Apnea, HypoxiaNCT02774408
Effects of Automated Adjustment of Inspired Oxygen With Combined Adaptive Mechanical Backup Ventilation as Compared to Automated Oxygen Adjustment Alone in Preterm Infants With Intermittent Hypoxemic Events During Non-invasive Ventilatory Support
A study testing Saturation sensitive backup ventilation in people with Apnea, Hypoxia, run by University of Ulm.
Trial summary
In this 2-phase cross-over study the investigators test the hypothesis that automated adjustment of the inspired oxygen with the combined use of synchronized noninvasive SpO2-sensitive and apnea-sensitive backup-ventilation (S-NIPPV) increases the time within the intended oxygen saturation range as compared to… Read more about this study
- Who is it for?
- Ages 96 hours to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Apnea, Hypoxia
- What is being tested?
- Saturation sensitive backup ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jul 2016
- 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 96 hours to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- postmenstrual age <34 wks GA at study time (<32 wks GA at birth)
- on nasal/nasopharyngeal CPAP or nasal IMV / IPPV
- at least 4 desaturations (SpO2 <80%) during an 8 hour period within the 24h before the study using a standard pulse oximeter incorporated in the NICU (Masimo SET, Irvine, CA, averaging time 8 sec; delay 10s)
- informed consent obtained from the parents or legal guardian
Who cannot join
- postnatal age <96h (to exclude rapidly changing conditions during the early phase of RDS and to avoid handling of the infant during the critical period for IVH)
- congenital cyanotic heart disease
- no decision for full treatment support
- Average FiO2 during the last 24h bevor the active study phase >0.60 (too sick for non-invasive ventilator support)
- Congenital malformations of the lung or the diaphragm (i.e. diaphragmatic hernia, congenital cystic lung diseases...)
- Clinical evidence for seizures
- Ongoing Sepsis with hemodynamic compromise (defined as a CrP > 20mg/l or positive blood culture (for sepsis), and requirement of catecholamines (for hemodynamic compromise))
- Need of blood-transfusion during study time
About this study
In this 2-phase cross-over study the investigators test the hypothesis that automated adjustment of the inspired oxygen with the combined use of synchronized noninvasive SpO2-sensitive and apnea-sensitive backup-ventilation (S-NIPPV) increases the time within the intended oxygen saturation range as compared to automated FiO2 adjustment alone.
Read the detailed description
This study will be a randomized-controlled clinical study with cross-over design of two treatment phases of 24h duration each (1. Automated FiO2-adjustment (SPO2C), 2. combined use of automated FiO2-adjustment and SpO2-sensitive/apnea-sensitive S-NIPPV (SPO2C + BU), see Figures 1 and 2). The investigators will study two patient groups of premature infants depending on the type of respiratory support at study time: One group, where the infants are on CPAP at study time, and another group of preterm infants who are already supported by nasopharyngeal IPPV at study time. Both studies will be sufficiently powered to show a significant treatment effect if it is present. Study infants will be recruited in the neonatal ICU of the children's hospital, University of Ulm and the neonatal ICU, University of Munich. Both NICU team have participated previously in clinical trials investigated new modes of mechanical ventilation using automated ventilation adjustment in the target population.
Randomization of the sequence of the two study phases will be carried out using sealed envelopes. Infants will be changed to a specific ventilator device approved for clinical use in neonates in Germany (Sophie®-Respirator, Stephan Medizintechnik GmbH, Gackenbach, Germany), which is capable to automatically adjust the FiO2 (called "SPO2C") and to apply noninvasive backup-ventilation (using a noninvasive trigger device (S-NIPPV) or non-synchronized nasal IPPV (NIPPV) based on readings of an incorporated SpO2 monitoring device (Masimo® Radical 7, averaging time 2 sec). Synchronization of NIPPV and detection of apnea is achieved by using the Graseby capsule (Stephan, Vio Healthcare Ltd, Ref. 103560103), which will be secured onto the anterior abdominal wall near to the right costal margin.
Infants on CPAP (first group) will be exposed to the first study phase (SPO2C, or SPO2C + BU, Figure 1) for 24h and then will be switched to the alternate mode for 24h each. Infants, who are already on nasal IPPV (SIPPV or NIPPV) as chosen by the clinical team will be exposed to NIPPV with a standardized inflation rate of 40 breaths/min (nonsynchronized, because this seems to be the current standard of care according to the available literature) and SPO2C, or to SPO2C plus synchronized BU (starting with a rate of 80 inflations/min with stepwise weaning) and then will be switched to the alternate mode for 24h each.
- Conditions
- Apnea, Hypoxia
- Being tested
- Saturation sensitive backup ventilation
- Keywords
- backup ventilation, preterm infants, functional residual capacity, chronic lung disease
- Medical subject headings
- Apnea, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saturation sensitive backup ventilationDevice
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Other | Infants on CPAP will receive backup breafs whenever the SpO2 <88 % along with
automated FiO2 controller. In the control period they will receive automated FiO2
alone Receives: Device: Saturation sensitive backup ventilation |
| NIMV/NIPPV | Other | Infants on NIMV NIPPV will receive an increase in the backup rate to 2 times the rate
of the backup triggered by apnoe (apnoe time 5s), whenever the SpO2 under 88%
( max rate 100/min) in the reference period as compared to baseline (automated FiO2
- control + unchanged SIPPV settings) Receives: Device: Saturation sensitive backup ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the total duration of time with an arterial oxygen saturation as measured by pulse oxymetry (percentage of the total recording time) within the target range (88-95%).
Measured: 48 hours
Secondary outcomes (8)
the number of episodes with an SpO2 <80%
Measured: 48 hours
The number of extended/very long episodes outside the SpO2 target range (defined as episodes with a duration of more than 1 minute/3 minutes)
Measured: 48 hours
Mean SpO2.
Measured: 48 hours
Variability of SpO2 (coefficient of variation)
Measured: 48 hours
Mean FiO2 during the study time
Measured: 48 hours
The workload for the medical staff as measured by the number of manual adjustments of FiO2 because of episodes of hyperoxemia
Measured: 48 hours
The workload for the medical staff as measured by the number of manual adjustments of FiO2 because of episodes of hypoxemia.
Measured: 48 hours
Tissue oxygenation measurement (measured with near infrared spectrometry) of different organs (kidney, brain, muscle )
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea, HypoxiaStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. von Hauner Children's Hospital
- Responsible party
- Principal investigator, Prof. Dr. Helmut Hummler, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774408
- Sponsor's protocol ID
- FiO2 Backup
- Status last verified
- May 2016
- First submitted
- 24 Mar 2016
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Automated Adjustment of Inspired Oxygen With Combined Adaptive Mechanical Backup Ventilation as Compared to Automated Oxygen Adjustment Alone in Preterm Infants With Intermittent Hypoxemic Events During Non-invasive Ventilatory Support
- ClinicalTrials.gov ID
- NCT02774408
- Acronym / sponsor ID
- FiO2 Backup
- Conditions
- Apnea, Hypoxia
- Keywords
- backup ventilation, preterm infants, functional residual capacity, chronic lung disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Dr. von Hauner Children's Hospital
- Study start
- Jun 2016
- Primary completion
- Jul 2016 (estimated)
- First posted
- 17 May 2016 (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.
In this 2-phase cross-over study the investigators test the hypothesis that automated adjustment of the inspired oxygen with the combined use of synchronized noninvasive SpO2-sensitive and apnea-sensitive backup-ventilation (S-NIPPV) increases the time within the intended oxygen saturation range as compared to automated FiO2 adjustment alone.
Detailed description
This study will be a randomized-controlled clinical study with cross-over design of two treatment phases of 24h duration each (1. Automated FiO2-adjustment (SPO2C), 2. combined use of automated FiO2-adjustment and SpO2-sensitive/apnea-sensitive S-NIPPV (SPO2C + BU), see Figures 1 and 2). The investigators will study two patient groups of premature infants depending on the type of respiratory support at study time: One group, where the infants are on CPAP at study time, and another group of preterm infants who are already supported by nasopharyngeal IPPV at study time. Both studies will be sufficiently powered to show a significant treatment effect if it is present. Study infants will be recruited in the neonatal ICU of the children's hospital, University of Ulm and the neonatal ICU, University of Munich. Both NICU team have participated previously in clinical trials investigated new modes of mechanical ventilation using automated ventilation adjustment in the target population.
