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Therapeutic Oxygen for Gastrointestinal Atony (TOGA)

NCT ID: NCT03386136

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-25

Study Completion Date

2019-10-17

Brief Summary

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

Detailed Description

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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

Conditions

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Ileus Ogilvie Syndrome Small Bowel Obstruction

Keywords

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bowel ischemia bowel perforation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

100% Oxygen

Intervention Type DRUG

To provide hospitalized ileus or pseudo-obstruction patient with 100% oxygen via non-rebreather face mask, for 6 hours

Interventions

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100% Oxygen

To provide hospitalized ileus or pseudo-obstruction patient with 100% oxygen via non-rebreather face mask, for 6 hours

Intervention Type DRUG

Eligibility Criteria

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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%.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian C. Weiner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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Weiner B, Forsmark C, Khular V, Bauman A, Sutchu S, Banerjee D, Westerveld D, Zhang W, Jacobson M, Grajo J. TOGA Therapeutic Oxygen for Gastrointestinal Atony. Gastro Hep Adv. 2024 Jan 3;3(3):402-409. doi: 10.1016/j.gastha.2023.12.013. eCollection 2024.

Reference Type DERIVED
PMID: 39131150 (View on PubMed)

Other Identifiers

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IRB201701709

Identifier Type: -

Identifier Source: org_study_id