The Effect of Fluids on Aortic VTI During C-section

NCT04330742 | Recruiting DMC

• 1 other identifier: H45744
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnancy is associated with a myriad of physiologic changes, including expansion of blood volume, decrease in oncotic pressure, and increased cardiac output. The obstetric population is associated with intrapartum hemorrhage. Accordingly, it is important to have an accurate method to assess fluid status in intrapartum patients. The use of standard volume assessment tools including arterial lines and central venous catheters is limited given the brevity of obstetric procedures and the morbidity of these techniques on the awake patients, and the costs. Non-invasive methods to assess volume status (carotid dopplers, direct measurement of blood loss, bio-impedance devices) are imperfect. Echocardiography is an attractive tool to measure fluid status in experienced operators such as anesthesiologists. IVC diameter and variation of aortic velocity time integral are two measures that can be obtained via echocardiography and been studied in spontaneously breathing patients. The purpose of this study is to determine whether these measurements can be used in the assessment of volume status in the laboring patient.

Conditions

Pregnancy Related; Hemorrhage; Fluid Overload; Labor Complication

Keywords

obstetrics; fluid responsiveness; fluid resuscitation

Outcome Measures

Primary Outcomes (1)

• aortic velocity time integral

  the percent change in aortic velocity time integral as measured by transthoracic echo

  at baseline measure, right after spinal placement (250mL LR), at 500mL LR infusion, and at 1 L LR infusion (approximately 20mins)

Secondary Outcomes (3)

• inferior vena cava collapsibility

  at baseline measure, right after spinal placement (250mL LR), at 500mL LR infusion, and at 1 L LR infusion (approximately 20mins)

• change in systolic blood pressure

  every 2.5 mins for 20 mins (when 1L LR is administered) once the pt has a spinal placement

• change in heart rate

  every 2.5 mins for 20 mins (when 1L LR is administered) once the pt has a spinal placement

Study Arms (4)

0 mL crystalloid

These are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 0, at which time 0 mL of fluids will have been administered.

Drug: lactated ringers

250 mL crystalloid.

These are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 1, after the spinal has been placed and approximately 250 mL fluids has been administered.

Drug: lactated ringers

500 mL crystalloid

These are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 2, at which time 500 mL of fluids will have been administered.

Drug: lactated ringers

1000 mL crystalloid

These are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 3, at which time 1000 mL of fluids will have been administered.

Drug: lactated ringers

Interventions

lactated ringers DRUG

the intervention is one liter fluid bag of lactated ringers which is routinely used as a fluid coload for spinal anesthesia. All patients will receive the same amount of fluids however this will be paused at various time points in order to perform the echocardiogram.

Also known as: crystalloid

0 mL crystalloid; 1000 mL crystalloid; 250 mL crystalloid.; 500 mL crystalloid

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All patients ages 18-35 undergoing elective cesarean section with planned spinal anesthetic at Ben Taub General Hospital (BTGH) will be screened. Consenting patients will undergo spinal anesthetic prior to planned procedure. All subjects will receive the same 1L fluid bolus intraoperatively.

You may qualify if:

• healthy nulliparous or multiparous pregnant women with a term (\>37 weeks gestation)
• age 18-35
• singleton pregnancy
• scheduled for Cesarean delivery with planned neuraxial spinal or combined spinal epidural anesthesia
• American Society for Anesthesiologists physical status 2

You may not qualify if:

• Patients without ability to provide informed consent
• American Society for Anesthesiologists physical status 3 or 4
• Emergency cesarean section
• BMI\>40
• Known cardiac and pulmonary comorbidities including chronic hypertension, preeclampsia, gestational hypertension, diabetes, asthma, renal disease
• Age \> 35

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Ben Taub General Hospital

Houston, Texas, 77030, United States

RECRUITING

Related Publications (13)

• Ngan Kee WD, Khaw KS, Ng FF. Prevention of hypotension during spinal anesthesia for cesarean delivery: an effective technique using combination phenylephrine infusion and crystalloid cohydration. Anesthesiology. 2005 Oct;103(4):744-50. doi: 10.1097/00000542-200510000-00012.

  PMID: 16192766 BACKGROUND

• Zieleskiewicz L, Noel A, Duclos G, Haddam M, Delmas A, Bechis C, Loundou A, Blanc J, Mignon A, Bouvet L, Einav S, Bourgoin A, Leone M. Can point-of-care ultrasound predict spinal hypotension during caesarean section? A prospective observational study. Anaesthesia. 2018 Jan;73(1):15-22. doi: 10.1111/anae.14063. Epub 2017 Oct 7.

