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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00985764
Other study ID # 4-2007-0006
Secondary ID
Status Completed
Phase N/A
First received September 25, 2009
Last updated November 3, 2010
Start date May 2007
Est. completion date September 2009

Study information

Verified date October 2010
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

Effects of placenta previa on incidence and severity of venous air embolism in patients during cesarean delivery


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy Volunteer with cesarean delivery

Exclusion Criteria:

- the one who rejects to participate

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
cesarean delivery


Locations

Country Name City State
Korea, Republic of Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary read sonography records during the surgery Three sono views will be recorded rapidly for later interpretation of the stage of air embolism. The midesophageal (ME) 4-chamber view will be continuously monitored during surgery and videotaped. When a bubble is detected in the right atrium (RA), the probe will be turned to the right side and the angle was adjusted to the ME bicaval view to confirm its entrance from the inferior vena cava. Then, the angle will be rapidly re-adjusted to view the ME right ventricle (RV) inflow-outflow view to confirm the extent of air embolism through the right ventricular outflow tract (RVOT). After 1 or 2 weeks of surgery No