Neonatal Respiratory FailureNCT01376544
Trial of Weaning by Synchronized Ventilation
A study testing Treatment protocol designed to evaluate (SLE 5000 ventilator) in people with Neonatal Respiratory Failure, run by King's College London at 1 site in United Kingdom.
Trial summary
During assist control ventilation and pressure support ventilation (PSV), the start of ventilator inflation is determined by the start of the infant's inspiratory effort. During PSV, termination of inflation is determined by the level of the infant's inspiratory flow. Read more about this study
- Who is it for?
- Ages 1 day to 14 days
- Conditions the study is for
- Neonatal Respiratory Failure
- What is being tested?
- Treatment protocol designed to evaluate (SLE 5000 ventilator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2008to Aug 2010
- 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 day to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ventilated neonates less than 14 days of age
Who cannot join
- Congenital heart disease, hypoxic ischaemic encephalopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Trial Comparing Assist Control Ventilation to Pressure Support Ventilation During Weaning
During assist control ventilation and pressure support ventilation (PSV), the start of ventilator inflation is determined by the start of the infant's inspiratory effort. During PSV, termination of inflation is determined by the level of the infant's inspiratory flow. In a randomized trial, no significant differences were found between assist control and pressure support ventilation with regard to the duration of weaning, time to successful extubation, work of breathing, rate of asynchrony and level of respiratory muscle strength.
Read the detailed description
Objectives: To test the hypothesis that the duration of weaning would be shorter using assist control ventilation (ACV) rather than pressure support ventilation (PSV). To determine if any differences in the duration of weaning reflected differences in the work of breathing, the rate of asynchrony or the level of respiratory muscle strength.
Patients and methods: Thirty-six infants, median gestational age 29 (range 24 to 39) weeks, were randomized to weaning by either ACV or PSV. The duration of weaning was recorded. At baseline (study entry), 24 hours after entering the study and immediately prior to extubation, the work of breathing was assessed by measuring the transdiaphragmatic pressure time product (PTPdi), thoracoabdominal asynchrony (TAA) was assessed using respiratory inductance plethysmography and respiratory muscle strength measured by recording the maximal inspiratory pressure produced during an airway occlusion during crying (Pimax). Immediately prior to extubation, the level of active expiration was also assessed.
- Conditions
- Neonatal Respiratory Failure
- Being tested
- Treatment protocol designed to evaluate (SLE 5000 ventilator)
- Keywords
- Neonate, Weaning, Assist control ventilation, Pressure support ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment protocol designed to evaluate (SLE 5000 ventilator)Device
Also called SLE 5000 ventilator
Assist control ventilation and pressure support ventilation
| Study group | Role | What they receive |
|---|---|---|
| Assist control ventilation | Active comparator | Assist control ventilation Receives: Device: Treatment protocol designed to evaluate (SLE 5000 ventilator) |
| Pressure support ventilation | Active comparator | Not described Receives: Device: Treatment protocol designed to evaluate (SLE 5000 ventilator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine which mode of ventilation was associated with a shorter duration of weaning.
Measured: Up to 28 days after birth
Secondary outcomes (1)
Change in Work of breathing thoraco-abdominal asynchrony respiratory muscle strength
Measured: Baseline, 24 hours and prior to extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startAug 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Investigators
- Anne Greenough, MD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376544
- Sponsor's protocol ID
- 07/H0808/147
- Status last verified
- Jun 2011
- First submitted
- 26 May 2011
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial Comparing Assist Control Ventilation to Pressure Support Ventilation During Weaning
- ClinicalTrials.gov ID
- NCT01376544
- Acronym / sponsor ID
- 07/H0808/147
- Conditions
- Neonatal Respiratory Failure
- Keywords
- Neonate, Weaning, Assist control ventilation, Pressure support ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 20 Jun 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.
During assist control ventilation and pressure support ventilation (PSV), the start of ventilator inflation is determined by the start of the infant's inspiratory effort. During PSV, termination of inflation is determined by the level of the infant's inspiratory flow. In a randomized trial, no significant differences were found between assist control and pressure support ventilation with regard to the duration of weaning, time to successful extubation, work of breathing, rate of asynchrony and level of respiratory muscle strength.
Detailed description
Objectives: To test the hypothesis that the duration of weaning would be shorter using assist control ventilation (ACV) rather than pressure support ventilation (PSV). To determine if any differences in the duration of weaning reflected differences in the work of breathing, the rate of asynchrony or the level of respiratory muscle strength.
Patients and methods: Thirty-six infants, median gestational age 29 (range 24 to 39) weeks, were randomized to weaning by either ACV or PSV. The duration of weaning was recorded. At baseline (study entry), 24 hours after entering the study and immediately prior to extubation, the work of breathing was assessed by measuring the transdiaphragmatic pressure time product (PTPdi), thoracoabdominal asynchrony (TAA) was assessed using respiratory inductance plethysmography and respiratory muscle strength measured by recording the maximal inspiratory pressure produced during an airway occlusion during crying (Pimax). Immediately prior to extubation, the level of active expiration was also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assist control ventilation | Active comparator | Device: Treatment protocol designed to evaluate (SLE 5000 ventilator)Assist control ventilation |
| Pressure support ventilation | Active comparator | Device: Treatment protocol designed to evaluate (SLE 5000 ventilator) |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Ventilated neonates less than 14 days of age
Key exclusion criteria (1 listed)
- Congenital heart disease, hypoxic ischaemic encephalopathy
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 |
|---|---|---|
| Treatment protocol designed to evaluate (SLE 5000 ventilator)Also: SLE 5000 ventilatorAssist control ventilation and pressure support ventilation | Device | Assist control ventilation, Pressure support ventilation |
Primary outcome
To determine which mode of ventilation was associated with a shorter duration of weaning.
Time frame: Up to 28 days after birth
1 secondary outcome
Change in Work of breathing thoraco-abdominal asynchrony respiratory muscle strength
Time frame: Baseline, 24 hours and prior to extubation
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 20 Jun 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.
Anne Greenough, MD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment protocol designed to evaluate (SLE 5000 ventilator) in people with Neonatal Respiratory Failure, run by King's College London at 1 site 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 1 inclusion and 1 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 20 Jun 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 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?
To determine which mode of ventilation was associated with a shorter duration of weaning. (time frame: Up to 28 days after birth). 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 20 Jun 2011.