201701709
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: October 2018

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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:
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Intestinal Obstruction
Ileus
Colonic Pseudo-Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Pseudo-Obstruction