search
Back to results

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

Primary Purpose

Esophageal Atresia With Tracheo-esophageal Fistula, Congenital Diaphragmatic Hernia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hypercapnia during thoracoscopy
Open surgery
Sponsored by
Great Ormond Street Hospital for Children NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Atresia With Tracheo-esophageal Fistula focused on measuring Thoracoscopy, congenital diaphragmatic hernia, oesophageal atresia, hypercapnia, acidosis, cerebral oxygenation, neonates

Eligibility Criteria

undefined - 1 Month (Child)All SexesDoes not accept 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

Sites / Locations

  • Great Ormond Street Hospital for Children NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hypercapnia during thoracoscopy

Open surgery

Arm Description

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

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

Outcomes

Primary Outcome Measures

Arterial blood carbon dioxide measurement
Arterial blood carbon dioxide will be measured during operation as standard of practice by obtaining the blood samples

Secondary Outcome Measures

oxygenation of the brain
oxygenation of the brain will be measured by a non-invasive technique, near infra-red spectroscopy

Full Information

First Posted
November 4, 2011
Last Updated
February 11, 2022
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT01467245
Brief Title
Open or Keyhole Surgery Through the Chest for Newborn Babies: Effect on Blood Gases
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 2009 (Actual)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Atresia With Tracheo-esophageal Fistula, Congenital Diaphragmatic Hernia
Keywords
Thoracoscopy, congenital diaphragmatic hernia, oesophageal atresia, hypercapnia, acidosis, cerebral oxygenation, neonates

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypercapnia during thoracoscopy
Arm Type
Experimental
Arm Description
keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
Arm Title
Open surgery
Arm Type
Experimental
Arm Description
open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
Intervention Type
Procedure
Intervention Name(s)
Hypercapnia during thoracoscopy
Intervention Description
keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
Intervention Type
Procedure
Intervention Name(s)
Open surgery
Intervention Description
open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
Primary Outcome Measure Information:
Title
Arterial blood carbon dioxide measurement
Description
Arterial blood carbon dioxide will be measured during operation as standard of practice by obtaining the blood samples
Time Frame
Intra-operative
Secondary Outcome Measure Information:
Title
oxygenation of the brain
Description
oxygenation of the brain will be measured by a non-invasive technique, near infra-red spectroscopy
Time Frame
Intra-operative and 24 hours post-operatively

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agostino Pierro, Prof
Organizational Affiliation
Great Ormond Street Hospital for Children NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Great Ormond Street Hospital for Children NHS Trust
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
16150335
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.
Results Reference
background
PubMed Identifier
16135928
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.
Results Reference
background
PubMed Identifier
15960636
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.
Results Reference
background
PubMed Identifier
23604057
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs