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

• Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT01467245
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 48
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel 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
• Actual Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

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

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 1 Month
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Great Ormond Street Hospital for Children NHS Trust	London		United Kingdom	WC1N 3JH

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT01467245
• Other Study ID Numbers: 09SG04
• First Posted: Nov 8, 2011
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• 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: Esophageal Atresia; Esophageal Fistula; Tracheoesophageal Fistula; Hernias, Diaphragmatic, Congenital; Hernia; Fistula; Hernia, Diaphragmatic

Study Results

No Results Posted as of Mar 2, 2022