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

Completed

• Conditions: Tracheoesophageal Fistula; Esophageal Atresia; Congenital Diaphragmatic Hernia
• Interventions: Procedure: Thoracoscopic surgery

• Registration Number: NCT02033772
• Lead Sponsor: Arlyne Thung

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Primary Completion: 2017-10-06
• Study Completion: 2017-10-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thoracoscopic surgery	Thoracoscopic surgery	Infants undergoing thoracoscopic surgery.

Primary Outcome Measures

Name	Time	Method
Change in transcutaneous CO2	Duration of surgery, average of 3 hours.

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure	Duration of surgery, average of 3 hours.	Non-invasive and invasive.
Change in ET-CO2	Duration of surgery, average of 3 hours.	End-tidal CO2
Change in SpO2	Duration of surgery, average of 3 hours.	Oxygen saturation.
Change in heart rate	Duration of surgery, average of 3 hours.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States