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

NCT01467245 | Completed DMC

• 1 other identifier: 09SG04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Atresia With Tracheo-esophageal Fistula; Congenital Diaphragmatic Hernia

Keywords

Thoracoscopy; congenital diaphragmatic hernia; oesophageal atresia; hypercapnia; acidosis; cerebral oxygenation; neonates

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• oxygenation of the brain

  Intra-operative and 24 hours post-operatively

Study Arms (2)

Hypercapnia during thoracoscopy

EXPERIMENTAL

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

Procedure: Hypercapnia during thoracoscopy

Open surgery

EXPERIMENTAL

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

Procedure: Open surgery

Interventions

Hypercapnia during thoracoscopy PROCEDURE

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

Hypercapnia during thoracoscopy

Open surgery PROCEDURE

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

Open surgery

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Late diagnosis (after 1 month of age)
• Major congenital heart defects or pulmonary hypertension
• Bilateral grade IV intraventricular haemorrhage
• Previous ECMO
• FiO2 ≥ 0.4

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital for Children NHS Trust

London, WC1N 3JH, United Kingdom

Location

Related Publications (4)

• 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. doi: 10.1016/j.jpedsurg.2005.05.036.

  PMID: 16150335 BACKGROUND

• 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. doi: 10.1097/01.sla.0000179649.15576.db.

  PMID: 16135928 BACKGROUND

• 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. doi: 10.1111/j.1460-9592.2005.01594.x.

  PMID: 15960636 BACKGROUND

• 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 esophageal atresia: results of a pilot randomized controlled trial. Ann Surg. 2013 Dec;258(6):895-900. doi: 10.1097/SLA.0b013e31828fab55.

  PMID: 23604057 RESULT

MeSH Terms

Conditions

Esophageal atresia with or without tracheoesophageal fistula; Hernias, Diaphragmatic, Congenital; Esophageal Atresia; Hypercapnia; Acidosis

Interventions

Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Agostino Pierro, Prof

  Great Ormond Street Hospital for Children NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: November 8, 2011
• Study Start: August 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: August 1, 2013
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

GB (1)