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

Pregnancy Clinical Trial

Official title:

Influence of the Method of Alleviation of Aorto-Caval Compression on the Trans-Hepatic Ultrasound-Assessed Inferior Vena Cava Diameter In Pregnant Patients: An Observational Study of the Left Lateral Tilt and of the Left Uterine Displacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982513
• Other study ID #: 13-09
• Status: Completed
• Phase: N/A
• First received: November 6, 2013
• Last updated: June 3, 2014
• Start date: November 2013
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Description:

Using the non-invasive technology of ultrasound we will be able to determine the degree of aorto-caval compression in pregnant women placed in different positions. The results of this study will help us to determine the optimal patient positioning for each individual. This in future may help us in improving outcomes not only during labor and anesthesia, but also during maternal resuscitation in critical cases.

The results of this study will help us to determine the best technique to minimize aorto-caval compression in the term pregnant patient. The results of this study will be useful to establish firm maternal resuscitation guidelines. We will be able to determine the optimal maternal position during cardiopulmonary resuscitation and this may improve both maternal and fetal resuscitation outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• ASA I or II

• Term pregnancy (36-40 weeks)

• Singleton pregnancy

Exclusion Criteria:

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IVC maximum diameter	The IVC maximum diameter in each position (measured during expiration).	20 minutes	No
Secondary	Fetal Heart Rate	The fetal heart rate will be monitored during the last minute of observation in each position.	20 minutes	Yes
Secondary	Maternal vitals	Maternal blood pressure and heart rate will be monitored during the last minute of observation in each position.	20 minutes	Yes
Secondary	IVC minimum diameter	The IVC minimum diameter in each position (measured during inspiration).	20 minutes	No
Secondary	IVC Index	IVC index (IVI) = IVC(max)-IVC (min)/IVC(max)	20 minutes	No