Respiratory Distress, NewbornNCT01514331
Ventilatory Parameters and Inflammatory Responses of Neonates Ventilated by Different Modes of Ventilation
A study testing SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee) and PSV+VG (pressure support ventilation+volume guarantee) in people with Respiratory Distress, Newborn and Ventilator Induced Lung Injury, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The main purpose of this study is to investigate effects of SIMV+VG (synchronized intermittent mandatory ventilation+volume guarantee) or PSV+VG (pressure support ventilation+volume guarantee) ventilation on vital signs, patient - mechanical ventilation synchrony, ventilation parameters and inflammatory mediators in… Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Respiratory Distress, Newborn, Ventilator Induced Lung Injury
- What is being tested?
- SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee) and PSV+VG (pressure support ventilation+volume guarantee)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2012to Nov 2013
- 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 Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- neonates with respiratory distress who need mechanical ventilation
- gestational age less than or equal to 37 weeks
- neonates who need mechanical ventilation within first 24 hours
Who cannot join
- neonates who need mechanical ventilation other than conventional ventilation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Hospital, Department of Pediatrics, Division of Newborn Medicine
Beşevler, Ankara, 06500
About this study
Official title: Determination of Ventilatory Parameters and Inflammatory Responses of Neonates Who Are Ventilated by Volume Guarantee Combined With Synchronized Intermittent Mandatory Ventilation or Pressure Support Ventilation
The main purpose of this study is to investigate effects of SIMV+VG (synchronized intermittent mandatory ventilation+volume guarantee) or PSV+VG (pressure support ventilation+volume guarantee) ventilation on vital signs, patient - mechanical ventilation synchrony, ventilation parameters and inflammatory mediators in neonates.
Read the detailed description
Term or preterm neonates may need mechanical ventilation due to different etiologies. In all patients aim of mechanical ventilation is to promote pulmonary gas exchange, reduce the respiratory work of patient. Ideal mechanical ventilation must minimize pulmonary trauma with low inspiratory pressures that obtains adequate and constant tidal volumes. Ventilation associated pulmonary injury is an important subject that must be considered during mechanical ventilation. Atelectotrauma, volutrauma, barotrauma and biotrauma must be monitored. Volutrauma, barotrauma and oxygen toxicity cause cytokine increase that results in biotrauma. This parenchymal inflammation is a risk factor for chronic lung disease which is an important morbidity of ventilated neonates.
From past to present neonates were ventilated with different ventilation modes including IMV (Intermittent Mandatory Ventilation), SIMV, A/C (Assist Control Ventilation), PSV,HFV (High Frequency Ventilation). Both PSV and SIMV are patient trigger ventilation modes but SIMV is a time cycled and PSV is a flow cycled mode. In recent years hybrid techniques were developed to combine beneficial features of volume and pressure limited ventilation. In commercial ventilation devices these techniques have different names as volume guaranteed pressure limited ventilation (Drager Babylog 8000), pressure regulated volume controlled ventilation (Siemens servo 3000), volume guaranteed pressure support ventilation (VIP Bird Gold).
Since there is not a standard protocol for mechanical ventilation of neonates different countries and even different NICU's use different ventilation protocols.
Literature supports volume targetted ventilation to reduce barotrauma with low maximum inspiratory pressures and to reduce volutrauma with constant tidal volumes. When A/C+VG and SIMV+VG were compared in a crossover trial, more constant tidal volumes were obtained in A/C mode. Inflammatory cytokines have also been measured in different groups of patients with variable ventilatory management techniques. So far there has not been a randomized study published comparing VG+SIMV with VG+PSV in newborns with regards to tidal volume , peak inspiratory pressure variability,or inflammatory cytokines. Therefore in this study the investigators aimed to compare these two ventilation modes with regards to short term outcome.
