Correlation of Survival in Puerperae by Electrical Impedance Tomography (COSIPBEIT)

Amazon University

Status: Completed

Conditions: HELLP Syndrome; Postpartum Period; Respiratory Distress Syndrome,Adult; Sepsis

Treatments: Other: Sepsis; Other: Respiratory Distress Syndrome Adult; Other: HELLP Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT03715647

2.251.640

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 30 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

30 participants in 3 patient groups

Sepsis

Description:

The puerperal / postpartum women who evolved with sepsis, needing support by invasive mechanical ventilation, were evaluated and monitored with Electrical Impedance Tomography for ventilatory therapy. In order to obtain the images and quantification of the regional ventilatory distribution, two strips with 16 electrodes were connected around the thorax to capture an imperceptible and harmless electric current to the patient, generating, according to the pulmonary dynamics, an impedance power of variation. A flow sensor was positioned between the endotracheal tube and the "Y" of the ventilator circuit and was responsible for capturing information about ventilatory mechanics. 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 their correlation.

Treatment:

Other: Sepsis

HELLP Syndrome

Description:

The puerperal / postpartum women who evolved with HELLP syndrome, needing support by invasive mechanical ventilation, were evaluated and monitored with Electrical Impedance Tomography for ventilatory therapy. In order to obtain the images and quantification of the regional ventilatory distribution, two strips with 16 electrodes were connected around the thorax to capture an imperceptible and harmless electric current to the patient, generating, according to the pulmonary dynamics, an impedance power of variation. A flow sensor was positioned between the endotracheal tube and the "Y" of the ventilator circuit and was responsible for capturing information about ventilatory mechanics. 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 their correlation.

Treatment:

Other: HELLP Syndrome

Respiratory Distress Syndrome, Adult

Description:

The puerperal / postpartum women who evolved with Adult Respiratory Distress Syndrome, needing support by invasive mechanical ventilation, were evaluated and monitored with Electrical Impedance Tomography for ventilatory therapy. In order to obtain the images and quantification of the regional ventilatory distribution, two strips with 16 electrodes were connected around the thorax to capture an imperceptible and harmless electric current to the patient, generating, according to the pulmonary dynamics, an impedance power of variation. A flow sensor was positioned between the endotracheal tube and the "Y" of the ventilator circuit and was responsible for capturing information about ventilatory mechanics. 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 their correlation.

Treatment:

Other: Respiratory Distress Syndrome Adult