Respiratory Distress SyndromeN_SIMVNCT01664832
Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?
A study testing S-nIMV in people with Respiratory Distress Syndrome, run by Prof. Dr. Helmut Hummler at 1 site in Germany.
Trial summary
The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants immediately after extubation when recovering from Respiratory distress syndrome (RDS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- S-nIMV
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm infants recovering from respiratory failure with the following criteria were eligible for this study.
- Gestational age <32 wks, those who are on invasive mechanical ventilation, recovering from RDS, and ready for extubation as judged by the clinical team.
- Informed consent available.
Who cannot join
- Infants with major congenital anomalies involving the CNS, lung (i.e. lung hypoplasia, active air leaks) or the heart (ASD, VSD allowed), or known neuromuscular disease.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Children's Hospital University of Ulm
Ulm, Baden-Wüttemberg, 89075
Helmut Hummler, Prof. Dr
About this study
The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants immediately after extubation when recovering from Respiratory distress syndrome (RDS).
Another objective is to examine the effects for synchronized non-invasive mechanical ventilation on gas exchange and cerebral oxygen saturation.
Read the detailed description
In this study the investigators plan to test the hypothesis that synchronized nasal IMV (S-NIMV) as compared to non-synchronized nasal IMV (NIMV) will decrease breathing effort in preterm infants immediately after extubation when recovery from RDS, as measured by phasic esophageal pressure deflection.
Furthermore, the investigators plan to evaluate the effects of synchronized NIMV on gas exchange and brain oxygenation, and to evaluate the reliability of a newly developed abdominal pressure sensor device for the S-NIMV mode in a newly designed commercially available ventilator device.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- S-nIMV
- Keywords
- Premature Infants, snychronized ventilation, non-invasive ventilation, RDS
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-nIMVDevice
Synchronization of nasal breaths to infant's own respiratory effort
| Study group | Role | What they receive |
|---|---|---|
| S-nIMV | Experimental | nIMV synchronized using abdominal pressure capsule sensor device Receives: Device: S-nIMV |
| nIMV | Placebo comparator | non-synchronized nasal intermittent mandatory ventilation group Receives: Device: S-nIMV |
What is being measured
The primary outcome is the main question the study is designed to answer.
phasic esophageal pressure deflection
Measured: 4 hours
Secondary outcomes (2)
Cerebral oxygen saturation
Measured: 4 hours
Arterial oxygen saturation
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Helmut Hummler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Helmut Hummler, University of Ulm
- Investigators
- Hummler Helmut, Prof. Dr, Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664832
- Sponsor's protocol ID
- ULMN_SIMV
- Acronym
- N_SIMV
- Status last verified
- Jun 2013
- First submitted
- 2 Aug 2012
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?
- ClinicalTrials.gov ID
- NCT01664832
- Acronym / sponsor ID
- N_SIMV / ULMN_SIMV
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Premature Infants, snychronized ventilation, non-invasive ventilation, RDS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Prof. Dr. Helmut HummlerUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2013 (estimated)
- First posted
- 14 Aug 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 purpose of this study is the examination of the hypothesis that synchronized nasal IMV as compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants immediately after extubation when recovering from Respiratory distress syndrome (RDS).
Another objective is to examine the effects for synchronized non-invasive mechanical ventilation on gas exchange and cerebral oxygen saturation.
Detailed description
In this study the investigators plan to test the hypothesis that synchronized nasal IMV (S-NIMV) as compared to non-synchronized nasal IMV (NIMV) will decrease breathing effort in preterm infants immediately after extubation when recovery from RDS, as measured by phasic esophageal pressure deflection.
Furthermore, the investigators plan to evaluate the effects of synchronized NIMV on gas exchange and brain oxygenation, and to evaluate the reliability of a newly developed abdominal pressure sensor device for the S-NIMV mode in a newly designed commercially available ventilator device.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-nIMV | Experimental | Device: S-nIMVnIMV synchronized using abdominal pressure capsule sensor device |
| nIMV | Placebo comparator | Device: S-nIMVnon-synchronized nasal intermittent mandatory ventilation group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preterm infants recovering from respiratory failure with the following criteria were eligible for this study.
- Gestational age <32 wks, those who are on invasive mechanical ventilation, recovering from RDS, and ready for extubation as judged by the clinical team.
- Informed consent available.
Key exclusion criteria (1 listed)
- Infants with major congenital anomalies involving the CNS, lung (i.e. lung hypoplasia, active air leaks) or the heart (ASD, VSD allowed), or known neuromuscular 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 |
|---|---|---|
| S-nIMVSynchronization of nasal breaths to infant's own respiratory effort | Device | S-nIMV, nIMV |
Primary outcome
phasic esophageal pressure deflection
Time frame: 4 hours
2 secondary outcomes
Cerebral oxygen saturation
Time frame: 4 hours
Arterial oxygen saturation
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 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.
Hummler Helmut, Prof. Dr principal investigator
University of Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-nIMV in people with Respiratory Distress Syndrome, run by Prof. Dr. Helmut Hummler at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 27 Jun 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 Germany. 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. Some participants in this study may receive a placebo. 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 Helmut Hummle, Prof. Dr. (0731-500-57168, helmut.hummler@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phasic esophageal pressure deflection (time frame: 4 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 27 Jun 2013; AzTrials last refreshed its copy on 30 Oct 2026.