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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02033772

Enrollment

Registered

2014-01-13

Start date

2013-08-31

Completion date

2017-10-06

Last updated

2018-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Diaphragmatic Hernia, Esophageal Atresia, Tracheoesophageal Fistula

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.

Interventions

PROCEDUREThoracoscopic surgery

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in transcutaneous CO2	Duration of surgery, average of 3 hours.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026