Venous Air Embolism in Cesarean Delivery, Especially Placental Previa

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00985764
First received: September 25, 2009
Last updated: November 3, 2010
Last verified: October 2010
  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00985764

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
  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 July 31, 2014