IleusPhase 1TOGANCT03386136
Therapeutic Oxygen for Gastrointestinal Atony (TOGA)
A Phase 1 study testing 100% Oxygen in people with Ileus and Ogilvie Syndrome, run by University of Florida at 1 site in United States.
Trial summary
This study is a non invasive study to see if 100% oxygen therapy will help to resolve an intestinal obstruction. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ileus, Ogilvie Syndrome, Small Bowel Obstruction
- What is being tested?
- 100% Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2018to 17 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- 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.
Show all 10Show fewer
- 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%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Ileus, Ogilvie Syndrome, Small Bowel Obstruction
- Being tested
- 100% Oxygen
- Keywords
- bowel ischemia, bowel perforation
- Medical subject headings
- Ileus, Colonic Pseudo-Obstruction, Intestinal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% OxygenDrug
To provide hospitalized ileus or pseudo-obstruction patient with 100% oxygen via non-rebreather face mask, for 6 hours
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: 100% Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 - 24 hours
Secondary outcomes (7)
Demonstrates No Resolution of Ileus
A second treatment with TOGA will be offered.
Measured: 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.
Measured: 24 - 30 hours after initial TOGA
Need for endoscopic or surgical intervention
Worsening of ileus after initial treatment, requiring surgical or endoscopic intervention
Measured: 24 - 30 hours after initial TOGA
Length of Hospital Stay
Length of stay, measured at the end of hospitalization
Measured: up to 100 weeks
Patient Complaints
Recording of patient perception/tolerance [daily] of TOGA.
Measured: 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.
Measured: 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)
Measured: 24 hours before through 24 hours after TOGA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start25 Jan 2018
- Primary completion17 Oct 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IleusStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian C. Weiner, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386136
- Sponsor's protocol ID
- IRB201701709
- Acronym
- TOGA
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 2017
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 39131150
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Oxygen for Gastrointestinal Atony (TOGA): Pilot Trial - Management of Acute Colonic Pseudo-Obstruction With Oxygen Supplementation
- ClinicalTrials.gov ID
- NCT03386136
- Acronym / sponsor ID
- TOGA / IRB201701709
- Conditions
- Ileus, Ogilvie Syndrome, Small Bowel Obstruction
- Keywords
- bowel ischemia, bowel perforation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a non invasive study to see if 100% oxygen therapy will help to resolve an intestinal obstruction.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Ileus or Pseudo-Obstruction Patient | Experimental | Drug: 100% OxygenHospitalized 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 100% OxygenTo provide hospitalized ileus or pseudo-obstruction patient with 100% oxygen via non-rebreather face mask, for 6 hours | Drug | Hospitalized Ileus or Pseudo-Obstruction Patient |
Primary outcome
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.
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.
7 secondary outcomes
Demonstrates No Resolution of Ileus
Time frame: 24 - 30 hours after initial TOGA
Worsening of Ileus
Time frame: 24 - 30 hours after initial TOGA
Need for endoscopic or surgical intervention
Time frame: 24 - 30 hours after initial TOGA
Length of Hospital Stay
Time frame: up to 100 weeks
Patient Complaints
Time frame: Up to 48 hours
Patient Pain Measurement
Time frame: Up to 48 hours
Medication Measurement
Time frame: 24 hours before through 24 hours after TOGA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Derived from this study: PubMed 39131150Weiner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian C. Weiner, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 100% Oxygen in people with Ileus and Ogilvie Syndrome, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Diameter of Colon (time frame: 6 - 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03386136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.