Protective VentilationTIVACNCT03877354
Comparison of Tidal Volume Between Pediatric Anaesthesia and Paediatric Intensive Care Patients
An observational study of Protective Ventilation, run by Brno University Hospital at 1 site in Czechia.
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)… Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Protective Ventilation
- What is being tested?
- Data from anaesthesia records for ventilation setting screening and Data from intensive care records for ventilation setting screening
- How many people
- 1,000 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Paediatric patients on mechanical ventilation in anaesthesia departmentand in intensive care department
Who may be able to join
- 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
Who cannot join
- Age outside selected limits
- Insufficient data
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Brno
Brno, State, 62500
Jozef Klučka, MD, 532234696, Klucka.jozef@fnbrno.cz
Petr Stourac, assoc.Prof.MD.Ph.D, 532234404, Stourac.Petr@fnbrno.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- Protective Ventilation
- Being tested
- Data from anaesthesia records for ventilation setting screening, Data from intensive care records for ventilation setting screening
- Keywords
- ventilation, paediatric patient, mechanical ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data from anaesthesia records for ventilation setting screeningOther
Also called Retrospective data analysis
Data from anaesthesia records will be retrospectively screened for the ventilation settings
Data from intensive care records for ventilation setting screeningOther
Also called Retrospective data analysis
Data from paediatric intensive care charts will be retrospectively screened for the ventilation settings
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Data from intensive care records for ventilation setting screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
Tidal volume will be evaluated in the paediatric patients in anaesthesia and in intensive care unit
Measured: Intraoperative period
Secondary outcomes (2)
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
Measured: Intraoperative period
Driving pressure
Driving pressure will be calculated from peak pressure minus PEEP in patients on mechanical ventilation in anaesthesia and in intensive care unit
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Apr 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protective VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Stourac, assoc.Prof.MD.Ph.D, Study chair, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877354
- Sponsor's protocol ID
- KDAR FN Brno 2019/3
- Acronym
- TIVAC
- Status last verified
- Jul 2023
- First submitted
- 9 Mar 2019
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tidal Volume Between Pediatric Anaesthesia and Paediatric Intensive Care Patients: Retrospective Study
- ClinicalTrials.gov ID
- NCT03877354
- Acronym / sponsor ID
- TIVAC / KDAR FN Brno 2019/3
- Conditions
- Protective Ventilation
- Keywords
- ventilation, paediatric patient, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paediatric patients anaesthesia | – | Other: Data from anaesthesia records for ventilation setting screeningPaediatric patients who underwent diagnostic or surgical procedure under general anaesthesia with the need for mechanical ventilation in the selected time period. |
| Paediatric patients intensive care | – | Other: Data from intensive care records for ventilation setting screeningPaediatric patients admitted to the paediatric intensive care unit with the need for mechanical ventilation in the selected time period |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Paediatric patients on mechanical ventilation in anaesthesia departmentand in intensive care department
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Age outside selected limits
- Insufficient data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data from anaesthesia records for ventilation setting screeningAlso: Retrospective data analysisData from anaesthesia records will be retrospectively screened for the ventilation settings | Other | Paediatric patients anaesthesia |
| Data from intensive care records for ventilation setting screeningAlso: Retrospective data analysisData from paediatric intensive care charts will be retrospectively screened for the ventilation settings | Other | Paediatric patients intensive care |
Primary outcome
Tidal volume
Time frame: Intraoperative period
Tidal volume will be evaluated in the paediatric patients in anaesthesia and in intensive care unit
2 secondary outcomes
Positive end-expiratory pressure settings according to the inspiration fraction of oxygen
Time frame: Intraoperative period
Driving pressure
Time frame: Intraoperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: Undecided
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PROtective Ventilation With FLOW-Controlled Ventilation
Postoperative Pulmonary Complications (PPCs), Feasibility Studies
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Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
Postoperative Pulmonary Complications, Mechanical Ventilation
Not yet recruiting
Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery
Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs)
Not yet recruitingPhase 1/2
Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Stourac, assoc.Prof.MD.Ph.D study chair
Brno University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Protective Ventilation, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petr Stourac, assoc.Prof.MD.Ph.D (532234404, stourac.petr@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal volume (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.