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
|Condition or disease||Intervention/treatment||Phase|
|Ileus Ogilvie Syndrome Small Bowel Obstruction||Drug: 100% Oxygen||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- Demonstrates No Resolution of Ileus [ Time Frame: 24 - 30 hours after initial TOGA ]A second treatment with TOGA will be offered.
- 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.
- 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
- Length of Hospital Stay [ Time Frame: up to 100 weeks ]Length of stay, measured at the end of hospitalization
- Patient Complaints [ Time Frame: Up to 48 hours ]Recording of patient perception/tolerance [daily] of TOGA.
- 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.
- 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)
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
|Contact: April Goddard, PAfirstname.lastname@example.org|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Brian C. Weiner, MD||University of Florida|