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临床试验/ACTRN12621000918820
ACTRN12621000918820已完成4 期

Effects of a Familiarization Video & Patient–Controlled Entonox Inhalation on Patient Comfort & Clinical Efficacy of Elective Flexible Sigmoidoscopy; Assessment of the Feasibility & Acceptability of Combining these Two Treatments.

Philip Bagshaw0 个研究点目标入组 154 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
154

研究概览

简要总结

The study showed that a pre-procedure familiarization video did not make an examination of the lower bowel by an endoscope, without pain relief or sedation, any more pleasant. However, having Entonox gas to breathe during the procedure did improve the experience and made it possible to examine a longer length of bowel. Measuring changes in heart rate can help to see how stressed patients get during such an examination.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 50 Years(—)
性别
All

入选标准

  • Patients aged 18 to 50 years of age with outlet-type fresh rectal bleeding, referred from Canterbury District Health Board and Canterbury GPs because they do not reach the required threshold scores to qualify for lower GI endoscopy in the public hospital system.; Patients aged 18 to 50 years of age with outlet-type fresh rectal bleeding, referred from Canterbury District Health Board and Canterbury GPs because they do not reach the required threshold scores to qualify for lower GI endoscopy in the public hospital system.

排除标准

  • 1.Unwilling or unable to give informed consent.
  • 2.Significant medical co-morbidities (ASA 3 & 4).
  • 3.Acute asthma or advanced COPD (O2 Stats < 94%)
  • 4.History of pneumothorax.
  • 5.Decompression sickness or recent dive.
  • 6.Pulmonary hypertension.
  • 7.Severe bone marrow depression or similar haematological disorders
  • e.g. homocysteinaemia.
  • 8.During first trimester of pregnancy.
  • 9.Middle ear disease or surgery.
  • 10.Obstruction of sinus cavities
  • 11.Recent eye surgery or gas injections.
  • 12.Gross abdominal distension.
  • 13.Any anticoagulant and anti-platelet medication or known bleeding diathesis.
  • 14.Strong sedative or analgesic medication e.g. Benzodiazepines, opioids.
  • 15.Vitamin B12 deficiency
  • 16.Severe terminal disease or life expectance of less than 5 years.
  • ; 1.Unwilling or unable to give informed consent.
  • 2.Significant medical co-morbidities (ASA 3 & 4).
  • 3.Acute asthma or advanced COPD (O2 Stats < 94%)
  • 4.History of pneumothorax.
  • 5.Decompression sickness or recent dive.
  • 6.Pulmonary hypertension.
  • 7.Severe bone marrow depression or similar haematological disorders
  • e.g. homocysteinaemia.
  • 8.During first trimester of pregnancy.
  • 9.Middle ear disease or surgery.
  • 10.Obstruction of sinus cavities
  • 11.Recent eye surgery or gas injections.
  • 12.Gross abdominal distension.
  • 13.Any anticoagulant and anti-platelet medication or known bleeding diathesis.
  • 14.Strong sedative or analgesic medication e.g. Benzodiazepines, opioids.
  • 15.Vitamin B12 deficiency
  • 16.Severe terminal disease or life expectance of less than 5 years.

研究者

发起方
Philip Bagshaw

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