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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

Tracking Information
First Submitted Date November 22, 2013
First Posted Date January 13, 2014
Last Update Posted Date January 12, 2018
Study Start Date August 2013
Actual Primary Completion Date October 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2014)
Change in transcutaneous CO2 [ Time Frame: Duration of surgery, average of 3 hours. ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02033772 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 9, 2014)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Data Collection of Patients < 6 Months of Age Undergoing Thoracoscopic Surgery
Official Title Not Provided
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Infants < 6 months of age undergoing thoracoscopic surgery.
Condition
  • Congenital Diaphragmatic Hernia
  • Tracheoesophageal Fistula
  • Esophageal Atresia
Intervention Procedure: Thoracoscopic surgery
Study Groups/Cohorts Thoracoscopic surgery
Infants undergoing thoracoscopic surgery.
Intervention: Procedure: Thoracoscopic surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 11, 2018)
17
Original Estimated Enrollment
 (submitted: January 9, 2014)
20
Actual Study Completion Date October 6, 2017
Actual Primary Completion Date October 6, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 6 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02033772
Other Study ID Numbers IRB12-00503
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Arlyne Thung, Nationwide Children's Hospital
Study Sponsor Arlyne Thung
Collaborators Not Provided
Investigators Not Provided
PRS Account Nationwide Children's Hospital
Verification Date January 2018