Fluid Overload and Pulmonary Function

Sponsor

Pirogov Russian National Research Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05129930

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Water-Electrolyte Imbalance Intensive Care Units Pediatric Critical Illness Length of Stay Respiratory Failure Esophageal Atresia

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.

Study Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Actual Primary Completion Date :

Feb 20, 2021

Actual Study Completion Date :

May 1, 2021

Outcome Measures

Primary Outcome Measures

duration of intensive care unit (ICU) stay [up to 30 days after the surgery]
number of days in ICU after surgery before discharge
duration of mechanical ventilation (MV) [up to 30 days after the surgery]
number 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 ICU [during the first postoperative day, exclude intraoperative period]
((injected fluid (ml)-lost fluid (ml))/weight before admission to ICU)*100%
total fluid overload on the first postoperative day [during 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 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]
Fraction of Inspired Oxygen (FiO2)
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]
Oxygen saturation (Sp02)
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]
Venous oxygen saturation (Svo2)
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]
partial pressure of carbon dioxide (pC02)
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]
inspiratory pressure (Pin)
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]
Positive end-expiratory pressure (PEEP)
duration of ICU stay corrected to sedation [up to 30 days after the surgery]
duration of ICU stay corrected for the duration of sedation
duration of MV corrected to sedation [up to 30 days after the surgery]
duration of MV corrected for the duration of sedation