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

Not Applicable

Completed

• Conditions: Esophageal Atresia With Tracheo-esophageal Fistula; Congenital Diaphragmatic Hernia
• Interventions: Procedure: Hypercapnia during thoracoscopy; Procedure: Open surgery

• Registration Number: NCT01467245
• Lead Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

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 Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2011-02
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-08
• Study Completion: 2013-08
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypercapnia during thoracoscopy	Hypercapnia during thoracoscopy	keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
Open surgery	Open surgery	open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates

Primary Outcome Measures

Name	Time	Method
Arterial blood carbon dioxide measurement	Intra-operative	Arterial blood carbon dioxide will be measured during operation as standard of practice by obtaining the blood samples

Secondary Outcome Measures

Name	Time	Method
oxygenation of the brain	Intra-operative and 24 hours post-operatively	oxygenation of the brain will be measured by a non-invasive technique, near infra-red spectroscopy

Trial Locations

Locations (1)

Great Ormond Street Hospital for Children NHS Trust; 🇬🇧 London, United Kingdom