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Trial record 49 of 33704 for:    value

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

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ClinicalTrials.gov Identifier: NCT03851679
Recruitment Status : Completed
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Bove, University of Udine

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


Condition or disease Intervention/treatment
Pregnancy Related Diagnostic Test: B-Type natriuretic peptide (BNP) serum values Device: Pulmonary echography Other: urine collection

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pulmonary Echography and BNP Value Pre- and Post- Elective Cesarean Section in Spinal Anesthesia
Actual Study Start Date : December 17, 2016
Actual Primary Completion Date : August 8, 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
pregnancy woman
woman who are submitted to elective Cesarean Section in spinal anesthesia
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




Primary Outcome Measures :
  1. Ultrasound pulmonary variations [ Time Frame: pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery ]
    The main goal of our study is to evaluate, preoperatively, the incidence of ultrasound pulmonary variations in pregnant women attending elective Cesarean Section


Secondary Outcome Measures :
  1. subclinical pulmonary echography variation [ Time Frame: pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery ]
    Evaluating the incidence of subclinical variations in ecographic lung characteristics at 6 and 24 hours after Cesarean Section

  2. B-type natriuretic peptide serum value variation [ Time Frame: 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 ]
    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

  3. fluid administration and pulmonary echography variation [ Time Frame: pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery ]
    Finding if there is any correlation between intraoperative fluids administered and ecographic lung characteristics



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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

Publications:
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Responsible Party: Bove, Professor, University of Udine
ClinicalTrials.gov Identifier: NCT03851679     History of Changes
Other Study ID Numbers: BNP and pulmonary echography
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bove, University of Udine:
pulmonary echography
B-Type natriuretic peptide
Spinal anesthesia
Additional relevant MeSH terms:
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Natriuretic Peptide, Brain
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Natriuretic Agents