Acute Respiratory FailureCHESTSPANNCT06357780
Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive ventilationPatients
A study testing Conventional in people with Acute Respiratory Failure and Acute Respiratory Distress Syndrome, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study is a multicentric prospective randomised cross-over study. It evaluates the compatibility of patients with the device without altering the routine treatment applied. During this evaluation, either the clinician-adjusted values on the device or the standard pre-set values are used to obtain hourly and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Acute Respiratory Distress Syndrome, Chronic Respiratory Failure
- What is being tested?
- Conventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients older than 18 years of age
- Hospitalized at the ICU or emergency department with the intention of treatment with Noninvasive ventilation at least for the upcoming 2 hours with spontaneous breathing activity
- Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation
Who cannot join
- Formalized ethical decision to withhold or withdraw life support
- Patient included in another interventional research study under consent
- Patient already enrolled in the present study in a previous episode of respiratory failure
- Pregnant woman
- Patients deemed at high risk for the need of transportation from an intensive care unit or emergency department to another ward, diagnostic unit or any other hospital
- Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine > 1 mg/h
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- Not being able to obtain reference waveforms due to technical or medical problems
- Vulnerable population
- Increase or decrease of ventilatory support either in pressures, fraction of inspired oxygen or mode of ventilation during study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tuba Dogan, MD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr.Suat Seren Chest Diseasees Hospital
Izmir, 35230
Cenk Kirakli, professor
About this study
Official title: Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive Ventilation Patients (CHEST-SPAN) - a Randomized Cross-over Trial
The study is a multicentric prospective randomised cross-over study. It evaluates the compatibility of patients with the device without altering the routine treatment applied. During this evaluation, either the clinician-adjusted values on the device or the standard pre-set values are used to obtain hourly and 30-minute PVA (Patient Ventilator Asynchrony) recordings. These recordings will be analysed offline to identify the settings used and to compare the hourly and 30-minute PVA (Patient Ventilator Asynchrony) values when synchronisation is automatically set. The relationships and differences between these values will be analysed. For this purpose, the IntelliSync+ option, already available on the device, will be used. This software continuously analyses waveform signals at least a hundred times per second. This allows for the immediate detection of patient efforts and the initiation of inspiration and expiration in real time, thereby replacing traditional trigger settings for inspiration and expiration. If the patient is already synchronised with this option, it will then be possible to switch to traditional synchronisation settings for comparison. Statistical analyses will be conducted using SPSS 24.0, JASP (Just Another Statistical Programme), Jamovi ( fork of JASP), or R software. Initially, all numerical and categorical data will be evaluated using descriptive statistical methods. The distributions of numerical variables will be examined using visual (histograms and probability plots) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). Mean/SD (standard deviation) or median/interquartile range (IQR) will be used as measures of distribution. For comparing numerical data that follows a normal distribution, the Student-t test will be used, and for non-normally distributed data, the Mann-Whitney U or Wilcoxon signed-rank tests will be employed. PVA (Patient Ventilator Asynchrony) values will be statistically compared. For the analysis of categorical data, the Chi-Square test will be applied. Bayesian analysis may also be used as necessary during the writing of the study. The results obtained will be interpreted and reported by the researchers. Results with a "p" value below 0.05 will be considered statistically significant.
- Conditions
- Acute Respiratory Failure, Acute Respiratory Distress Syndrome, Chronic Respiratory Failure
- Being tested
- close-loop synchronization controller with spontaneous mode, Conventional
- Keywords
- Acute respiratory failure (ARF), noninvasive ventilation, Closed-loop, synchronization, patient ventilator asynchrony
- Medical subject headings
- Respiratory Distress Syndrome, Patient-Ventilator Asynchrony
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
close-loop synchronization controller with spontaneous modeOther
30 minutes period where the pressure support of spontaneous effort will be automatically titrated based on pressure and flow waveform analysis obtained from the patient during NIV mode.