Randomization of the sequence of the two study phases will be carried out using sealed envelopes. Infants will be changed to a specific ventilator device approved for clinical use in neonates in Germany (Sophie®-Respirator, Stephan Medizintechnik GmbH, Gackenbach, Germany), which is capable to automatically adjust the FiO2 (called "SPO2C") and to apply noninvasive backup-ventilation (using a noninvasive trigger device (S-NIPPV) or non-synchronized nasal IPPV (NIPPV) based on readings of an incorporated SpO2 monitoring device (Masimo® Radical 7, averaging time 2 sec). Synchronization of NIPPV and detection of apnea is achieved by using the Graseby capsule (Stephan, Vio Healthcare Ltd, Ref. 103560103), which will be secured onto the anterior abdominal wall near to the right costal margin.
Infants on CPAP (first group) will be exposed to the first study phase (SPO2C, or SPO2C + BU, Figure 1) for 24h and then will be switched to the alternate mode for 24h each. Infants, who are already on nasal IPPV (SIPPV or NIPPV) as chosen by the clinical team will be exposed to NIPPV with a standardized inflation rate of 40 breaths/min (nonsynchronized, because this seems to be the current standard of care according to the available literature) and SPO2C, or to SPO2C plus synchronized BU (starting with a rate of 80 inflations/min with stepwise weaning) and then will be switched to the alternate mode for 24h each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Other | Device: Saturation sensitive backup ventilationInfants on CPAP will receive backup breafs whenever the SpO2 <88 % along with automated FiO2 controller. In the control period they will receive automated FiO2 alone |
| NIMV/NIPPV | Other | Device: Saturation sensitive backup ventilationInfants on NIMV NIPPV will receive an increase in the backup rate to 2 times the rate of the backup triggered by apnoe (apnoe time 5s), whenever the SpO2 under 88% ( max rate 100/min) in the reference period as compared to baseline (automated FiO2 - control + unchanged SIPPV settings) |
Who may qualify
- Ages
- 96 hours to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- postmenstrual age <34 wks GA at study time (<32 wks GA at birth)
- on nasal/nasopharyngeal CPAP or nasal IMV / IPPV
- at least 4 desaturations (SpO2 <80%) during an 8 hour period within the 24h before the study using a standard pulse oximeter incorporated in the NICU (Masimo SET, Irvine, CA, averaging time 8 sec; delay 10s)
- informed consent obtained from the parents or legal guardian
Key exclusion criteria (8 listed)
- postnatal age <96h (to exclude rapidly changing conditions during the early phase of RDS and to avoid handling of the infant during the critical period for IVH)
- congenital cyanotic heart disease
- no decision for full treatment support
- Average FiO2 during the last 24h bevor the active study phase >0.60 (too sick for non-invasive ventilator support)
- Congenital malformations of the lung or the diaphragm (i.e. diaphragmatic hernia, congenital cystic lung diseases...)
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 |
|---|---|---|
| Saturation sensitive backup ventilation | Device | CPAP, NIMV/NIPPV |
Primary outcome
The primary outcome measure is the total duration of time with an arterial oxygen saturation as measured by pulse oxymetry (percentage of the total recording time) within the target range (88-95%).
Time frame: 48 hours
8 secondary outcomes
the number of episodes with an SpO2 <80%
Time frame: 48 hours
The number of extended/very long episodes outside the SpO2 target range (defined as episodes with a duration of more than 1 minute/3 minutes)
Time frame: 48 hours
Mean SpO2.
Time frame: 48 hours
Variability of SpO2 (coefficient of variation)
Time frame: 48 hours
Mean FiO2 during the study time
Time frame: 48 hours
The workload for the medical staff as measured by the number of manual adjustments of FiO2 because of episodes of hyperoxemia
Time frame: 48 hours
The workload for the medical staff as measured by the number of manual adjustments of FiO2 because of episodes of hypoxemia.
Time frame: 48 hours
Tissue oxygenation measurement (measured with near infrared spectrometry) of different organs (kidney, brain, muscle )
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Saturation sensitive backup ventilation in people with Apnea, Hypoxia, run by University of Ulm.
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 4 inclusion and 8 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 primary outcome measure is the total duration of time with an arterial oxygen saturation as measured by pulse oxymetry (percentage of the total recording time) within the target range (88-95%). (time frame: 48 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 17 May 2016.