Esophageal Atresia With Tracheo-esophageal FistulaCO2NCT01467245
Open or Keyhole Surgery Through the Chest for Newborn Babies: Effect on Blood Gases
A study testing Hypercapnia during thoracoscopy and Open surgery in people with Esophageal Atresia With Tracheo-esophageal Fistula and Congenital Diaphragmatic Hernia, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Esophageal Atresia With Tracheo-esophageal Fistula, Congenital Diaphragmatic Hernia
- What is being tested?
- Hypercapnia during thoracoscopy and Open surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Late diagnosis (after 1 month of age)
- Major congenital heart defects or pulmonary hypertension
- Bilateral grade IV intraventricular haemorrhage
- Previous ECMO
- FiO2 ≥ 0.4
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Great Ormond Street Hospital for Children NHS Trust
London, WC1N 3JH
About this study
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
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.
- Being tested
- Hypercapnia during thoracoscopy, Open surgery
- Keywords
- Thoracoscopy, congenital diaphragmatic hernia, oesophageal atresia, hypercapnia, acidosis, cerebral oxygenation, neonates
- Medical subject headings
- Esophageal atresia with or without tracheoesophageal fistula, Hernias, Diaphragmatic, Congenital, Esophageal Atresia, Hypercapnia, Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypercapnia during thoracoscopyProcedure or surgery
keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
Open surgeryProcedure or surgery
open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
| Study group | Role | What they receive |
|---|---|---|
| Hypercapnia during thoracoscopy | Experimental | keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates Receives: Procedure: Hypercapnia during thoracoscopy |
| Open surgery | Experimental | open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates Receives: Procedure: Open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood carbon dioxide measurement
Arterial blood carbon dioxide will be measured during operation as standard of practice by obtaining the blood samples
Measured: Intra-operative
Secondary outcomes (1)
oxygenation of the brain
oxygenation of the brain will be measured by a non-invasive technique, near infra-red spectroscopy
Measured: Intra-operative and 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startAug 2009
- Primary completionFeb 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Esophageal Atresia With Tracheo-esophageal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agostino Pierro, Prof, Principal investigator, Great Ormond Street Hospital for Children NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467245
- Sponsor's protocol ID
- 09SG04
- Acronym
- CO2
- Status last verified
- Feb 2022
- First submitted
- 4 Nov 2011
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16150335Holcomb 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.
PubMed 16135928Krosnar 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.
PubMed 15960636Bishay 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.
PubMed 23604057
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01467245
- Acronym / sponsor ID
- CO2 / 09SG04
- Keywords
- Thoracoscopy, congenital diaphragmatic hernia, oesophageal atresia, hypercapnia, acidosis, cerebral oxygenation, neonates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2009 (actual)
- Primary completion
- Feb 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypercapnia during thoracoscopy | Experimental | Procedure: Hypercapnia during thoracoscopykeyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates |
| Open surgery | Experimental | Procedure: Open surgeryopen surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Late diagnosis (after 1 month of age)
- Major congenital heart defects or pulmonary hypertension
- Bilateral grade IV intraventricular haemorrhage
- Previous ECMO
- FiO2 ≥ 0.4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypercapnia during thoracoscopykeyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates | Procedure or surgery | Hypercapnia during thoracoscopy |
| Open surgeryopen surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates | Procedure or surgery | Open surgery |
Primary outcome
Arterial blood carbon dioxide measurement
Time frame: Intra-operative
Arterial blood carbon dioxide will be measured during operation as standard of practice by obtaining the blood samples
1 secondary outcome
oxygenation of the brain
Time frame: Intra-operative and 24 hours post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Background: PubMed 16150335Yang 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.
- Background: PubMed 16135928Holcomb 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.
- Background: PubMed 15960636Krosnar 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 publication: PubMed 23604057Bishay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agostino Pierro, Prof principal investigator
Great Ormond Street Hospital for Children NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypercapnia during thoracoscopy and Open surgery in people with Esophageal Atresia With Tracheo-esophageal Fistula and Congenital Diaphragmatic Hernia, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial blood carbon dioxide measurement (time frame: Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01467245, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.