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Completed

NCT Number: NCT03386136

Therapeutic Oxygen for Gastrointestinal Atony (TOGA)

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

100% Oxygen

Drug

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Acronym: TOGA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 29, 2017
Registry last updated
Dec 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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