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NCT02033772 Clinical Trial

Prospective Data Collection of Patients < 6 Months of Age Undergoing Thoracoscopic Surgery

Congenital Diaphragmatic Hernia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02033772
Other study ID # IRB12-00503
Secondary ID
Status Completed
Phase N/A
First received November 22, 2013
Last updated January 11, 2018
Start date August 2013
Est. completion date October 6, 2017

Study information
Verified date January 2018
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 (HFOV) and thoracoscopic procedures.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date October 6, 2017
Est. primary completion date October 6, 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Months
Eligibility Inclusion Criteria:

- Patients presenting for thoracoscopic surgery

- Patients aged = 6 months of age

Exclusion Criteria:

- Patients presenting for any procedure other than thoracoscopic surgery

- Patients aged > 6 months of age

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Thoracoscopic surgery

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Arlyne Thung

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in transcutaneous CO2 Duration of surgery, average of 3 hours.
Secondary Change in ET-CO2 End-tidal CO2 Duration of surgery, average of 3 hours.
Secondary Change in heart rate Duration of surgery, average of 3 hours.
Secondary Change in blood pressure Non-invasive and invasive. Duration of surgery, average of 3 hours.
Secondary Change in SpO2 Oxygen saturation. Duration of surgery, average of 3 hours.
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