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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05129930
Other study ID # FO-Coloesopfagoplasty
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date May 1, 2021

Study information

Verified date December 2020
Source Pirogov Russian National Research Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 1, 2021
Est. primary completion date February 20, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Month to 3 Years
Eligibility Inclusion Criteria: - ?ge from 1 month to 3 years - EA with / without - Tracheoesophageal fistula (TPF) - ?oloesophagoplasty. Exclusion Criteria: - ?esophageal burn, - Oesophageal peptic stenosis, - Congenital heart disease - Cardiotonic support in the postoperative period - Renal malformations - Bacterial pneumonia in the postoperative period, - Bronchopulmonary malformations.

Study Design


Locations

Country Name City State
Russian Federation N.F. Filatov Childrens city hospital Moscow

Sponsors (1)

Lead Sponsor Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary duration of intensive care unit (ICU) stay number of days in ICU after surgery before discharge up to 30 days after the surgery
Primary 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
Primary intraoperative fluid overload (IVF) ((injected fluid (ml) - diuresis (ml) - blood loss (ml))/weight before surgery)*100% during the surgery
Primary 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
Primary 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
Primary Fraction of Inspired Oxygen (FiO2) Fraction of Inspired Oxygen (FiO2) in the the first postoperative day
Primary Fraction of Inspired Oxygen (FiO2) Fraction of Inspired Oxygen (FiO2) in the second postoperative day
Primary Fraction of Inspired Oxygen (FiO2) Fraction of Inspired Oxygen (FiO2) in the third postoperative day
Primary Oxygen saturation (Sp02) Oxygen saturation (Sp02) in the first postoperative day
Primary Oxygen saturation (Sp02) Oxygen saturation (Sp02) in the second postoperative day
Primary Oxygen saturation (Sp02) Oxygen saturation (Sp02) in the third postoperative day
Primary Venous oxygen saturation (Svo2) Venous oxygen saturation (Svo2) in the first postoperative day
Primary Venous oxygen saturation (Svo2) Venous oxygen saturation (Svo2) in the second postoperative day
Primary Venous oxygen saturation (Svo2) Venous oxygen saturation (Svo2) in the third postoperative day
Primary partial pressure of carbon dioxide (pC02) partial pressure of carbon dioxide (pC02) in the first postoperative day
Primary partial pressure of carbon dioxide (pC02) partial pressure of carbon dioxide (pC02) in the second postoperative day
Primary partial pressure of carbon dioxide (pC02) partial pressure of carbon dioxide (pC02) in the third postoperative day
Primary inspiratory pressure (Pin) inspiratory pressure (Pin) in the first postoperative day
Primary inspiratory pressure (Pin) inspiratory pressure (Pin) in the second postoperative day
Primary inspiratory pressure (Pin) inspiratory pressure (Pin) in the third postoperative day
Primary Positive end-expiratory pressure (PEEP) Positive end-expiratory pressure (PEEP) in the first postoperative day
Primary Positive end-expiratory pressure (PEEP) Positive end-expiratory pressure (PEEP) in the second postoperative day
Primary Positive end-expiratory pressure (PEEP) Positive end-expiratory pressure (PEEP) in the third postoperative day
Primary duration of ICU stay corrected to sedation duration of ICU stay corrected for the duration of sedation up to 30 days after the surgery
Primary duration of MV corrected to sedation duration of MV corrected for the duration of sedation up to 30 days after the surgery
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