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

NCT02033772 — Completed, 17 participants, Arlyne Thung
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RegistryNCT02033772
StatusCompleted
Study typeObservational
Enrollment17 (Actual)
SponsorArlyne Thung (Other)
ConditionsCongenital Diaphragmatic Hernia, Tracheoesophageal Fistula, Esophageal Atresia
InterventionsThoracoscopic surgery (Procedure)
Datesstart 2013-08-01, primary completion 2017-10-06, completion 2017-10-06, first posted 2014-01-13, last updated 2018-01-12
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Congenital Diaphragmatic Hernia All trials for Tracheoesophageal Fistula All trials of Thoracoscopic surgery

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Thoracoscopic surgeryProcedure: Thoracoscopic surgeryInfants undergoing thoracoscopic surgery.
  • Thoracoscopic surgery (Procedure)

+Outcome measures

Primary outcomes

  • Change in transcutaneous CO2 [Duration of surgery, average of 3 hours.]

Secondary outcomes

  • 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.

+Eligibility

Sex: All, ages: any to 6 Months

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

+Locations (1)

FacilityCityCountryStatus
Nationwide Children's HospitalColumbus, OhioUnited States