ConventionalOther
30 minutes period where the synchronization of pressure support of patient effort during NIV mode will be manually set.
| Study group | Role | What they receive |
|---|---|---|
| Close-loop synchronization controller | Experimental | 30 minutes period where the pressure support of spontaneous effort will be automatically titrated based on pressure and flow waveform analysis obtained from the patient during NIV mode. Receives: Other: close-loop synchronization controller with spontaneous mode |
| Conventional | Active comparator | 30 minutes period where the synchronization of pressure support of patient effort during NIV mode will be manually set. Receives: Other: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchrony Index
[(detectable asynchronies )/(total number of breaths + ineffective efforts)]x100
Measured: 30 minutes
Secondary outcomes (3)
Major Asynchrony index
[(major asynchronies)/(total number of breaths + ineffective efforts)]x100
Measured: 30 minutes
Minor Asynchrony index
[(minor asynchronies)/(total number of breaths + ineffective efforts)]x100
Measured: 30 minutes
Dyspnea Scale
Patient subjective dyspnea scale
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start8 Apr 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ramazan Guven, Associate professor, Principal investigator, Basaksehir Cam Sakura city Hospital, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357780
- Sponsor's protocol ID
- 240396837
- Acronym
- CHESTSPAN
- Status last verified
- Mar 2025
- First submitted
- 5 Apr 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1.
PubMed 16896854Longhini F, Bruni A, Garofalo E, Tutino S, Vetrugno L, Navalesi P, De Robertis E, Cammarota G. Monitoring the patient-ventilator asynchrony during non-invasive ventilation. Front Med (Lausanne). 2023 Jan 19;9:1119924. doi: 10.3389/fmed.2022.1119924. eCollection 2022.
PubMed 36743668Itagaki T, Akimoto Y, Nakano Y, Ueno Y, Ishihara M, Tane N, Tsunano Y, Oto J. Relationships between double cycling and inspiratory effort with diaphragm thickness during the early phase of mechanical ventilation: A prospective observational study. PLoS One. 2022 Aug 17;17(8):e0273173. doi: 10.1371/journal.pone.0273173. eCollection 2022.
PubMed 35976965Xu Z, Sheng D, Jiao K, Zhang C, Hao J, Ma D. Factors affecting abnormal triggering with non-invasive ventilators: A before-and-after study. Clin Respir J. 2022 Jun;16(6):450-459. doi: 10.1111/crj.13497. Epub 2022 May 31.
PubMed 35642081Mojoli F, Pozzi M, Orlando A, Bianchi IM, Arisi E, Iotti GA, Braschi A, Brochard L. Timing of inspiratory muscle activity detected from airway pressure and flow during pressure support ventilation: the waveform method. Crit Care. 2022 Jan 30;26(1):32. doi: 10.1186/s13054-022-03895-4.
PubMed 35094707Guven R, Kirakli C, Revely JP, Colak M, Dogan T, Novotni D, Aurucci V, Altug E, Yildirim S, Sunecli O, Agin H, Ceylan G. Closed-loop versus conventional synchronization in spontaneously breathing adult patients- a randomized controlled study. J Crit Care. 2026 Aug 14;97:155705. doi: 10.1016/j.jcrc.2026.155705. Online ahead of print.
PubMed 42600333
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive Ventilation Patients (CHEST-SPAN) - a Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT06357780
- Acronym / sponsor ID
- CHESTSPAN / 240396837
- Conditions
- Acute Respiratory Failure, Acute Respiratory Distress Syndrome, Chronic Respiratory Failure
- Keywords
- Acute respiratory failure (ARF), noninvasive ventilation, Closed-loop, synchronization, patient ventilator asynchrony
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Apr 2024 (actual)
- 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 study is a multicentric prospective randomised cross-over study. It evaluates the compatibility of patients with the device without altering the routine treatment applied. During this evaluation, either the clinician-adjusted values on the device or the standard pre-set values are used to obtain hourly and 30-minute PVA (Patient Ventilator Asynchrony) recordings. These recordings will be analysed offline to identify the settings used and to compare the hourly and 30-minute PVA (Patient Ventilator Asynchrony) values when synchronisation is automatically set. The relationships and differences between these values will be analysed. For this purpose, the IntelliSync+ option, already available on the device, will be used. This software continuously analyses waveform signals at least a hundred times per second. This allows for the immediate detection of patient efforts and the initiation of inspiration and expiration in real time, thereby replacing traditional trigger settings for inspiration and expiration. If the patient is already synchronised with this option, it will then be possible to switch to traditional synchronisation settings for comparison. Statistical analyses will be conducted using SPSS 24.0, JASP (Just Another Statistical Programme), Jamovi ( fork of JASP), or R software. Initially, all numerical and categorical data will be evaluated using descriptive statistical methods. The distributions of numerical variables will be examined using visual (histograms and probability plots) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). Mean/SD (standard deviation) or median/interquartile range (IQR) will be used as