Venous Air Embolism in Cesarean Delivery, Especially Placental Previa
This study has been completed.
Sponsor:
Yonsei University
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00985764
First received: September 25, 2009
Last updated: November 3, 2010
Last verified: October 2010
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Purpose
Effects of placenta previa on incidence and severity of venous air embolism in patients during cesarean delivery
| Condition | Intervention |
|---|---|
|
Cesarean Delivery With Placental Previa |
Procedure: cesarean delivery |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
Resource links provided by NLM:
Further study details as provided by Yonsei University:
Primary Outcome Measures:
- read sonography records during the surgery [ Time Frame: After 1 or 2 weeks of surgery ] [ Designated as safety issue: No ]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).
| Enrollment: | 80 |
| Study Start Date: | May 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| placental previa | Procedure: cesarean delivery |
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
cesarean delivery with placental previa
Criteria
Inclusion Criteria:
- Healthy Volunteer with cesarean delivery
Exclusion Criteria:
- the one who rejects to participate
Contacts and Locations More Information
No publications provided
| Responsible Party: | Ki Jun Kim, Yonsei University, College of Medicine, Dep of Anesthesiology |
| ClinicalTrials.gov Identifier: | NCT00985764 History of Changes |
| Other Study ID Numbers: | 4-2007-0006 |
| Study First Received: | September 25, 2009 |
| Last Updated: | November 3, 2010 |
| Health Authority: | Korea: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 19, 2013