Comparison of Tidal Volume Between Pediatric Anaesthesia and Paediatric Intensive Care Patients

Protective Ventilation Clinical Trial

— TIVAC  

Official title:

Comparison of Tidal Volume Between Pediatric Anaesthesia and Paediatric Intensive Care Patients: Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03877354
• Other study ID #: KDAR FN Brno 2019/3
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Brno University Hospital
• Contact: Petr Stourac, assoc.Prof.MD.Ph.D
• Phone: 532234404
• Email: stourac.petr[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Paediatric anaesthesiology and paediatric intensive care unit data will be retrospectively screened for the data regarding mechanical ventilation. The primary aim will be the tidal volume setting and the secondary the level of positive end-expiration pressure (PEEP) according to the inspired oxygen fraction (FIO2), and the level of driving pressure.

Description:

Protective positive pressure ventilation (tidal volume ≤6 mL/kg) in adult patients in intensive care is currently considered as a standard procedure. It is associated with a reduction of morbidity and positive outcome. In paediatric patients there are available only limited information related to the size of the tidal volume and it is recommended to use the volume between 5 and 8 mL per kg for the whole spectrum of ages of pediatric patients. The aim of this retrospective observational study is to evaluate the tidal volumes used in clinical practice in pediatric patients during general anesthesia and compared it to the tidal volumes used in paediatric critical care. Data will be harvested from the anaesthesiology records and from the paediatric intensive care unit charts. The tidal volume will calculated per kg of actual weight.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 19 Years

Eligibility

Inclusion Criteria:

• Paediatric patients on mechanical ventilation in anaesthesia department

• Paediatric patients on mechanical ventilation in intensive care department

• In selected study period between 1.1.2018 - 31.1.2019

Exclusion Criteria:

• Age outside selected limits

• Insufficient data

Related Conditions & MeSH terms

• Protective Ventilation

Intervention

Other:
• Data from anaesthesia records for ventilation setting screening
Data from anaesthesia records will be retrospectively screened for the ventilation settings
• Data from intensive care records for ventilation setting screening
Data from paediatric intensive care charts will be retrospectively screened for the ventilation settings

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno	State

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tidal volume	Tidal volume will be evaluated in the paediatric patients in anaesthesia and in intensive care unit	Intraoperative period
Secondary	Positive end-expiratory pressure settings according to the inspiration fraction of oxygen	Positive end-expiratory pressure will be evaluated in the paediatric patients in anaesthesia and in intensive care unit	Intraoperative period
Secondary	Driving pressure	Driving pressure will be calculated from peak pressure minus PEEP in patients on mechanical ventilation in anaesthesia and in intensive care unit	Intraoperative period