Therapeutic Oxygen for Gastrointestinal Atony (TOGA)

Phase 1

Completed

Brief Summary: 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

Recruitment & 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%.

Arm && Interventions

Group	Intervention	Description
Hospitalized Ileus or Pseudo-Obstruction Patient	100% Oxygen	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

Primary Outcome Measures

Name	Time	Method
Changes in Diameter of Colon	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	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.

Secondary Outcome Measures

Name	Time	Method
Demonstrates No Resolution of Ileus	24 - 30 hours after initial TOGA	A second treatment with TOGA will be offered.
Worsening of Ileus	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	24 - 30 hours after initial TOGA	Worsening of ileus after initial treatment, requiring surgical or endoscopic intervention
Length of Hospital Stay	up to 100 weeks	Length of stay, measured at the end of hospitalization
Patient Complaints	Up to 48 hours	Recording of patient perception/tolerance \[daily\] of TOGA.
Patient Pain Measurement	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	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)

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