Fluid Overload and Pulmonary Function

Study Overview
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Brief Summary
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Esophageal atresia is a rare but severe malformation, and it requires early surgery. Coloesophagoplasty is surgical repair of the esophageal with an isoperistaltic transverse colon graft. In the postoperative period after coloesophagoplasty children require careful monitoring of fluid balance, because clinically significant fluid overload can lead to dysfunction of various organs and systems.

Detailed Description
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Esophageal atresia (EA) is a defect of the embryogenesis of the laryngotracheal tube. There are isolated forms of EA and combinations with a tracheoesophageal fistula (TPF). Esophageal plastic surgery with an isoperistaltic transplant from the transverse colon was performed in children with EA. After this surgical intervention children require observation in the intensive care unit (ICU). During this period, infusion therapy satisfies physiological needs and compensates for physiological and pathological losses. However, it is not always possible to compensate for the body's fluid needs and maintain a normovolemic state. Thus, fluid overload develops. It is based on a pathophysiological process when severe operational stress leads to the damage of glycocalyx in the vascular wall. As a result, albumin freely passes into the interstitium, and oncotic pressure rises in tissues. Fluid overload in the intra- and postoperative period can be a factor in an unfavorable outcome, leading to organ damage, as well as death.

Official Title
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Fluid Overload and Pulmonary Function After Coloesophagoplasty in Children. Single-central Observational Study

Conditions
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Water-Electrolyte Imbalance, Intensive Care Units, Pediatric, Critical Illness, Length of Stay, Respiratory Failure, Esophageal Atresia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Аge from 1 month to 3 years EA with / without Tracheoesophageal fistula (TPF) Сoloesophagoplasty. Exclusion Criteria: Аesophageal burn, Oesophageal peptic stenosis, Congenital heart disease Cardiotonic support in the postoperative period Renal malformations Bacterial pneumonia in the postoperative period, Bronchopulmonary malformations.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of intensive care unit (ICU) stay | number of days in ICU after surgery before discharge | up to 30 days after the surgery | 
| duration of mechanical ventilation (MV) | number of days of MV after surgery before switching to continuous positive airway pressure (CPAP) | up to 30 days after the surgery | 
| intraoperative fluid overload (IVF) | ((injected fluid (ml) - diuresis (ml) - blood loss (ml))/weight before surgery)*100% | during the surgery | 
| fluid overload (FO) on the first postoperative day in the ICU | ((injected fluid (ml)-lost fluid (ml))/weight before admission to ICU)*100% | during the first postoperative day, exclude intraoperative period | 
| total fluid overload on the first postoperative day | ((injected fluid (ml) - lost fluid (ml))/weight before surgery)*100% | during the first postoperative day, include intraoperative period | 
| Fraction of Inspired Oxygen (FiO2) | Fraction of Inspired Oxygen (FiO2) | in the the first postoperative day | 
| Fraction of Inspired Oxygen (FiO2) | Fraction of Inspired Oxygen (FiO2) | in the second postoperative day | 
| Fraction of Inspired Oxygen (FiO2) | Fraction of Inspired Oxygen (FiO2) | in the third postoperative day | 
| Oxygen saturation (Sp02) | Oxygen saturation (Sp02) | in the first postoperative day | 
| Oxygen saturation (Sp02) | Oxygen saturation (Sp02) | in the second postoperative day | 
| Oxygen saturation (Sp02) | Oxygen saturation (Sp02) | in the third postoperative day | 
| Venous oxygen saturation (Svo2) | Venous oxygen saturation (Svo2) | in the first postoperative day | 
| Venous oxygen saturation (Svo2) | Venous oxygen saturation (Svo2) | in the second postoperative day | 
| Venous oxygen saturation (Svo2) | Venous oxygen saturation (Svo2) | in the third postoperative day | 
| partial pressure of carbon dioxide (pC02) | partial pressure of carbon dioxide (pC02) | in the first postoperative day | 
| partial pressure of carbon dioxide (pC02) | partial pressure of carbon dioxide (pC02) | in the second postoperative day | 
| partial pressure of carbon dioxide (pC02) | partial pressure of carbon dioxide (pC02) | in the third postoperative day | 
| inspiratory pressure (Pin) | inspiratory pressure (Pin) | in the first postoperative day | 
| inspiratory pressure (Pin) | inspiratory pressure (Pin) | in the second postoperative day | 
| inspiratory pressure (Pin) | inspiratory pressure (Pin) | in the third postoperative day | 
| Positive end-expiratory pressure (PEEP) | Positive end-expiratory pressure (PEEP) | in the first postoperative day | 
| Positive end-expiratory pressure (PEEP) | Positive end-expiratory pressure (PEEP) | in the second postoperative day | 
| Positive end-expiratory pressure (PEEP) | Positive end-expiratory pressure (PEEP) | in the third postoperative day | 
| duration of ICU stay corrected to sedation | duration of ICU stay corrected for the duration of sedation | up to 30 days after the surgery | 
| duration of MV corrected to sedation | duration of MV corrected for the duration of sedation | up to 30 days after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liquid, Liquid overload, Mechanical ventilation, Infant, Preschool Child, Respiratory failure, Coloesophagoplasty, Esophageal atresia