Critical Illness Clinical Trial
Official title:
Fluid Overload and Pulmonary Function After Coloesophagoplasty in Children. Single-central Observational Study
Verified date | December 2020 |
Source | Pirogov Russian National Research Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | N.F. Filatov Childrens city hospital | Moscow |
Lead Sponsor | Collaborator |
---|---|
Pirogov Russian National Research Medical University |
Russian Federation,
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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