Congenital Diaphragmatic HerniaNCT02033772
Prospective Data Collection of Patients < 6 Months of Age Undergoing Thoracoscopic Surgery
An observational study of Congenital Diaphragmatic Hernia and Tracheoesophageal Fistula, run by Arlyne Thung at 1 site in United States.
Trial summary
The study is primarily a descriptive study examining the physiological, ventilatory, surgical, and recovery effects of patients ≤ 6 months of age who undergo thoracoscopic surgery and to determine the accuracy of transcutaneous CO2 (TC-CO2) and end-tidal CO2 (ET-CO2) during high frequency oscillatory ventilation… Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Congenital Diaphragmatic Hernia, Tracheoesophageal Fistula, Esophageal Atresia
- What is being tested?
- Thoracoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 6 Oct 2017
- Phase
- Observational
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants < 6 months of age undergoing thoracoscopic surgery.
Who may be able to join
- Patients presenting for thoracoscopic surgery
- Patients aged ≤ 6 months of age
Who cannot join
- Patients presenting for any procedure other than thoracoscopic surgery
- Patients aged > 6 months of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
The study is primarily a descriptive study examining the physiological, ventilatory, surgical, and recovery effects of patients ≤ 6 months of age who undergo thoracoscopic surgery and to determine the accuracy of transcutaneous CO2 (TC-CO2) and end-tidal CO2 (ET-CO2) during high frequency oscillatory ventilation (HFOV) and thoracoscopic procedures.
- Being tested
- Thoracoscopic surgery
- Medical subject headings
- Hernias, Diaphragmatic, Congenital, Tracheoesophageal Fistula, Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoscopic surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Thoracoscopic surgery | Infants undergoing thoracoscopic surgery. Receives: Procedure: Thoracoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transcutaneous CO2
Measured: Duration of surgery, average of 3 hours.
Secondary outcomes (4)
Change in ET-CO2
End-tidal CO2
Measured: Duration of surgery, average of 3 hours.
Change in heart rate
Measured: Duration of surgery, average of 3 hours.
Change in blood pressure
Non-invasive and invasive.
Measured: Duration of surgery, average of 3 hours.
Change in SpO2
Oxygen saturation.
Measured: Duration of surgery, average of 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startAug 2013
- Primary completion6 Oct 2017
- Study completion6 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Diaphragmatic HerniaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arlyne Thung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arlyne Thung, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033772
- Sponsor's protocol ID
- IRB12-00503
- Status last verified
- Jan 2018
- First submitted
- 22 Nov 2013
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Data Collection of Patients < 6 Months of Age Undergoing Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT02033772
- Acronym / sponsor ID
- IRB12-00503
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Arlyne ThungUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- 6 Oct 2017 (actual)
- Study completion
- 6 Oct 2017 (actual)
- First posted
- 13 Jan 2014 (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.
The study is primarily a descriptive study examining the physiological, ventilatory, surgical, and recovery effects of patients ≤ 6 months of age who undergo thoracoscopic surgery and to determine the accuracy of transcutaneous CO2 (TC-CO2) and end-tidal CO2 (ET-CO2) during high frequency oscillatory ventilation (HFOV) and thoracoscopic procedures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopic surgery | – | Procedure: Thoracoscopic surgeryInfants undergoing thoracoscopic surgery. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants < 6 months of age undergoing thoracoscopic surgery.
Key inclusion criteria (2 listed)
- Patients presenting for thoracoscopic surgery
- Patients aged ≤ 6 months of age
Key exclusion criteria (2 listed)
- Patients presenting for any procedure other than thoracoscopic surgery
- Patients aged > 6 months of age
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 |
|---|---|---|
| Thoracoscopic surgery | Procedure or surgery | Thoracoscopic surgery |
Primary outcome
Change in transcutaneous CO2
Time frame: Duration of surgery, average of 3 hours.
4 secondary outcomes
Change in ET-CO2
Time frame: Duration of surgery, average of 3 hours.
Change in heart rate
Time frame: Duration of surgery, average of 3 hours.
Change in blood pressure
Time frame: Duration of surgery, average of 3 hours.
Change in SpO2
Time frame: Duration of surgery, average of 3 hours.
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 12 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Diaphragmatic Hernia and Tracheoesophageal Fistula, run by Arlyne Thung at 1 site in United States.
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 2 inclusion and 2 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 12 Jan 2018. 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 States. 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?
Change in transcutaneous CO2 (time frame: Duration of surgery, average of 3 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2018.