University of Florida
Gainesville, Florida, 32610, United States
NCT Number: NCT03386136
This study is a non invasive study to see if 100% oxygen therapy will help to resolve an intestinal obstruction.
Looking for future studies?
Notify Me18 year–100 year
All sexes
Interventional
Phase 1
Gainesville, Florida, 32610, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To provide hospitalized ileus or pseudo-obstruction patient with 100% oxygen via non-rebreather face mask, for 6 hours
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.
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.
Time frame: 24 - 30 hours after initial TOGA
A second treatment with TOGA will be offered.
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.
Time frame: 24 - 30 hours after initial TOGA
Worsening of ileus after initial treatment, requiring surgical or endoscopic intervention
Time frame: up to 100 weeks
Length of stay, measured at the end of hospitalization
Time frame: Up to 48 hours
Recording of patient perception/tolerance [daily] of TOGA.
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.
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)
University of Florida
Other
Therapeutic Oxygen for Gastrointestinal Atony (TOGA): Pilot Trial - Management of Acute Colonic Pseudo-Obstruction With Oxygen Supplementation
Acronym: TOGA
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.
Published trials that share one or more normalized conditions with this study.
NCT06815822
Appendicitis, Appendicitis Acute
Kielce, Poland
View Trial DetailsNCT07248098
Digestive System Diseases, Gastrointestinal Diseases
Adana, Saricam, Turkey (Türkiye)
View Trial DetailsNCT05985343
Digestive System Diseases, Gastrointestinal Diseases
Cleveland, Ohio, United States
View Trial DetailsNCT04405037
Digestive System Diseases, Gastrointestinal Diseases
Cleveland, Ohio, United States
View Trial Details