Therapeutic Oxygen for Gastrointestinal Atony (TOGA)

Ileus Clinical Trial

— TOGA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386136
• Other study ID #: IRB201701709
• Status: Completed
• Phase: Phase 1
• Start date: January 25, 2018
• Est. completion date: October 17, 2019

Study information

• Verified date: December 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 17, 2019
• Est. primary completion date: October 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Colonic Pseudo-Obstruction
• Ileus
• Intestinal Obstruction
• Ogilvie Syndrome
• Small Bowel Obstruction

Intervention

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

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Demonstrates No Resolution of Ileus	A second treatment with TOGA will be offered.	24 - 30 hours after initial TOGA
Secondary	Worsening of Ileus	Worsening of ileus after initial treatment but not requiring surgical or endoscopic intervention, will be offered a second treatment of TOGA.	24 - 30 hours after initial TOGA
Secondary	Need for endoscopic or surgical intervention	Worsening of ileus after initial treatment, requiring surgical or endoscopic intervention	24 - 30 hours after initial TOGA
Secondary	Length of Hospital Stay	Length of stay, measured at the end of hospitalization	up to 100 weeks
Secondary	Patient Complaints	Recording of patient perception/tolerance [daily] of TOGA.	Up to 48 hours
Secondary	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.	Up to 48 hours
Secondary	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)	24 hours before through 24 hours after TOGA