Clinical trial NCT01467245: Open or Keyhole Surgery Through the Chest for Newborn Babies: Effect on Blood Gases
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Atresia With Tracheo-esophageal Fistula
Congenital Diaphragmatic Hernia
Keywords: Thoracoscopy
congenital diaphragmatic hernia
oesophageal atresia
hypercapnia
acidosis
cerebral oxygenation
neonates
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 20
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Arterial blood carbon dioxide measurement
timeFrame: Intra-operative
Secondary outcomes:
measure: oxygenation of the brain
timeFrame: Intra-operative and 24 hours post-operatively
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS Trust
Study officials:
affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust
name: Agostino Pierro, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.jpedsurg.2005.05.036.
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. doi: 10.1097/01.sla.0000179649.15576.db.
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. doi: 10.1111/j.1460-9592.2005.01594.x.
citation: 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.