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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851679
• Other study ID #: BNP and pulmonary echography
• Status: Completed
• Start date: December 17, 2016
• Est. completion date: November 2018

Study information

• Verified date: February 2019
• Source: University of Udine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2018
• Est. primary completion date: August 8, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Diagnostic Test:
• B-Type natriuretic peptide (BNP) serum values
evaluation BNP serum values: pre- Cesarean Section (30 minutes before surgery) post- Cesarean Section (6 hour and 24 hour after surgery)

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

Other:
• urine collection
6 hour and 24 hour urine collection after Cesarean Section

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Udine

References & 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. Epub 2007 Feb 23. — View Citation

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. — View Citation

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. Review. — View Citation

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

Pereira A, Krieger BP. Pulmonary complications of pregnancy. Clin Chest Med. 2004 Jun;25(2):299-310. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	subclinical pulmonary echography variation	Evaluating the incidence of subclinical variations in ecographic lung characteristics at 6 and 24 hours after Cesarean Section	pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery
Secondary	B-type natriuretic peptide serum value variation	Finding if there is any correlation between preoperative b-type natriuretic peptide and ecographic lung characteristics in pregnants, before and 24 hours after Cesarean Section	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
Secondary	fluid administration and pulmonary echography variation	Finding if there is any correlation between intraoperative fluids administered and ecographic lung characteristics	pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery