NCT02033772

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2017

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

4.2 years

First QC Date

November 22, 2013

Last Update Submit

January 11, 2018

Conditions

Congenital Diaphragmatic HerniaTracheoesophageal FistulaEsophageal Atresia

Outcome Measures

Primary Outcomes (1)

  • Change in transcutaneous CO2

    Duration of surgery, average of 3 hours.

Secondary Outcomes (4)

  • Change in ET-CO2

    Duration of surgery, average of 3 hours.

  • Change in heart rate

    Duration of surgery, average of 3 hours.

  • Change in blood pressure

    Duration of surgery, average of 3 hours.

  • Change in SpO2

    Duration of surgery, average of 3 hours.

Study Arms (1)

Thoracoscopic surgery

Infants undergoing thoracoscopic surgery.

Procedure: Thoracoscopic surgery

Interventions

Thoracoscopic surgeryPROCEDURE
Thoracoscopic surgery

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants \< 6 months of age undergoing thoracoscopic surgery.

You may qualify if:

  • Patients presenting for thoracoscopic surgery
  • Patients aged ≤ 6 months of age

You may not qualify if:

  • Patients presenting for any procedure other than thoracoscopic surgery
  • Patients aged \> 6 months of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Hernias, Diaphragmatic, CongenitalTracheoesophageal FistulaEsophageal Atresia

Interventions

Thoracoscopy

Condition Hierarchy (Ancestors)

Congenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsEsophageal FistulaDigestive System FistulaDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesRespiratory Tract FistulaRespiratory Tract DiseasesTracheal DiseasesFistulaDigestive System Abnormalities

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

November 22, 2013

First Posted

January 13, 2014

Study Start

August 1, 2013

Primary Completion

October 6, 2017

Study Completion

October 6, 2017

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

US(1)