Maternal Microcirculation & SDF Imaging

NCT02376192 | Completed Phase 4 DMC

• 1 other identifier: IWK1010276
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Keywords

Microcirculation; Sidestream Dark Field (SDF) Imaging; Spinal Anesthesia; Phenylephrine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Microvascular Flow Index (MFI)

  Immediately prior to, and within 10 minutes of induction of spinal anesthesia

Other Outcomes (3)

• Total Vessel Density (TVD)

  Immediately prior to, and within 10 minutes of induction of spinal anesthesia

• Perfused Vessel Density (PVD)

  Immediately prior to, and within 10 minutes of induction of spinal anesthesia

• Proportion of perfused vessels (PPV)

  Immediately prior to, and within 10 minutes of induction of spinal anesthesia

Study Arms (2)

Bolus Phenylephrine/Ephedrine Treatment'

EXPERIMENTAL

Initial MicroScan® (Microvision Medical) SDF measurement are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia. In the operating room participants will receive a standard spinal anesthetic (hyperbaric bupivacaine, fentanyl and preservative free morphine) followed by a second comparative MicroScan® (Microvision Medical) SDF measurement within 10 minutes of initiation of spinal anesthetic. Participants who experience hypotension will receive bolus phenylephrine and/or ephedrine treatment as needed.

Device: Initial MicroScan® (Microvision Medical) SDF Measurement; Drug: Spinal Anesthesia- Bupivacaine; Device: Comparative MicroScan® (Microvision Medical) SDF Measurement; Drug: Bolus Phenylephrine/Ephedrine Treatment

Phenylephrine Infusion Group

EXPERIMENTAL

Initial MicroScan® (Microvision Medical) SDF measurement are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia. In the operating room participants will receive a standard spinal anesthetic (hyperbaric bupivacaine, fentanyl and preservative free morphine) followed by a second comparative MicroScan® (Microvision Medical) SDF measurement within 10 minutes of initiation of spinal anesthetic. Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension.

Device: Initial MicroScan® (Microvision Medical) SDF Measurement; Drug: Spinal Anesthesia- Bupivacaine; Device: Comparative MicroScan® (Microvision Medical) SDF Measurement; Drug: Phenylephrine Infusion

Interventions

Initial MicroScan® (Microvision Medical) SDF Measurement DEVICE

Initial SDF measurements are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia.

Bolus Phenylephrine/Ephedrine Treatment'; Phenylephrine Infusion Group

Spinal Anesthesia- Bupivacaine DRUG

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.

Bolus Phenylephrine/Ephedrine Treatment'; Phenylephrine Infusion Group

Comparative MicroScan® (Microvision Medical) SDF Measurement DEVICE

A second comparative SDF measurement be recorded within 10 minutes after induction of spinal anesthesia.

Bolus Phenylephrine/Ephedrine Treatment'; Phenylephrine Infusion Group

Bolus Phenylephrine/Ephedrine Treatment DRUG

Participants who experience hypotension following induction of spinal anesthesia will be treated with a bolus of phenylephrine and/or ephedrine as needed.

Bolus Phenylephrine/Ephedrine Treatment'

Phenylephrine Infusion DRUG

Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension.

Phenylephrine Infusion Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I - Healthy, ASA II - mild and controlled systemic disease)
• Singleton pregnancies
• weeks gestation
• Non-labouring
• Scheduled cesarean delivery
• English speaking
• Age 18-45 years

You may not qualify if:

• 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

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (4)

• 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.

  PMID: 24934438 BACKGROUND

• Abdo I, George RB, Farrag M, Cerny V, Lehmann C. Microcirculation in pregnancy. Physiol Res. 2014;63(4):395-408. doi: 10.33549/physiolres.932511. Epub 2014 Apr 3.

  PMID: 24702490 BACKGROUND

• 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.

  PMID: 24342223 BACKGROUND

• 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.

  PMID: 24448730 BACKGROUND

Study Officials

• Ronald B George, MD FRCPC

  IWK Health Centre, Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Medical Research

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: March 3, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 3, 2015

Record last verified: 2015-02

Locations

CA (1)