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

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Keywords

Abstract

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.

Dates

Last Verified:	05/31/2012
First Submitted:	11/03/2011
Estimated Enrollment Submitted:	11/06/2011
First Posted:	11/07/2011
Last Update Submitted:	06/07/2012
Last Update Posted:	06/10/2012
Actual Study Start Date:	07/31/2009
Estimated Primary Completion Date:	07/31/2013
Estimated Study Completion Date:	07/31/2013

Condition or disease

Esophageal Atresia With Tracheo-esophageal Fistula

Congenital Diaphragmatic Hernia

Intervention/treatment

Procedure: Hypercapnia during thoracoscopy

Procedure: Open surgery

Phase

Arm Groups

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

Eligibility Criteria

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

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

Outcome

Primary Outcome Measures

1. Arterial blood carbon dioxide measurement [undefined]

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 [undefined]

oxygenation of the brain will be measured by a non-invasive technique, near infra-red spectroscopy

2. arterial carbon dioxide levels measured transcutaneously [undefined]

arterial carbon dioxide levels measured transcutaneously by non-invasively using a probe placed on the skin

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

Keywords

hypercapnia

fistula

hernia

esophageal atresia

dental caries

acidosis