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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 6, 2017

Interventions

  • Procedure: Thoracoscopic surgery

Arms, Groups and Cohorts

  • Thoracoscopic surgery
    • Infants undergoing thoracoscopic surgery.

Clinical Trial Outcome Measures

Primary Measures

  • Change in transcutaneous CO2
    • Time Frame: Duration of surgery, average of 3 hours.

Secondary Measures

  • Change in ET-CO2
    • Time Frame: Duration of surgery, average of 3 hours.
    • End-tidal CO2
  • 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.
    • Non-invasive and invasive.
  • Change in SpO2
    • Time Frame: Duration of surgery, average of 3 hours.
    • Oxygen saturation.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 6 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Arlyne Thung
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Arlyne Thung, Assistant Clinical Professor – Nationwide Children’s Hospital

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