We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02033772
First Posted: January 13, 2014
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Arlyne Thung, Nationwide Children's Hospital
  Purpose
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 Intervention
Congenital Diaphragmatic Hernia Tracheoesophageal Fistula Esophageal Atresia Procedure: Thoracoscopic surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Arlyne Thung, Nationwide Children's Hospital:

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

Secondary Outcome 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.


Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Thoracoscopic surgery
Infants undergoing thoracoscopic surgery.
Procedure: Thoracoscopic surgery

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: November 22, 2013
First Posted: January 13, 2014
Last Update Posted: February 23, 2017
Last Verified: February 2017

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