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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01467245

Acronym

CO2

Enrollment

Registered

2011-11-08

Start date

2009-08-31

Completion date

2013-08-31

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Diaphragmatic Hernia, Esophageal Atresia With Tracheo-esophageal Fistula

Keywords

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

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.

Interventions

PROCEDUREHypercapnia during thoracoscopy

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

PROCEDUREOpen surgery

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026