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

NCT ID: NCT02033772

Last Updated: 2018-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-10-06

Brief Summary

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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

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Conditions

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Congenital Diaphragmatic Hernia Tracheoesophageal Fistula Esophageal Atresia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Thoracoscopic surgery

Infants undergoing thoracoscopic surgery.

Thoracoscopic surgery

Intervention Type PROCEDURE

Interventions

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Thoracoscopic surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arlyne Thung

OTHER

Sponsor Role lead

Responsible Party

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Arlyne Thung

Assistant Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB12-00503

Identifier Type: -

Identifier Source: org_study_id

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