Therapeutic Oxygen for Gastrointestinal Atony (TOGA)

• Status: Completed
• Trial end date: 2019-10-17
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida

Criteria

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%.