- Being tested
- SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee), PSV+VG (pressure support ventilation+volume guarantee)
- Keywords
- Ventilator Induced Lung Injury, Neonatal respiratory distress, Mechanical ventilation
- Medical subject headings
- Pulmonary Atelectasis, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee)Other
Also called SIMV + VG mode of ventilation
Neonates who need mechanical ventilation will be ventilated with SIMV+VG mode
PSV+VG (pressure support ventilation+volume guarantee)Other
Also called PSV+ VG mode of ventilation
Neonates who need mechanical ventilation will be ventilated with PSV+VG
| Study group | Role | What they receive |
|---|---|---|
| PSV+VG | Active comparator | Neonates who require mechanical ventilation and randomised to pressure support + volume guarantee (PSV+VG) mode Receives: Other: PSV+VG (pressure support ventilation+volume guarantee) |
| SIMV+VG | Active comparator | Neonates who require mechanical ventilation and randomised to synchronised intermittant mandatory ventilation + volume guarantee (SIMV+VG) mode Receives: Other: SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-1beta levels in tracheal aspirate material
Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported
Measured: Baseline and 72 hours of mechanical ventilation
IL-6 level in tracheal aspirate
Tracheal aspirate will be analyzed for IL6 level and the change from baseline will be reported
Measured: Baseline and 72 hours of mechanical ventilation
IL-8 in tracheal aspirate material
Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported
Measured: Baseline and 72 hours of mechanical ventilation
IL-10 level in tracheal aspirate material
Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported
Measured: Baseline and 72 hours of mechanical ventilation
TNF alfa in tracheal aspirate material
Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported
Measured: Baseline and 72 hours of mechanical ventilation
tidal volume variability
variability in tidal volume measured with babyview program
Measured: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
peak inspiratory pressure variability
variability in peak inspiratory pressure measured with babyview program
Measured: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
respiratory rate variability
changes in respiratory rate, tacypnea rate
Measured: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
oxygen saturation variability
changes in oxygen saturation, desaturation rate, hyperoxy rate
Measured: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
lowest carbondioxide level (mmHg)
ratio of hypocarbic blood gases and least pCo2 level
Measured: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
highest carbondioxide level (mmHg)
ratio of hypercarbic blood gases and highest pCo2 level
Measured: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
lowest oxygen level (mmHg)
ratio of hypoxic blood gases and least pO2 level
Measured: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
highest oxygen level (mmHg)
ratio of hyperoxic blood gases and highest pO2 level
Measured: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
Secondary outcomes (8)
bronchopulmonary dysplasia
Oxygen requirement at 36 weeks corrected age
Measured: 36 weeks corrected age
patent ductus arteriosus
Presence of hemodynamically significant patent ductus arteriosus in the first 7 days of life
Measured: in the first week of post natal life of the patient
necrotizing enterocolitis
Necrotising entercolitis defined by clinical and radiological findings
Measured: 36 weeks corrected age
intraventricular hemorrhage
Intraventricular hemorrhage diagnosed by head ultrasound
Measured: during first week
pneumothorax
Air leak diagnosed by chest x-ray
Measured: during first 3 days
pulmonary interstitial emphysema
Air leak diagnosed by x-ray
Measured: during first week
pulmonary hemorrhage
Measured: during first week
retinopathy of prematurity
Retinal disease diagnosed by indirect opthtalmoscopic exam
Measured: until 36 weeks corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress, NewbornStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Ergenekon, Gazi University
- Investigators
- Ebru N Ergenekon, MD, Principal investigator, Gazi University, Division of newborn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514331
- Sponsor's protocol ID
- 01/2011-68
- Status last verified
- Nov 2013
- First submitted
- 20 Dec 2011
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Ventilatory Parameters and Inflammatory Responses of Neonates Who Are Ventilated by Volume Guarantee Combined With Synchronized Intermittent Mandatory Ventilation or Pressure Support Ventilation
- ClinicalTrials.gov ID
- NCT01514331
- Acronym / sponsor ID
- 01/2011-68
- Keywords
- Ventilator Induced Lung Injury, Neonatal respiratory distress, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Jan 2012 (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.
The main purpose of this study is to investigate effects of SIMV+VG (synchronized intermittent mandatory ventilation+volume guarantee) or PSV+VG (pressure support ventilation+volume guarantee) ventilation on vital signs, patient - mechanical ventilation synchrony, ventilation parameters and inflammatory mediators in neonates.
Detailed description
Term or preterm neonates may need mechanical ventilation due to different etiologies. In all patients aim of mechanical ventilation is to promote pulmonary gas exchange, reduce the respiratory work of patient. Ideal mechanical ventilation must minimize pulmonary trauma with low inspiratory pressures that obtains adequate and constant tidal volumes. Ventilation associated pulmonary injury is an important subject that must be considered during mechanical ventilation. Atelectotrauma, volutrauma, barotrauma and biotrauma must be monitored. Volutrauma, barotrauma and oxygen toxicity cause cytokine increase that results in biotrauma. This parenchymal inflammation is a risk factor for chronic lung disease which is an important morbidity of ventilated neonates.
From past to present neonates were ventilated with different ventilation modes including IMV (Intermittent Mandatory Ventilation), SIMV, A/C (Assist Control Ventilation), PSV,HFV (High Frequency Ventilation). Both PSV and SIMV are patient trigger ventilation modes but SIMV is a time cycled and PSV is a flow cycled mode. In recent years hybrid techniques were developed to combine beneficial features of volume and pressure limited ventilation. In commercial ventilation devices these techniques have different names as volume guaranteed pressure limited ventilation (Drager Babylog 8000), pressure regulated volume controlled ventilation (Siemens servo 3000), volume guaranteed pressure support ventilation (VIP Bird Gold).