measures of distribution. For comparing numerical data that follows a normal distribution, the Student-t test will be used, and for non-normally distributed data, the Mann-Whitney U or Wilcoxon signed-rank tests will be employed. PVA (Patient Ventilator Asynchrony) values will be statistically compared. For the analysis of categorical data, the Chi-Square test will be applied. Bayesian analysis may also be used as necessary during the writing of the study. The results obtained will be interpreted and reported by the researchers. Results with a "p" value below 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Close-loop synchronization controller | Experimental | Other: close-loop synchronization controller with spontaneous mode30 minutes period where the pressure support of spontaneous effort will be automatically titrated based on pressure and flow waveform analysis obtained from the patient during NIV mode. |
| Conventional | Active comparator | Other: Conventional30 minutes period where the synchronization of pressure support of patient effort during NIV mode will be manually set. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients older than 18 years of age
- Hospitalized at the ICU or emergency department with the intention of treatment with Noninvasive ventilation at least for the upcoming 2 hours with spontaneous breathing activity
- Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation
Key exclusion criteria (9 listed)
- Formalized ethical decision to withhold or withdraw life support
- Patient included in another interventional research study under consent
- Patient already enrolled in the present study in a previous episode of respiratory failure
- Pregnant woman
- Patients deemed at high risk for the need of transportation from an intensive care unit or emergency department to another ward, diagnostic unit or any other hospital
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 |
|---|---|---|
| close-loop synchronization controller with spontaneous mode30 minutes period where the pressure support of spontaneous effort will be automatically titrated based on pressure and flow waveform analysis obtained from the patient during NIV mode. | Other | Close-loop synchronization controller |
| Conventional30 minutes period where the synchronization of pressure support of patient effort during NIV mode will be manually set. | Other | Conventional |
Primary outcome
Asynchrony Index
Time frame: 30 minutes
[(detectable asynchronies )/(total number of breaths + ineffective efforts)]x100
3 secondary outcomes
Major Asynchrony index
Time frame: 30 minutes
Minor Asynchrony index
Time frame: 30 minutes
Dyspnea Scale
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Background: PubMed 16896854Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1.
- Background: PubMed 36743668Longhini F, Bruni A, Garofalo E, Tutino S, Vetrugno L, Navalesi P, De Robertis E, Cammarota G. Monitoring the patient-ventilator asynchrony during non-invasive ventilation. Front Med (Lausanne). 2023 Jan 19;9:1119924. doi: 10.3389/fmed.2022.1119924. eCollection 2022.
- Background: PubMed 35976965Itagaki T, Akimoto Y, Nakano Y, Ueno Y, Ishihara M, Tane N, Tsunano Y, Oto J. Relationships between double cycling and inspiratory effort with diaphragm thickness during the early phase of mechanical ventilation: A prospective observational study. PLoS One. 2022 Aug 17;17(8):e0273173. doi: 10.1371/journal.pone.0273173. eCollection 2022.
- Background: PubMed 35642081Xu Z, Sheng D, Jiao K, Zhang C, Hao J, Ma D. Factors affecting abnormal triggering with non-invasive ventilators: A before-and-after study. Clin Respir J. 2022 Jun;16(6):450-459. doi: 10.1111/crj.13497. Epub 2022 May 31.
- Background: PubMed 35094707Mojoli F, Pozzi M, Orlando A, Bianchi IM, Arisi E, Iotti GA, Braschi A, Brochard L. Timing of inspiratory muscle activity detected from airway pressure and flow during pressure support ventilation: the waveform method. Crit Care. 2022 Jan 30;26(1):32. doi: 10.1186/s13054-022-03895-4.
- Derived from this study: PubMed 42600333Guven R, Kirakli C, Revely JP, Colak M, Dogan T, Novotni D, Aurucci V, Altug E, Yildirim S, Sunecli O, Agin H, Ceylan G. Closed-loop versus conventional synchronization in spontaneously breathing adult patients- a randomized controlled study. J Crit Care. 2026 Aug 14;97:155705. doi: 10.1016/j.jcrc.2026.155705. Online ahead of print.
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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.
Tuba Dogan, MD contact
Ramazan Guven, Associate professor principal investigator
Basaksehir Cam Sakura city Hospital, Istanbul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional in people with Acute Respiratory Failure and Acute Respiratory Distress Syndrome, run by Başakşehir Çam & Sakura City Hospital 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 9 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: looking for participants now, as of the sponsor's last update on 26 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramazan Guven, Associate professor (05324935995, drramazanguven@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asynchrony Index (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06357780, which also lists 6 linked publications.
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 26 Mar 2025.