NCT03877354

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

4.8 years

First QC Date

March 9, 2019

Last Update Submit

July 26, 2023

Conditions

Keywords

ventilationpaediatric patientmechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Tidal volume

    Tidal volume will be evaluated in the paediatric patients in anaesthesia and in intensive care unit

    Intraoperative period

Secondary Outcomes (2)

  • Positive end-expiratory pressure settings according to the inspiration fraction of oxygen

    Intraoperative period

  • Driving pressure

    Intraoperative period

Study Arms (2)

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

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

Interventions

Data from anaesthesia records will be retrospectively screened for the ventilation settings

Also known as: Retrospective data analysis
Paediatric patients anaesthesia

Data from paediatric intensive care charts will be retrospectively screened for the ventilation settings

Also known as: Retrospective data analysis
Paediatric patients intensive care

Eligibility Criteria

AgeUp to 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Age outside selected limits
  • Insufficient data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Brno

Brno, State, 62500, Czechia

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Petr Stourac, assoc.Prof.MD.Ph.D

    University Hospital Brno

    STUDY CHAIR

Central Study Contacts

Petr Stourac, assoc.Prof.MD.Ph.D

CONTACT

Jozef Klucka, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc.prof.MD,Ph.D

Study Record Dates

First Submitted

March 9, 2019

First Posted

March 15, 2019

Study Start

April 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations