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

NHS Foundation Trust

Status: Completed

Conditions: Esophageal Atresia With Tracheo-esophageal Fistula; Congenital Diaphragmatic Hernia

Treatments: Procedure: Open surgery; Procedure: Hypercapnia during thoracoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01467245

09SG04

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: Under 1 month old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Hypercapnia during thoracoscopy

Experimental group

Description:

keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates

Treatment:

Procedure: Hypercapnia during thoracoscopy

Open surgery

Experimental group

Description:

open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates

Treatment:

Procedure: Open surgery