Therapeutic Oxygen for Gastrointestinal Atony (TOGA): Pilot Trial - Management of Acute Colonic Pseudo-Obstruction With Oxygen Supplementation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Changes in Diameter of Colon
研究概览
简要总结
This study is a non invasive study to see if 100% oxygen therapy will help to resolve an intestinal obstruction.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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]
排除标准
- •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%.
研究组 & 干预措施
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
干预措施: 100% Oxygen (Drug)
结局指标
主要结局
Changes in Diameter of Colon
时间窗: 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
时间窗: 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.
次要结局
- Patient Complaints(Up to 48 hours)
- Demonstrates No Resolution of Ileus(24 - 30 hours after initial TOGA)
- Worsening of Ileus(24 - 30 hours after initial TOGA)
- Need for endoscopic or surgical intervention(24 - 30 hours after initial TOGA)
- Length of Hospital Stay(up to 100 weeks)
- Patient Pain Measurement(Up to 48 hours)
- Medication Measurement(24 hours before through 24 hours after TOGA)