  PMID: 28986931 BACKGROUND

• Zieleskiewicz L, Bouvet L, Einav S, Duclos G, Leone M. Diagnostic point-of-care ultrasound: applications in obstetric anaesthetic management. Anaesthesia. 2018 Oct;73(10):1265-1279. doi: 10.1111/anae.14354. Epub 2018 Jul 26.

  PMID: 30047997 BACKGROUND

• Lamia B, Ochagavia A, Monnet X, Chemla D, Richard C, Teboul JL. Echocardiographic prediction of volume responsiveness in critically ill patients with spontaneously breathing activity. Intensive Care Med. 2007 Jul;33(7):1125-1132. doi: 10.1007/s00134-007-0646-7. Epub 2007 May 17.

  PMID: 17508199 BACKGROUND

• McIntyre JP, Ellyett KM, Mitchell EA, Quill GM, Thompson JM, Stewart AW, Doughty RN, Stone PR; Maternal Sleep in Pregnancy Study Group. Validation of thoracic impedance cardiography by echocardiography in healthy late pregnancy. BMC Pregnancy Childbirth. 2015 Mar 28;15:70. doi: 10.1186/s12884-015-0504-5.

  PMID: 25886289 BACKGROUND

• Hancock A, Weeks AD, Lavender DT. Is accurate and reliable blood loss estimation the 'crucial step' in early detection of postpartum haemorrhage: an integrative review of the literature. BMC Pregnancy Childbirth. 2015 Sep 28;15:230. doi: 10.1186/s12884-015-0653-6.

  PMID: 26415952 BACKGROUND

• Airapetian N, Maizel J, Alyamani O, Mahjoub Y, Lorne E, Levrard M, Ammenouche N, Seydi A, Tinturier F, Lobjoie E, Dupont H, Slama M. Does inferior vena cava respiratory variability predict fluid responsiveness in spontaneously breathing patients? Crit Care. 2015 Nov 13;19:400. doi: 10.1186/s13054-015-1100-9.

  PMID: 26563768 BACKGROUND

• Brun C, Zieleskiewicz L, Textoris J, Muller L, Bellefleur JP, Antonini F, Tourret M, Ortega D, Vellin A, Lefrant JY, Boubli L, Bretelle F, Martin C, Leone M. Prediction of fluid responsiveness in severe preeclamptic patients with oliguria. Intensive Care Med. 2013 Apr;39(4):593-600. doi: 10.1007/s00134-012-2770-2. Epub 2012 Dec 6.

  PMID: 23223774 BACKGROUND

• Muller L, Bobbia X, Toumi M, Louart G, Molinari N, Ragonnet B, Quintard H, Leone M, Zoric L, Lefrant JY; AzuRea group. Respiratory variations of inferior vena cava diameter to predict fluid responsiveness in spontaneously breathing patients with acute circulatory failure: need for a cautious use. Crit Care. 2012 Oct 8;16(5):R188. doi: 10.1186/cc11672.

  PMID: 23043910 BACKGROUND

• Maizel J, Airapetian N, Lorne E, Tribouilloy C, Massy Z, Slama M. Diagnosis of central hypovolemia by using passive leg raising. Intensive Care Med. 2007 Jul;33(7):1133-1138. doi: 10.1007/s00134-007-0642-y. Epub 2007 May 17.

  PMID: 17508202 BACKGROUND

• Gardin JM, Davidson DM, Rohan MK, Butman S, Knoll M, Garcia R, Dubria S, Gardin SK, Henry WL. Relationship between age, body size, gender, and blood pressure and Doppler flow measurements in the aorta and pulmonary artery. Am Heart J. 1987 Jan;113(1):101-9. doi: 10.1016/0002-8703(87)90016-0.

  PMID: 2948377 BACKGROUND

• Tawfik MM, Tarbay AI, Elaidy AM, Awad KA, Ezz HM, Tolba MA. Combined Colloid Preload and Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2019 Feb;128(2):304-312. doi: 10.1213/ANE.0000000000003306.

  PMID: 29461392 BACKGROUND

• Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.

  PMID: 26580836 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Edema; Obstetric Labor Complications

Interventions

Ringer's Lactate; Crystalloid Solutions

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Amy Lee, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Yi Deng, MD

  Baylor College of Medicine

  STUDY DIRECTOR

• Claudia Wei, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Lee, MD

CONTACT

713-793-8805; amy.lee@bcm.edu

Claudia Wei, MD

CONTACT

cwei@bcm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetric Anesthesiology

Study Record Dates

• First Submitted: March 28, 2020
• First Posted: April 1, 2020
• Study Start: March 25, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)