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OpenTrials
Completed

NCT Number: NCT02033772

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

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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Key information

Conditions

Congenital Diaphragmatic Hernia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Digestive System Fistula Esophageal Atresia Esophageal Diseases Esophageal Fistula Fistula Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Hernias, Diaphragmatic, Congenital Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Fistula Tracheal Diseases Tracheoesophageal Fistula

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoracoscopic Surgery

Procedure

Primary outcomes

  1. Change in transcutaneous CO2

    Time frame: Duration of surgery, average of 3 hours.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Arlyne Thung

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 13, 2014
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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