Correlation of Survival in Puerperae by Electrical Impedance Tomography

Introduction: Electrical Impedance Tomography (TIE) consists of an equipment that enables the visualization / quantification in real time of the regional distribution of ventilation and pulmonary perfusion, as well as of ventilatory mechanics. Used on the edge of the bed, it is easy to move, non-invasive, allowing a momentary or continuous assessment, guiding the conduct in a safe and precise way through the electrical impedance technology. It is important to note that, in addition to ensuring the efficacy of the patient's behavior, the TIE supports the most diverse types of studies to be performed. These include those based on the effectiveness of the use of the method in the most diverse pulmonary dysfunctions, in the adjustment of the mechanical ventilation and in the average time of hospitalization. Objective: To evaluate the pulmonary function of patients in invasive mechanical ventilation through SIT. Method: This research was carried out in compliance with the National Health Council's Guidelines for Research Involving Human Beings (466/12). The study was a prospective longitudinal clinical-experimental type in which all patients (occasional sampling) used mechanical ventilation and were hospitalized in the Adult Intensive Care Unit (ICU) of the Santa Casa de Misericórdia Foundation of Pará, and they developed sepsis with pulmonary repercussions; (DEHG) / HELLP Syndrome and Adult Respiratory Distress Syndrome (ARDS) and who met the inclusion criteria were evaluated and monitored with TIE to perform ventilatory therapy according to the research objectives. The research was carried out in the city of Belém, in the state of Pará, in the adult ICU of the FSCMP. As inclusion criterion, the patient should be in the FSCMP adult Intensive Care Unit (ICU), under mechanical invasive ventilation, previously authorized by the family through the Informed Consent Form to participate in the study.

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Key information

Conditions

Postpartum Period Female Urogenital Diseases and Pregnancy Complications HELLP Syndrome Hypertension, Pregnancy-Induced Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome,Adult Respiratory Tract Diseases Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases

Sex eligibility

Female

Study type

Observational

About this study

A prospective longitudinal clinical-experimental study was carried out in which 30 postpartum / postpartum women who developed complications of their clinical condition, needing support by invasive mechanical ventilation, development of sepsis with pulmonary repercussion, Specific Pregnancy Disease ( SDP), HELLP syndrome or ARDS were evaluated and monitored with Electrical Impedance Tomography for conduction of ventilatory therapy. In order to obtain the images and quantification of the regional ventilatory distribution, two tapes with 16 electrodes were connected by means of an adhesive tape, one for each band, around the thorax and aligned in a plane corresponding to a cross section with emission of an electric current imperceptible and harmless to the patient, generating, according to the pulmonary dynamics, a variation of electrical impedance, consequently a gradient of electrical resistivity. A flow sensor positioned between the endotracheal tube and the "Y" of the ventilator circuit, responsible for capturing ventilatory mechanic information, and a reference cable positioned by an electrocardiographic monitoring electrode, in the abdominal region or in the region from the shoulders. The data were sent simultaneously to a system (computer) with specific softwear in order to measure and quantify the regional distribution of pulmonary ventilation and perfusion, as well as its correlation in patients under mechanical ventilation. All experimental values were presented as mean ± standard deviation (SD). The study was of the experimental type, and the descriptive statistic was used to characterize the sample. Statistical analysis was performed with GraphPad Prism 5.0. The P value <0.05 was considered statistically significant. The results were placed in spreadsheets and graphs created with GraphPad Prism 5.0 (GraphPad Software, San Diego, California, USA).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

the patient should:

To be admitted to the Adult Intensive Care Unit (ICU) of the FSCMP;
Being in the postpartum/puerperium period;
To evolve with complications of its clinical condition: sepsis with pulmonary repercussions, Specific Disease of Pregnancy (SDP), HELLP syndrome or ARDS;
Support by invasive mechanical ventilation;
To be previously authorized by the family to participate in the study through the WICF.

Exclusion criteria

Being a cardiac pacemaker;
Pregnant women in any period of gestation who develop complications of their clinical condition and need support through invasive ventilation.

Treatment and study plan

sepsis

Other

Evaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy.

HELLP Syndrome

Other

Evaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy.

Respiratory Distress Syndrome Adult

Other

Evaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy.

Primary outcomes

Correlation of the driving pressure with the survival of puerperae under mechanical ventilation by electrical impedance tomography

Time frame: Data will be collected 3 times a day in the morning, evening and evening hours until the conclusion of the study, with a mean of 3 to 5 days of monitoring by electrical impedance tomography

For the delimitation of the information collection of postpartum women submitted to invasive mechanical ventilation for having evolved with HELLP syndrome, sepsis or respiratory distress syndrome, and ventilatory data were collected from the data sheet of the Electrical Impedance Tomography, containing data from the regional distribution of (Cst) of the respiratory system, final expiratory positive pressure (PEEP) and Platelet Pressure (Pplatô), as well as ventilatory parameters data: Ventilatory mode and mode, PEEP, VT, Inspiratory Time (I), Inspired Fraction of Oxygen (FiO2), Sensitivity (Sens.), Of hospitalized patients in the period of collections. After a retrospective survey of the sample, data were collected from patients who were in the Intensive Care Unit, while they were on invasive mechanical ventilation and monitored by Electrical Impedance Tomography.

Sponsors and collaborators

Lead sponsor

Amazon University

Other

Collaborators

Santa Casa de Misericórdia do Pará

Registry information

Official study title

Correlation of the Driving Pressure With the Survival of Puerperae Under Mechanical Ventilation by Electrical Impedance Tomography

Acronym: COSIPBEIT

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2018
First posted: Oct 23, 2018
Registry last updated: Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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