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

July 26, 2023 updated by: Petr Štourač, MD, Brno University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
    • State
      • Brno, State, Czechia, 62500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Paediatric patients on mechanical ventilation in anaesthesia departmentand in intensive care department

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Paediatric patients anaesthesia
Paediatric patients who underwent diagnostic or surgical procedure under general anaesthesia with the need for mechanical ventilation in the selected time period.
Other: Data from anaesthesia records for ventilation setting screening
Data from anaesthesia records will be retrospectively screened for the ventilation settings
Other Names:
  • Retrospective data analysis
Paediatric patients intensive care
Paediatric patients admitted to the paediatric intensive care unit with the need for mechanical ventilation in the selected time period
Other: Data from intensive care records for ventilation setting screening
Data from paediatric intensive care charts will be retrospectively screened for the ventilation settings
Other Names:
  • Retrospective data analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tidal volume
Time Frame: Intraoperative period
Tidal volume will be evaluated in the paediatric patients in anaesthesia and in intensive care unit
Intraoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive end-expiratory pressure settings according to the inspiration fraction of oxygen
Time Frame: Intraoperative period
Positive end-expiratory pressure will be evaluated in the paediatric patients in anaesthesia and in intensive care unit
Intraoperative period
Driving pressure
Time Frame: Intraoperative period
Driving pressure will be calculated from peak pressure minus PEEP in patients on mechanical ventilation in anaesthesia and in intensive care unit
Intraoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brno University Hospital

Investigators

  • Study Chair: Petr Stourac, assoc.Prof.MD.Ph.D, University Hospital Brno

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

March 9, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KDAR FN Brno 2019/3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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