Trial record 3 of 3 for:    "esophageal atresia tracheoesophageal fistula" OR "Esophageal Atresia"

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Arlyne Thung, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT02033772
First received: November 22, 2013
Last updated: January 9, 2014
Last verified: January 2014
  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 Nationwide Children's Hospital:

Primary Outcome Measures:
  • Change in transcutaneous CO2 [ Time Frame: Duration of surgery, average of 3 hours. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in ET-CO2 [ Time Frame: Duration of surgery, average of 3 hours. ] [ Designated as safety issue: No ]
    End-tidal CO2

  • Change in heart rate [ Time Frame: Duration of surgery, average of 3 hours. ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: Duration of surgery, average of 3 hours. ] [ Designated as safety issue: No ]
    Non-invasive and invasive.

  • Change in SpO2 [ Time Frame: Duration of surgery, average of 3 hours. ] [ Designated as safety issue: No ]
    Oxygen saturation.


Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Thoracoscopic surgery
Infants undergoing thoracoscopic surgery.
Procedure: Thoracoscopic surgery

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02033772

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

No publications provided

Responsible Party: Arlyne Thung, Assistant Clinical Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02033772     History of Changes
Other Study ID Numbers: IRB12-00503
Study First Received: November 22, 2013
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 20, 2014