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

Congenital Diaphragmatic Hernia Clinical Trial

— CO2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467245
• Other study ID #: 09SG04
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: August 2013

Study information

• Verified date: February 2022
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Congenital Diaphragmatic Hernia
• Esophageal Atresia
• Esophageal Atresia With Tracheo-esophageal Fistula
• Esophageal Fistula
• Fistula
• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital
• Tracheoesophageal Fistula

Intervention

Procedure:
• 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 for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital for Children NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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 e — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial blood carbon dioxide measurement	Arterial blood carbon dioxide will be measured during operation as standard of practice by obtaining the blood samples	Intra-operative
Secondary	oxygenation of the brain	oxygenation of the brain will be measured by a non-invasive technique, near infra-red spectroscopy	Intra-operative and 24 hours post-operatively