Clinical Trial: Open or Keyhole Surgery Through the Chest for Newborn Babies: Effect on Blood Gases

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Hypercapnia During Thoracoscopy or Open Surgery for Repair of Oesophageal Atresia With Tracheo-oesophageal Fistula or Congenital Diaphragmatic Hernia in Neonates: Pilot Ra

Brief Summary: This is a pilot randomised controlled trial comparing open versus thoracoscopic surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates. Thoracoscopic surgery involves insufflation of carbon dioxide into the thoracic cavity and may therefore cause hypercapnia and acidosis.

Detailed Summary:
Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

Current Primary Outcome: Arterial blood carbon dioxide measurement

Arterial blood carbon dioxide will be measured during operation as standard of practice by obtaining the blood samples


Original Primary Outcome: Arterial blood carbon dioxide and acid levels during operation

Arterial blood carbon dioxide and acid levels during operation


Current Secondary Outcome:

  • oxygenation of the brain
    oxygenation of the brain will be measured by a non-invasive technique, near infra-red spectroscopy
  • arterial carbon dioxide levels measured transcutaneously
    arterial carbon dioxide levels measured transcutaneously by non-invasively using a probe placed on the skin


Original Secondary Outcome:

  • oxygenation of the brain (measured by a non-invasive technique, near infra-red spectroscopy)
    oxygenation of the brain (measured by a non-invasive technique, near infra-red spectroscopy)
  • arterial carbon dioxide levels measured transcutaneously (non-invasively using a probe placed on the skin)
    arterial carbon dioxide levels measured transcutaneously (non-invasively using a probe placed on the skin)
  • the percentage of exhaled carbon dioxide that comes from the carbon dioxide used to inflate the chest. This will be accomplished non-invasively by taking breath samples from patients during the operation.
    the percentage of exhaled carbon dioxide that comes from the carbon dioxide used to inflate the chest. This will be accomplished non-invasively by taking breath samples from patients during the operation.


Information By: Great Ormond Street Hospital for Children NHS Foundation Trust

Dates:
Date Received: November 4, 2011
Date Started: August 2009
Date Completion: August 2013
Last Updated: June 8, 2012
Last Verified: June 2012