Respiratory InsufficiencyNCT02358460
Pressure-limited Ventilation Versus Volume-targeted Ventilation in Term Newborns
A study testing Ventilation delivered by SLE5000 ventilator in people with Respiratory Insufficiency, run by King's College London at 2 sites in United Kingdom.
Trial summary
A randomised controlled trial comparing volume-targeted ventilation to pressure-limited ventilation in infants born at or near term. Read more about this study
- Who is it for?
- Ages 1 minute to 4 weeks
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Ventilation delivered by SLE5000 ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2011to Sep 2014
- Phase
- Interventional
- 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 1 minute to 4 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mechanically ventilated
- Born at gestation 34 weeks and above
Who cannot join
- Congenital diaphragmatic hernia
- Congenital heart disease
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
King's College Hospital NHS Foundation Trust
London, London, SE5 9RS
Neonatal Intensive Care Unit
London, SE5 9RS
About this study
Official title: Randomised Controlled Trial Comparing Volume-targeted to Pressure-limited Ventilation in Infants Born at or Near Term
A randomised controlled trial comparing volume-targeted ventilation to pressure-limited ventilation in infants born at or near term.
Read the detailed description
Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. It is not known whether the same is true in the case of infants born at term. This study aims to compare pressure-limited to VTV in term-born infants.
Hypothesis: Volume-targeted will be associated with significantly earlier extubation compared to pressure-limited ventilation Primary outcome: Time to extubation. Methods: Ventilated infants 34 weeks or more gestational age at birth were recruited and randomly allocated to receive either pressure-limited or VTV. Adjustments to ventilator settings were made according to the trial protocol. Infants were deemed to have met failure criteria if they required HFOV or peak pressures of more than 30 cm of water. Analysis will be by intention-to-treat.
- Conditions
- Respiratory Insufficiency
- Being tested
- Ventilation delivered by SLE5000 ventilator
- Keywords
- neonatal, respiratory, mechanical ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation delivered by SLE5000 ventilatorDevice
In pressure-limited ventilation arm, ventilator settings as required to maintain appropriate oxygenation and carbon-dioxide elimination.
In volume-targeted ventilation arm, set target volume at 5ml/kg and wean rate. In both arms, aim to keep blood gases within normal limits.
| Study group | Role | What they receive |
|---|---|---|
| Pressure-limited ventilation | Active comparator | Not described Receives: Device: Ventilation delivered by SLE5000 ventilator |
| Volume-targeted ventilation | Active comparator | Not described Receives: Device: Ventilation delivered by SLE5000 ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation
Data will be collected from the intensive care observation chart to determine the time at which the infant was successfully taken off of mechanical ventilation, assessed up to 4 weeks.
Measured: For each patient, the exact number of hours from the date and time of randomisation to the date and time of successful removal of the endotracheal tube, assessed up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startMay 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Greenough, MD, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358460
- Sponsor's protocol ID
- 07/H0808/147-3
- Status last verified
- Feb 2015
- First submitted
- 13 Jan 2015
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Comparing Volume-targeted to Pressure-limited Ventilation in Infants Born at or Near Term
- ClinicalTrials.gov ID
- NCT02358460
- Acronym / sponsor ID
- 07/H0808/147-3
- Conditions
- Respiratory Insufficiency
- Keywords
- neonatal, respiratory, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Feb 2015 (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.
A randomised controlled trial comparing volume-targeted ventilation to pressure-limited ventilation in infants born at or near term.
Detailed description
Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. It is not known whether the same is true in the case of infants born at term. This study aims to compare pressure-limited to VTV in term-born infants.
Hypothesis: Volume-targeted will be associated with significantly earlier extubation compared to pressure-limited ventilation Primary outcome: Time to extubation. Methods: Ventilated infants 34 weeks or more gestational age at birth were recruited and randomly allocated to receive either pressure-limited or VTV. Adjustments to ventilator settings were made according to the trial protocol. Infants were deemed to have met failure criteria if they required HFOV or peak pressures of more than 30 cm of water. Analysis will be by intention-to-treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure-limited ventilation | Active comparator | Device: Ventilation delivered by SLE5000 ventilator |
| Volume-targeted ventilation | Active comparator | Device: Ventilation delivered by SLE5000 ventilator |
Who may qualify
- Ages
- 1 minute to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Mechanically ventilated
- Born at gestation 34 weeks and above
Key exclusion criteria (2 listed)
- Congenital diaphragmatic hernia
- Congenital heart disease
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 |
|---|---|---|
| Ventilation delivered by SLE5000 ventilatorIn pressure-limited ventilation arm, ventilator settings as required to maintain appropriate oxygenation and carbon-dioxide elimination. In volume-targeted ventilation arm, set target volume at 5ml/kg and wean rate. In both arms, aim to keep blood gases within normal limits. | Device | Pressure-limited ventilation, Volume-targeted ventilation |
Primary outcome
Duration of mechanical ventilation
Time frame: For each patient, the exact number of hours from the date and time of randomisation to the date and time of successful removal of the endotracheal tube, assessed up to 4 weeks.
Data will be collected from the intensive care observation chart to determine the time at which the infant was successfully taken off of mechanical ventilation, assessed up to 4 weeks.
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 9 Feb 2015.
Related trials for Respiratory Insufficiency
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Anne Greenough, MD principal investigator
King's College Hospital NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation delivered by SLE5000 ventilator in people with Respiratory Insufficiency, run by King's College London at 2 sites in United Kingdom.
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 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: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Duration of mechanical ventilation (time frame: For each patient, the exact number of hours from the date and time of randomisation to the date and time of successful removal of the endotracheal tube, assessed up to 4 weeks.). 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 9 Feb 2015.