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Venous Air Embolism in Cesarean Delivery, Especially Placental Previa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00985764
Recruitment Status : Completed
First Posted : September 28, 2009
Last Update Posted : November 4, 2010
Sponsor:
Information provided by:
Yonsei University

Tracking Information
First Submitted Date September 25, 2009
First Posted Date September 28, 2009
Last Update Posted Date November 4, 2010
Study Start Date May 2007
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 19, 2010)
read sonography records during the surgery [ Time Frame: After 1 or 2 weeks of 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).
Original Primary Outcome Measures
 (submitted: September 25, 2009)
read sonography recorded during the surgery [ Time Frame: after reading sonography ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Venous Air Embolism in Cesarean Delivery, Especially Placental Previa
Official Title Not Provided
Brief Summary Effects of placenta previa on incidence and severity of venous air embolism in patients during cesarean delivery
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population cesarean delivery with placental previa
Condition Cesarean Delivery With Placental Previa
Intervention Procedure: cesarean delivery
Study Groups/Cohorts placental previa
Intervention: Procedure: cesarean delivery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 3, 2010)
80
Original Enrollment Not Provided
Actual Study Completion Date September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Healthy Volunteer with cesarean delivery

Exclusion Criteria:

  • the one who rejects to participate
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT00985764
Other Study ID Numbers 4-2007-0006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ki Jun Kim, Yonsei University, College of Medicine, Dep of Anesthesiology
Study Sponsor Yonsei University
Collaborators Not Provided
Investigators Not Provided
PRS Account Yonsei University
Verification Date October 2010