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

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ClinicalTrials.gov Identifier: NCT02033772
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Arlyne Thung, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment
Congenital Diaphragmatic Hernia Tracheoesophageal Fistula Esophageal Atresia Procedure: Thoracoscopic surgery

Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : August 2013
Primary Completion Date : October 6, 2017
Study Completion Date : October 6, 2017


Group/Cohort Intervention/treatment
Thoracoscopic surgery
Infants undergoing thoracoscopic surgery.
Procedure: Thoracoscopic surgery



Primary Outcome Measures :
  1. Change in transcutaneous CO2 [ Time Frame: Duration of surgery, average of 3 hours. ]

Secondary Outcome Measures :
  1. Change in ET-CO2 [ Time Frame: Duration of surgery, average of 3 hours. ]
    End-tidal CO2

  2. Change in heart rate [ Time Frame: Duration of surgery, average of 3 hours. ]
  3. Change in blood pressure [ Time Frame: Duration of surgery, average of 3 hours. ]
    Non-invasive and invasive.

  4. Change in SpO2 [ Time Frame: Duration of surgery, average of 3 hours. ]
    Oxygen saturation.



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants < 6 months of age undergoing thoracoscopic surgery.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033772


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Arlyne Thung

Responsible Party: Arlyne Thung, Assistant Clinical Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02033772     History of Changes
Other Study ID Numbers: IRB12-00503
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Fistula
Hernia, Diaphragmatic
Hernias, Diaphragmatic, Congenital
Esophageal Atresia
Tracheoesophageal Fistula
Pathological Conditions, Anatomical
Hernia
Congenital Abnormalities
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Esophageal Fistula
Digestive System Fistula
Respiratory Tract Fistula
Respiratory Tract Diseases
Tracheal Diseases