Since there is not a standard protocol for mechanical ventilation of neonates different countries and even different NICU's use different ventilation protocols.
Literature supports volume targetted ventilation to reduce barotrauma with low maximum inspiratory pressures and to reduce volutrauma with constant tidal volumes. When A/C+VG and SIMV+VG were compared in a crossover trial, more constant tidal volumes were obtained in A/C mode. Inflammatory cytokines have also been measured in different groups of patients with variable ventilatory management techniques. So far there has not been a randomized study published comparing VG+SIMV with VG+PSV in newborns with regards to tidal volume , peak inspiratory pressure variability,or inflammatory cytokines. Therefore in this study the investigators aimed to compare these two ventilation modes with regards to short term outcome.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSV+VG | Active comparator | Other: PSV+VG (pressure support ventilation+volume guarantee)Neonates who require mechanical ventilation and randomised to pressure support + volume guarantee (PSV+VG) mode |
| SIMV+VG | Active comparator | Other: SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee)Neonates who require mechanical ventilation and randomised to synchronised intermittant mandatory ventilation + volume guarantee (SIMV+VG) mode |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- neonates with respiratory distress who need mechanical ventilation
- gestational age less than or equal to 37 weeks
- neonates who need mechanical ventilation within first 24 hours
Key exclusion criteria (1 listed)
- neonates who need mechanical ventilation other than conventional ventilation
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 |
|---|---|---|
| SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee)Also: SIMV + VG mode of ventilationNeonates who need mechanical ventilation will be ventilated with SIMV+VG mode | Other | SIMV+VG |
| PSV+VG (pressure support ventilation+volume guarantee)Also: PSV+ VG mode of ventilationNeonates who need mechanical ventilation will be ventilated with PSV+VG | Other | PSV+VG |
Primary outcome
IL-1beta levels in tracheal aspirate material
Time frame: Baseline and 72 hours of mechanical ventilation
Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported
IL-6 level in tracheal aspirate
Time frame: Baseline and 72 hours of mechanical ventilation
Tracheal aspirate will be analyzed for IL6 level and the change from baseline will be reported
IL-8 in tracheal aspirate material
Time frame: Baseline and 72 hours of mechanical ventilation
Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported
IL-10 level in tracheal aspirate material
Time frame: Baseline and 72 hours of mechanical ventilation
Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported
TNF alfa in tracheal aspirate material
Time frame: Baseline and 72 hours of mechanical ventilation
Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported
tidal volume variability
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
variability in tidal volume measured with babyview program
peak inspiratory pressure variability
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
variability in peak inspiratory pressure measured with babyview program
respiratory rate variability
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
changes in respiratory rate, tacypnea rate
oxygen saturation variability
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
changes in oxygen saturation, desaturation rate, hyperoxy rate
lowest carbondioxide level (mmHg)
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
ratio of hypocarbic blood gases and least pCo2 level
highest carbondioxide level (mmHg)
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
ratio of hypercarbic blood gases and highest pCo2 level
lowest oxygen level (mmHg)
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
ratio of hypoxic blood gases and least pO2 level
highest oxygen level (mmHg)
Time frame: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier
ratio of hyperoxic blood gases and highest pO2 level
8 secondary outcomes
bronchopulmonary dysplasia
Time frame: 36 weeks corrected age
patent ductus arteriosus
Time frame: in the first week of post natal life of the patient
necrotizing enterocolitis
Time frame: 36 weeks corrected age
intraventricular hemorrhage
Time frame: during first week
pneumothorax
Time frame: during first 3 days
pulmonary interstitial emphysema
Time frame: during first week
pulmonary hemorrhage
Time frame: during first week
retinopathy of prematurity
Time frame: until 36 weeks corrected age
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 Nov 2013.
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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.
Ebru N Ergenekon, MD principal investigator
Gazi University, Division of newborn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee) and PSV+VG (pressure support ventilation+volume guarantee) in people with Respiratory Distress, Newborn and Ventilator Induced Lung Injury, run by Gazi University at 1 site in Turkey (Türkiye).
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 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 Nov 2013. 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 Turkey (Türkiye). 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?
IL-1beta levels in tracheal aspirate material (time frame: Baseline and 72 hours of mechanical ventilation). The study lists 13 primary outcomes in all. 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 Nov 2013.