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Fluid Overload and Pulmonary Function

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05129930
Enrollment
40
Registered
2021-11-22
Start date
2020-12-01
Completion date
2021-05-01
Last updated
2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Liquid, Liquid overload, Mechanical ventilation, Infant, Preschool Child, Respiratory failure, Coloesophagoplasty, Esophageal atresia

Brief summary

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

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.

Interventions

None listed

Sponsors

Pirogov Russian National Research Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 3 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
partial pressure of carbon dioxide (pC02)in the first postoperative daypartial pressure of carbon dioxide (pC02)
total fluid overload on the first postoperative dayduring the first postoperative day, include intraoperative period((injected fluid (ml) - lost fluid (ml))/weight before surgery)\*100%
Fraction of Inspired Oxygen (FiO2)in the the first postoperative dayFraction of Inspired Oxygen (FiO2)
Oxygen saturation (Sp02)in the first postoperative dayOxygen saturation (Sp02)
Venous oxygen saturation (Svo2)in the first postoperative dayVenous oxygen saturation (Svo2)
duration of intensive care unit (ICU) stayup to 30 days after the surgerynumber of days in ICU after surgery before discharge
duration of mechanical ventilation (MV)up to 30 days after the surgerynumber of days of MV after surgery before switching to continuous positive airway pressure (CPAP)
intraoperative fluid overload (IVF)during the surgery((injected fluid (ml) - diuresis (ml) - blood loss (ml))/weight before surgery)\*100%
fluid overload (FO) on the first postoperative day in the ICUduring the first postoperative day, exclude intraoperative period((injected fluid (ml)-lost fluid (ml))/weight before admission to ICU)\*100%
inspiratory pressure (Pin)in the first postoperative dayinspiratory pressure (Pin)
Positive end-expiratory pressure (PEEP)in the first postoperative dayPositive end-expiratory pressure (PEEP)
duration of ICU stay corrected to sedationup to 30 days after the surgeryduration of ICU stay corrected for the duration of sedation
duration of MV corrected to sedationup to 30 days after the surgeryduration of MV corrected for the duration of sedation

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026