Optic Nerve Sheath Diameter for Volume Status Prediction in Severe Preeclampsia

NCT04367519 | Completed

• 1 other identifier: 6074-26-4-2020
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

A quick, non-invasive, bedside test to assess fluid status of patients with severe preeclampsia would be very helpful to ICU clinicians severe preeclampsia is associated with an increase in extravascular lung water (EVLW), which can be identified by lung ultrasound before appearance of clinical signs of pulmonary edema but this technique still requires several measurements and could be time consuming. Optic ultrasound is also a safe and repeatable diagnostic tool, which is even quicker and simpler to perform than lung ultrasound. Increased ONSD is associated with increased ICP and it can indirectly reflect the state of intracranial edema that could be a part of generalized edema. More data on the correlation between ONSD and markers of fluid status (EVLW by ultrasound) are needed before ONSD measurements can be recommended as a guide to fluid management in preeclampsia.

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• the correlation of ONSD with EVLW

  Ultrasound assessment was performed for all enrolled preeclampsia patients within 24 hour before delivery and at 24 hour post-delivery.

  24 hour

Interventions

Ultrasound measurement of Optic nerve sheath diameter DIAGNOSTIC_TEST

Ocular ultrasonography was performed with the patients placed in supine position with closed eyes. A layer of ultrasound gel was applied over the closed upper eyelid and the liner high frequency probe 7 - 12 MHz of SonoSite M-Turbo ultrasound machine was placed on the temporal area of the eyelid with the hand holding it resting on the forehead of the patient. The probe is then adjusted to a suitable angle in order to display the entry of the optic nerve into the globe. ONSD is then measured 3mm behind the globe in the transverse plane perpendicular to the optic nerve. For each eye one measurement will be made and the reported ONSD corresponds to the mean of the two values obtained for each patient. it was performed for all enrolled parturients within 24 hour before delivery and at 24 hour post-delivery.

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Singleton Pregnant female complicated with severe preeclampsia. severe preeclampsia was determined by the presence of one or more of the following features using the American College of Obstetricians and Gynecologists severe features : * Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg on two occasions at least 4 hours apart * Thrombocytopenia (platelet count less than 100,000/L) * Impaired liver function indicated by elevated liver enzymes (to twice the upper limit normal concentration), and severe persistent right upper quadrant or epigastric pain not responding to medications and not explained by another diagnosis. * Renal insufficiency (serum creatinine concentration more than 1.1 mg/dL or doubling of the serum creatinine concentration in the absence of other renal disease) * Pulmonary edema * New-onset headache unresponsive to medications and not accounted for by alternative diagnoses * Visual disturbances

You may qualify if:

• Patient acceptance.
• Singleton Pregnant female complicated with severe preeclampsia
• Age 18-40 years old.
• Accepted mental state of the patient.

You may not qualify if:

• Patient refusal to participate to the study.
• Mild preeclampsia
• Uncooperative patient or altered sensorium
• Ocular wound
• Pneumonia
• Interstitial lung disease
• History of prior ocular trauma or surgery
• Preexisting heart disease
• Known pulmonary disorders.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Publications (14)

• Hariharan N, Shoemaker A, Wagner S. Pathophysiology of hypertension in preeclampsia. Microvasc Res. 2017 Jan;109:34-37. doi: 10.1016/j.mvr.2016.10.002. Epub 2016 Oct 26. No abstract available.

  PMID: 27793558 BACKGROUND

• Melchiorre K, Sharma R, Thilaganathan B. Cardiovascular implications in preeclampsia: an overview. Circulation. 2014 Aug 19;130(8):703-14. doi: 10.1161/CIRCULATIONAHA.113.003664. No abstract available.

  PMID: 25135127 BACKGROUND

• Dennis AT, Solnordal CB. Acute pulmonary oedema in pregnant women. Anaesthesia. 2012 Jun;67(6):646-59. doi: 10.1111/j.1365-2044.2012.07055.x. Epub 2012 Mar 15.

  PMID: 22420683 BACKGROUND

• Chaiworapongsa T, Chaemsaithong P, Yeo L, Romero R. Pre-eclampsia part 1: current understanding of its pathophysiology. Nat Rev Nephrol. 2014 Aug;10(8):466-80. doi: 10.1038/nrneph.2014.102. Epub 2014 Jul 8.

  PMID: 25003615 BACKGROUND

• Pretorius T, van Rensburg G, Dyer RA, Biccard BM. The influence of fluid management on outcomes in preeclampsia: a systematic review and meta-analysis. Int J Obstet Anesth. 2018 May;34:85-95. doi: 10.1016/j.ijoa.2017.12.004. Epub 2017 Dec 20.

  PMID: 29398426 BACKGROUND

• Zieleskiewicz L, Contargyris C, Brun C, Touret M, Vellin A, Antonini F, Muller L, Bretelle F, Martin C, Leone M. Lung ultrasound predicts interstitial syndrome and hemodynamic profile in parturients with severe preeclampsia. Anesthesiology. 2014 Apr;120(4):906-14. doi: 10.1097/ALN.0000000000000102.

  PMID: 24694847 BACKGROUND

• Shyamsundar M, Attwood B, Keating L, Walden AP. Clinical review: the role of ultrasound in estimating extra-vascular lung water. Crit Care. 2013 Sep 13;17(5):237. doi: 10.1186/cc12710.

  PMID: 24041261 BACKGROUND

• Ambrozic J, Brzan Simenc G, Prokselj K, Tul N, Cvijic M, Lucovnik M. Lung and cardiac ultrasound for hemodynamic monitoring of patients with severe pre-eclampsia. Ultrasound Obstet Gynecol. 2017 Jan;49(1):104-109. doi: 10.1002/uog.17331. Epub 2016 Dec 1.

  PMID: 27736042 BACKGROUND

• Sekhon MS, Griesdale DE, Robba C, McGlashan N, Needham E, Walland K, Shook AC, Smielewski P, Czosnyka M, Gupta AK, Menon DK. Optic nerve sheath diameter on computed tomography is correlated with simultaneously measured intracranial pressure in patients with severe traumatic brain injury. Intensive Care Med. 2014 Sep;40(9):1267-74. doi: 10.1007/s00134-014-3392-7. Epub 2014 Jul 18.

  PMID: 25034476 BACKGROUND

• Pordeus ACB, Katz L, Soares MC, Maia SB, Amorim MMR. Acute pulmonary edema in an obstetric intensive care unit: A case series study. Medicine (Baltimore). 2018 Jul;97(28):e11508. doi: 10.1097/MD.0000000000011508.

  PMID: 29995818 BACKGROUND

• ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.

  PMID: 30575675 BACKGROUND

• Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

  PMID: 22392031 BACKGROUND

• Picano E, Pellikka PA. Ultrasound of extravascular lung water: a new standard for pulmonary congestion. Eur Heart J. 2016 Jul 14;37(27):2097-104. doi: 10.1093/eurheartj/ehw164. Epub 2016 May 12.

  PMID: 27174289 BACKGROUND

• Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.

  PMID: 22258019 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sherif M Mowafy, MD

  Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University

  PRINCIPAL INVESTIGATOR

• Mohamed I Elsayed, MD

  Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: April 29, 2020
• Study Start: October 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: April 15, 2020
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: the individual participant data and any additional supporting information will become available starting 6 months after publication.
• Access Criteria: by contacting the study director

Locations

EG (1)