Pulmonary Echography and BNP Value Pre- and Post- Elective Cesarean Section in Spinal Anesthesia

NCT03851679 | Completed

• 1 other identifier: BNP and pulmonary echography
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pregnancy is characterized by many biohumoral changes: circulation, respiratory mechanics, oncotic pressure, vascular permeability and many other systems are affected. Vascular permeability is controlled by endothelial glycocalyx. Several factors such as sepsis, ischemia / reperfusion, inflammatory mediators, trauma, surgery including the Cesarean Section and fluid overload can increase vascular permeability due to a glycocalyx damage. During Cesarean Section under subarachnoid anesthesia, hypotension may occur. It is a common side effect caused by reduced preload due to aortocaval compression by the uterus. Furthermore, subarachnoid anesthesia causes block of the sympathetic preganglionic fibers which is associated with vasodilation. These changes often require the use of vasopressors and fluids. A fluid overload associated with the physiological and pathological factors discussed earlier might cause an increased risk of pulmonary edema and acute respiratory failure (IRA) in women undergoing cesarean section under arachnoid anesthesia. IRA occurs in less than 0.2% of total pregnancies but it is one of the most common cause of admission to intensive care unit in pregnant women. Among the causes that can lead to IRA in the last trimester of pregnancy we find pneumopathies such as asthma, pulmonary embolism due to amniotic fluid and pulmonary edema related to severe preeclampsia. Diagnosis of pulmonary edema can be clinical or sub-clinical through laboratory tests such as BNP (b-type natriuretic peptide). It might also be necessary to execute instrumental examinations such as chest radiography (contraindicated in pregnancy) or trans-thoracic ultrasound. Hypothesis: correlation between subarachnoid anesthesia, fluidic therapy and BNP values and ultrasound pattern

Conditions

Pregnancy Related

Keywords

pulmonary echography; B-Type natriuretic peptide; Spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• Ultrasound pulmonary variations

  The main goal of our study is to evaluate, preoperatively, the incidence of ultrasound pulmonary variations in pregnant women attending elective Cesarean Section

  pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery

Secondary Outcomes (3)

• subclinical pulmonary echography variation

  pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery

• B-type natriuretic peptide serum value variation

  B-type natriuretic peptide serum level is sampled 30 minutes before Cesarean Section, 6 and 24 hours after surgery 30 minutes before Cesarean Section, 6 and 24 hours after surgery

• fluid administration and pulmonary echography variation

  pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery

Study Arms (1)

pregnancy woman

woman who are submitted to elective Cesarean Section in spinal anesthesia

Diagnostic Test: B-Type natriuretic peptide (BNP) serum values; Device: Pulmonary echography; Other: urine collection

Interventions

B-Type natriuretic peptide (BNP) serum values DIAGNOSTIC_TEST

evaluation BNP serum values: * pre- Cesarean Section (30 minutes before surgery) * post- Cesarean Section (6 hour and 24 hour after surgery)

pregnancy woman

Pulmonary echography DEVICE

Pulmonary echography: * pre- Cesarean Section (30 minutes before surgery) * post- Cesarean Section (6 hour and 24 hour after surgery)

pregnancy woman

urine collection OTHER

6 hour and 24 hour urine collection after Cesarean Section

pregnancy woman

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients' anthropometric data were collected, data related to the anesthetic technique, pharmacological and intraoperative fluid therapy, sensory level reached after subarachnoid anesthesia, sensory level and motor blockade at discharge from the operating room. We also collected BNP serum values and pulmonary ultrasound images at 6 and 24 h after the intervention. Diuresis collection at 6 and 24 h after the intervention was registered as well as water balance.

You may qualify if:

• woman submit elective Cesarean Section:
• age \> 18 years
• American Society of Anesthesiologists (ASA) physical status classification system \> 2
• \> 37 gestational age
• arterial pressure \>/ = 140/90 mmHg and proteinuria \< 300 mmHg during anesthesia pre-examination
• no known cardiovascular/respiratory disease
• pre-partum pulmonary echography

You may not qualify if:

• age \< 18 years
• pulmonary echographic windows not satisfying
• blood loss during Cesarean Section more than 1000 mL and/or necessity to administer colloid
• postpartum hemorrhage within the first 24 hours following childbirth
• pre-eclamptic sign/symptoms within the first 5 days following childbirth
• twin pregnancy

Sponsors & Collaborators

• University of Udine: lead

Related Publications (6)

• Bamfo JE, Kametas NA, Nicolaides KH, Chambers JB. Maternal left ventricular diastolic and systolic long-axis function during normal pregnancy. Eur J Echocardiogr. 2007 Oct;8(5):360-8. doi: 10.1016/j.euje.2006.12.004. Epub 2007 Feb 23.

  PMID: 17321800 BACKGROUND

• Campos O, Andrade JL, Bocanegra J, Ambrose JA, Carvalho AC, Harada K, Martinez EE. Physiologic multivalvular regurgitation during pregnancy: a longitudinal Doppler echocardiographic study. Int J Cardiol. 1993 Jul 15;40(3):265-72. doi: 10.1016/0167-5273(93)90010-e.

  PMID: 8225661 BACKGROUND

• Lapinsky SE. Acute respiratory failure in pregnancy. Obstet Med. 2015 Sep;8(3):126-32. doi: 10.1177/1753495X15589223. Epub 2015 Jun 10.

  PMID: 27512467 BACKGROUND

• Pereira A, Krieger BP. Pulmonary complications of pregnancy. Clin Chest Med. 2004 Jun;25(2):299-310. doi: 10.1016/j.ccm.2004.01.010.

  PMID: 15099890 BACKGROUND

• Chappell D, Jacob M, Hofmann-Kiefer K, Conzen P, Rehm M. A rational approach to perioperative fluid management. Anesthesiology. 2008 Oct;109(4):723-40. doi: 10.1097/ALN.0b013e3181863117.

  PMID: 18813052 BACKGROUND

• Resnik JL, Hong C, Resnik R, Kazanegra R, Beede J, Bhalla V, Maisel A. Evaluation of B-type natriuretic peptide (BNP) levels in normal and preeclamptic women. Am J Obstet Gynecol. 2005 Aug;193(2):450-4. doi: 10.1016/j.ajog.2004.12.006.

  PMID: 16098869 BACKGROUND

MeSH Terms

Interventions

Urine Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 22, 2019
• Study Start: December 17, 2016
• Primary Completion: August 8, 2018
• Study Completion: November 1, 2018
• Last Updated: February 22, 2019

Record last verified: 2019-02