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

January 11, 2018 updated by: Arlyne Thung
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants < 6 months of age undergoing thoracoscopic surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in transcutaneous CO2
Time Frame: Duration of surgery, average of 3 hours.
Duration of surgery, average of 3 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ET-CO2
Time Frame: Duration of surgery, average of 3 hours.
End-tidal CO2
Duration of surgery, average of 3 hours.
Change in heart rate
Time Frame: Duration of surgery, average of 3 hours.
Duration of surgery, average of 3 hours.
Change in blood pressure
Time Frame: Duration of surgery, average of 3 hours.
Non-invasive and invasive.
Duration of surgery, average of 3 hours.
Change in SpO2
Time Frame: Duration of surgery, average of 3 hours.
Oxygen saturation.
Duration of surgery, average of 3 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arlyne Thung

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

October 6, 2017

Study Completion (Actual)

October 6, 2017

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB12-00503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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