Influence of the Method of Alleviation of Aorto-Caval Compression on the Trans-Hepatic Ultrasound-Assessed Inferior Vena Cava Diameter In Pregnant Patients

NCT01982513 | Completed

• 1 other identifier: 13-09
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac arrest during pregnancy is rare but may result in poor maternal and fetal outcome. Because of its rare occurrence and ethical issues this topic is not very well studied and many questions pertaining to maternal resuscitation remain unanswered. One of the challenging aspects of cardiopulmonary resuscitation in a term pregnant patient is the ideal positioning during chest compressions. International societies have made recommendations regarding management of pregnant patients during cardiac arrest. They advocate the use of left lateral position with 30 degrees tilt or manual uterine displacement. However these recommendations are not based on high level of evidence. Ultrasound has been used to visualize the change in diameter of great vessels to determine the volume status or adequacy of blood circulation of these patients. This approach can be used to study the adequacy of blood circulation of pregnant patients in different positions. The objective of this study is to compare the change in Inferior vena cava diameter obtained with pregnant women in either the left lateral tilt or in the supine position with a manual uterine displacement, compared to the left lateral position and the supine position. Our hypothesis is that the inferior vena cava diameter obtained in the supine position with manual left uterine displacement would be larger as compared to that obtained with women positioned with a 30-degree tilt.

Conditions

Pregnancy; Cardiac Arrest

Keywords

Cardiopulmonary Resuscitation; Pregnancy; Ultrasound; Inferior Vena Cava

Outcome Measures

Primary Outcomes (1)

• IVC maximum diameter

  The IVC maximum diameter in each position (measured during expiration).

  20 minutes

Secondary Outcomes (4)

• Fetal Heart Rate

  20 minutes

• Maternal vitals

  20 minutes

• IVC minimum diameter

  20 minutes

• IVC Index

  20 minutes

Study Arms (1)

Term pregnant patients

ASA I-II term (36-40 weeks) non-laboring women with singleton pregnancies who are admitted at MSH for induction of labor, elective cesarean section or for observation for any medical reason. These patients will be examined in 4 positions with the ultrasound.

Device: Ultrasound

Interventions

Ultrasound DEVICE

The IVC will be visualized and images obtained using the intercostal window in both longitudinal and transverse planes.

Term pregnant patients

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Non-laboring, term prengnant women with singleton pregnancies who are admitted at Mount Sinai Hospital for induction of labor, elective cesarean section or for observation for any medical reason.

You may qualify if:

• ASA I or II
• Term pregnancy (36-40 weeks)
• Singleton pregnancy

You may not qualify if:

• Patients with known cardiac disease, severe preeclampsia on medication
• Multiple gestation
• Breech presentation
• Patients unable to comply with the 4 positions (left lateral, left tilt, supine and supine with manual displacement)
• Patients unable or unwilling to consent

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 13, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

CA (1)