Open or Keyhole Surgery Through the Chest for Newborn Babies: Effect on Blood Gases (The CO2)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Esophageal Atresia With Tracheo-esophageal Fistula; Congenital Diaphragmatic Hernia	Procedure: Hypercapnia during thoracoscopy; Procedure: Open surgery	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Hypercapnia During Thoracoscopy or Open Surgery for Repair of Oesophageal Atresia With Tracheo-oesophageal Fistula or Congenital Diaphragmatic Hernia in Neonates: Pilot Randomised Controlled Trial
Study Start Date :	August 2009
Estimated Primary Completion Date :	August 2013
Estimated Study Completion Date :	August 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Hypercapnia during thoracoscopy; keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates	Procedure: Hypercapnia during thoracoscopy; keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
Experimental: Open surgery; open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates	Procedure: Open surgery; open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 1 Month (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Neonates with diagnosis of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia

  ->1.6 Kg

• Conventional ventilation (no high frequency ventilation or iNO) for at least 24 hours.
• FiO2 <0.4
• No requirement for inotropes for at least 24 hours

Exclusion Criteria:

• Late diagnosis (after 1 month of age)
• Major congenital heart defects or pulmonary hypertension
• Bilateral grade IV intraventricular haemorrhage
• Previous ECMO
• FiO2 ≥ 0.4

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Agostino Pierro, Prof	0044207 905 2641	a.pierro@ucl.ac.uk
Contact: Mark Bishay	0044207 905 2733	mark.bishay@ucl.ac.uk

Locations

United Kingdom
Great Ormond Street Hospital for Children NHS Trust	Recruiting
London, United Kingdom, WC1N 3JH
Contact: Agostino Pierro, Prof 0044207 905 2641 a.pierro@ucl.ac.uk
Contact: Mark Bishay 0044207 905 2733 mark.bishay@ucl.ac.uk
Principal Investigator: Agostino Pierro, Prof

Sponsors and Collaborators

Great Ormond Street Hospital for Children NHS Foundation Trust

Investigators

Principal Investigator:	Agostino Pierro, Prof	Great Ormond Street Hospital for Children NHS Foundation Trust

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Yang EY, Allmendinger N, Johnson SM, Chen C, Wilson JM, Fishman SJ. Neonatal thoracoscopic repair of congenital diaphragmatic hernia: selection criteria for successful outcome. J Pediatr Surg. 2005 Sep;40(9):1369-75.

Holcomb GW 3rd, Rothenberg SS, Bax KM, Martinez-Ferro M, Albanese CT, Ostlie DJ, van Der Zee DC, Yeung CK. Thoracoscopic repair of esophageal atresia and tracheoesophageal fistula: a multi-institutional analysis. Ann Surg. 2005 Sep;242(3):422-8; discussion 428-30.

Krosnar S, Baxter A. Thoracoscopic repair of esophageal atresia with tracheoesophageal fistula: anesthetic and intensive care management of a series of eight neonates. Paediatr Anaesth. 2005 Jul;15(7):541-6. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bishay M, Giacomello L, Retrosi G, Thyoka M, Garriboli M, Brierley J, Harding L, Scuplak S, Cross KM, Curry JI, Kiely EM, De Coppi P, Eaton S, Pierro A. Hypercapnia and acidosis during open and thoracoscopic repair of congenital diaphragmatic hernia and esophageal atresia: results of a pilot randomized controlled trial. Ann Surg. 2013 Dec;258(6):895-900. doi: 10.1097/SLA.0b013e31828fab55.

Responsible Party:	Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT01467245 History of Changes
Other Study ID Numbers:	09SG04
First Posted:	November 8, 2011
Last Update Posted:	June 11, 2012
Last Verified:	June 2012

Keywords provided by Great Ormond Street Hospital for Children NHS Foundation Trust:

Thoracoscopy; congenital diaphragmatic hernia; oesophageal atresia; hypercapnia	acidosis; cerebral oxygenation; neonates

Additional relevant MeSH terms:

Hernia; Fistula; Hernia, Diaphragmatic; Hernias, Diaphragmatic, Congenital; Esophageal Atresia; Esophageal Fistula; Tracheoesophageal Fistula; Pathological Conditions, Anatomical; Congenital Abnormalities	Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Fistula; Respiratory Tract Fistula; Respiratory Tract Diseases; Tracheal Diseases