Prospective Data Collection of Patients < 6 Months of Age Undergoing Thoracoscopic Surgery
Sponsor
Arlyne Thung (Other)
Overall Status
Completed
CT.gov ID
NCT02033772
Collaborator
(none)
17
1
50.2
0.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
17 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Study Start Date
:
Aug 1, 2013
Actual Primary Completion Date
:
Oct 6, 2017
Actual Study Completion Date
:
Oct 6, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Thoracoscopic surgery Infants undergoing thoracoscopic surgery. |
Procedure: Thoracoscopic surgery
|
Outcome Measures
Primary Outcome Measures
- Change in transcutaneous CO2 [Duration of surgery, average of 3 hours.]
Secondary Outcome Measures
- Change in ET-CO2 [Duration of surgery, average of 3 hours.]
End-tidal CO2
- Change in heart rate [Duration of surgery, average of 3 hours.]
- Change in blood pressure [Duration of surgery, average of 3 hours.]
Non-invasive and invasive.
- Change in SpO2 [Duration of surgery, average of 3 hours.]
Oxygen saturation.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 6 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
Sponsors and Collaborators
- Arlyne Thung
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Arlyne Thung,
Assistant Clinical Professor,
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT02033772
Other Study ID Numbers:
- IRB12-00503
First Posted:
Jan 13, 2014
Last Update Posted:
Jan 12, 2018
Last Verified:
Jan 1, 2018
Additional relevant MeSH terms: