Clinical trial NCT03127865: Evaluation of Electrical Velocimetry for Assessment of Extra-vascular Lung Water in Pre-eclamptic Patients
Official title: Evaluation of Electrical Velocimetry for Assessment of Extra-vascular Lung Water in Pre-eclamptic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Eclampsia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-eclamptic patients scheduled for normal vaginal delivery or casearen section

Brief summary: The purpose of this study is to compare the sensitivity and the specificity of electrical cardiometry to the lung ultrasound in measuring thoracic lung water in pregnant females with pre-eclampsia. If electrical cardiometry is validated against ultrasound, it will be easy to use with numerical number that will not require advanced experience as with the ultrasound.

Detailed description: Pre-eclampsia is accompanied with increased risk of serious complications such as pulmonary edema, cerebrovascular accidents, coagulopathy, and hemorrhage.

Pre-eclampsia is responsible for 46.6% of the etiology of acute pulmonary edema in pregnant women.

Fluid management in pre-eclamptic patients is challenging. Hypovolemia exacerbates organ failure, whereas volume overload results in pulmonary edema. Thus, using different methods for evaluation of volume status of the patients would improve patient management. Lung ultrasound has been developed as an accurate non-invasive method for assessment of extra-vascular lung water; However, ultrasound needs skilled operator. Electrical velocimetry (cardiometry) is a newer technology for assessment of total thoracic fluid content (TFC); however, it has not been validated in pre-eclamptic patients.

In this study the investigators will validate the accuracy of cardiometry in evaluation of lung water using the lung ultrasound as a gold standard. Both methods will be evaluated for prediction of the need of diuretic therapy and the need for post-operative oxygen therapy.

Eligibility criteria: Inclusion Criteria:

* pregnant
* pre-eclamptic
* In first stage of labor

Exclusion Criteria:

* Eclampsia.
* Second, third and fourth stages of labor on admission.
* Patients with severe cardiac and/or pulmonary disease.

Primary outcomes:
measure: total thoracic fluid content
timeFrame: after 30 minutes from patient admission to the obstetric casuality
Secondary outcomes:
measure: The need of diuretics
timeFrame: during the period starting from admission till one day after delivery
measure: extra-vascular lung water
timeFrame: after 30 minutes from patient admission to the obstetric casuality
measure: lung congestion
timeFrame: during the period starting from admission till one day after delivery
measure: serum albumin
timeFrame: after 30 minutes from patient admission to the obstetric casuality
measure: arterial blood pressure
timeFrame: after 30 minutes from patient admission to the obstetric casuality
measure: heart rate
timeFrame: after 30 minutes from patient admission to the obstetric casuality
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of research committee section in anesthesia department
name: Ahmed Mukhtar, Professor
role: STUDY_CHAIR
References: