NCT03386136

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2019

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

1.7 years

First QC Date

November 28, 2017

Last Update Submit

December 10, 2019

Conditions

IleusOgilvie SyndromeSmall Bowel Obstruction

Keywords

bowel ischemiabowel perforation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Demonstrates No Resolution of Ileus

    24 - 30 hours after initial TOGA

  • Worsening of Ileus

    24 - 30 hours after initial TOGA

  • Need for endoscopic or surgical intervention

    24 - 30 hours after initial TOGA

  • Length of Hospital Stay

    up to 100 weeks

  • Patient Complaints

    Up to 48 hours

  • +2 more secondary outcomes

Study Arms (1)

Hospitalized Ileus or Pseudo-Obstruction Patient

EXPERIMENTAL

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

Interventions

100% OxygenDRUG

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

Hospitalized Ileus or Pseudo-Obstruction Patient

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \[to eliminate patients with trivial ileus not requiring advanced intervention\]

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • 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.

    PMID: 39131150DERIVED

MeSH Terms

Conditions

IleusColonic Pseudo-ObstructionIntestinal Perforation

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesColonic Diseases, FunctionalColonic DiseasesIntestinal Pseudo-Obstruction

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Brian C. Weiner, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2017

First Posted

December 29, 2017

Study Start

January 25, 2018

Primary Completion

October 17, 2019

Study Completion

October 17, 2019

Last Updated

December 12, 2019

Record last verified: 2019-12

Locations

US(1)