Maternal Microcirculation & SDF Imaging

Pregnancy Clinical Trial

Official title:

Maternal Microcirculation & SDF Imaging: A Novel Assessment of the Microcirculation During Cesarean Delivery With Spinal Anesthesia and the Impact of Phenylephrine Prophylaxis to Prevent Spinal Anesthesia-induced Hypotension.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376192
• Other study ID #: IWK1010276
• Status: Completed
• Phase: Phase 4
• First received: September 3, 2014
• Last updated: February 25, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This is a study of pregnant women undergoing a cesarean delivery. It will compare their microcirculation before and after the anesthetic. Microcirculation means blood flow to the extremely small blood vessels in the body. It will also look at the differences in microcirculation of participants who receive an infusion of phenylephrine compared to participants who don't. The investigators hypothesize that spinal anesthesia will reduce the vascular density and proportion of perfused vessels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I - Healthy, ASA II - mild and controlled systemic disease)

• Singleton pregnancies

• 36-42 weeks gestation

• Non-labouring

• Scheduled cesarean delivery

• English speaking

• Age 18-45 years

Exclusion Criteria:

• Cardiovascular disease

• Hypertensive disease of pregnancy (i.e. mild & severe preeclampsia)

• Allergy to phenylephrine, or any other standardized medication

• Obesity (BMI > 35 kg/m2)

• Diabetes Mellitus type 1

• Smoker

• Coffee/Caffeine intake within 6 hours of SDF measurement

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• Initial MicroScan® (Microvision Medical) SDF Measurement
Initial SDF measurements are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia.

Drug:
• Spinal Anesthesia- Bupivacaine
The spinal anesthetic technique is standardized. In the operating room spinal anesthesia will be administered with the L2-L5 interspaces in the sitting position using 12 mg of hyperbaric bupivacaine with 15 mcg of fentanyl and 150 mcg of preservative free morphine.

Device:
• Comparative MicroScan® (Microvision Medical) SDF Measurement
A second comparative SDF measurement be recorded within 10 minutes after induction of spinal anesthesia.

Drug:
• Bolus Phenylephrine/Ephedrine Treatment
Participants who experience hypotension following induction of spinal anesthesia will be treated with a bolus of phenylephrine and/or ephedrine as needed.
• Phenylephrine Infusion
Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension.

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Abdo I, George RB, Farrag M, Cerny V, Lehmann C. Microcirculation in pregnancy. Physiol Res. 2014;63(4):395-408. Epub 2014 Apr 3. Review. — View Citation

George RB, DesRoches J, Abdo I, Lehmann C. Maternal microcirculation and sidestream dark field imaging: a prospective assessment of the association between labour pain and analgesia on the microcirculation of pregnant women. Clin Hemorheol Microcirc. 2015;60(4):389-95. doi: 10.3233/CH-141851. — View Citation

George RB, Munro A, Abdo I, McKeen DM, Lehmann C. An observational assessment of the sublingual microcirculation of pregnant and non-pregnant women. Int J Obstet Anesth. 2014 Feb;23(1):23-8. doi: 10.1016/j.ijoa.2013.08.013. Epub 2013 Sep 8. — View Citation

Lehmann Ch, Abdo I, Kern H, Maddison L, Pavlovic D, Sharawi N, Starkopf J, Hall R, Johnson P, Williams L, Cerny V; MiDAS (Microcirculation Diagnostics and Applied Studies) group. Clinical evaluation of the intestinal microcirculation using sidestream dark field imaging--recommendations of a round table meeting. Clin Hemorheol Microcirc. 2014;57(2):137-46. doi: 10.3233/CH-141810. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total Vessel Density (TVD)		Immediately prior to, and within 10 minutes of induction of spinal anesthesia	No
Other	Perfused Vessel Density (PVD)		Immediately prior to, and within 10 minutes of induction of spinal anesthesia	No
Other	Proportion of perfused vessels (PPV)		Immediately prior to, and within 10 minutes of induction of spinal anesthesia	No
Primary	Microvascular Flow Index (MFI)	The change in MFI of participants; measured immediately prior to, and within 10 minutes following the induction of spinal anesthesia	Immediately prior to, and within 10 minutes of induction of spinal anesthesia	No
Secondary	Microvascular Flow Index (MFI)	The difference between the MFI measured within 10 minutes following the induction of spinal anesthesia in participants who receive phenylephrine via a continuous infusion for the prevention of spinal anesthesia-induced hypotension compared to those who may receive phenylephrine boluses for treatment of spinal anesthesia-induced hypotension.	Immediately prior to, and within 10 minutes of induction of spinal anesthesia	No