Mechanical VentilationNCT01348295
Pediatric Ventilatory Care in Finland 2010
An observational study of Mechanical Ventilation and Children, run by University of Oulu at 1 site in Finland.
Trial summary
This observational study includes questionnaires send to doctors in all units treating pediatric patients with mechanical ventilation in Finland. Additionally all units treating pediatric patients with mechanical ventilation are invited to perform a quality control-like follow up for 3 months. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Mechanical Ventilation, Children, Neonates
- What is being tested?
- Observation
- How many people
- 210 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2010to Dec 2010
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: All children under 16 years needing mechanical ventilation in Finland from 13th of September 2010 to 19th of December 2010.
Who may be able to join
- Age under 16 years
- Mechanical ventilation during the follow up period
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This observational study includes questionnaires send to doctors in all units treating pediatric patients with mechanical ventilation in Finland. Additionally all units treating pediatric patients with mechanical ventilation are invited to perform a quality control-like follow up for 3 months. Patient identity data is not collected, and no interventions to treatment are made.
- Conditions
- Mechanical Ventilation, Children, Neonates, Pediatric Intensive Care
- Being tested
- Observation
- Keywords
- Mechanical ventilation, Children, Neonates, Pediatric intensive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
No interventions are made. The purpose of the study is to find out current practices used in pediatric mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Mechanically ventilated children | All children under 16 years of age who are needing mechanical ventilation for any reason. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of mechanical ventilation
Compare the duration of mechanical ventilation in different units in Finland
Measured: 1-2000 hours
Secondary outcomes (1)
Ventilator parameters
Comparison of ventilator parameters used during mechanical ventilation of children in pediatric-, neonatal- and adult intensive care units.
Measured: 1-2000hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348295
- Sponsor's protocol ID
- FIN2010
- Status last verified
- May 2011
- First submitted
- 3 May 2011
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Ventilatory Care in Finland 2010
- ClinicalTrials.gov ID
- NCT01348295
- Acronym / sponsor ID
- FIN2010
- Conditions
- Mechanical Ventilation, Children, Neonates, Pediatric Intensive Care
- Keywords
- Mechanical ventilation, Children, Neonates, Pediatric intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 May 2011 (estimated)
- 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.
This observational study includes questionnaires send to doctors in all units treating pediatric patients with mechanical ventilation in Finland. Additionally all units treating pediatric patients with mechanical ventilation are invited to perform a quality control-like follow up for 3 months. Patient identity data is not collected, and no interventions to treatment are made.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated children | – | Other: ObservationAll children under 16 years of age who are needing mechanical ventilation for any reason. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children under 16 years needing mechanical ventilation in Finland from 13th of September 2010 to 19th of December 2010.
Key inclusion criteria (2 listed)
- Age under 16 years
- Mechanical ventilation during the follow up period
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ObservationNo interventions are made. The purpose of the study is to find out current practices used in pediatric mechanical ventilation. | Other | Mechanically ventilated children |
Primary outcome
The duration of mechanical ventilation
Time frame: 1-2000 hours
Compare the duration of mechanical ventilation in different units in Finland
1 secondary outcome
Ventilator parameters
Time frame: 1-2000hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mechanical Ventilation and Children, run by University of Oulu at 1 site in Finland.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 5 May 2011. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of mechanical ventilation (time frame: 1-2000 hours). 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 5 May 2011.