Acute Respiratory FailureCHESTSIPPNCT05731024
Closed-loop Synchronization Versus Conventional Synchronization
A study testing Conventional synchronization settings with SPONT mode in people with Acute Respiratory Failure and Pediatric Respiratory Distress Syndrome, run by Dr. Behcet Uz Children's Hospital at 5 sites in Turkey (Türkiye).
Trial summary
A prior research indicated that asynchrony between the patient and ventilator occurred in 33 percent of 19,175 breaths, and was seen in every patient. The most prevalent kind of asynchrony was ineffective triggering (68%), followed by delayed termination (19%), double triggering (4%) and premature termination (3%). Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Acute Respiratory Failure, Pediatric Respiratory Distress Syndrome
- What is being tested?
- Conventional synchronization settings with SPONT mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- 6 Feb 2023to 30 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients older than 1 month and younger than18 years of age
- Hospitalized at the PICU with the intention of treatment with mechanical ventilation at least for the upcoming 3 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 PICU 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
- Not being able to obtain reference waveform
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Turkey (Türkiye)5 sites, 5 recruiting
- Recruiting
Aydin Obstetric and pediatrics Hospital
Aydin, 09020
ekin soydan, +905321003949, dr-ekinsoydan@hotmail.com
- Recruiting
Erzurum Regional Research and Training Hospital
Erzurum, 25180
Pinar Hepduman, MD, +905531501115, pnrhpdmn@gmail.com
- Recruiting
Erzurum Regional Research and Training Hospital
Erzurum, 25180
Sevgi Topal, MD, +905078645922
- Recruiting
Cam Sakura Research and Training Hospital
Istanbul, 34001
Mustafa Colak, MD, +905554180903, colakk@hotmail.com
- Recruiting
The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
Izmir, 35200
Ozlem Sandal, MD, +905067644688, drozlemsarac@hotmail.com
Gulhan Atakul, MD, gulhanatakul@gmail.com
About this study
Official title: Protocol for Comparing Closed-loop syncHronization vErsuS convenTional Synchronization In sPontaneously Breathing Pediatric Patients (CHESTSIPP) - a Randomized Cross-over Study
A prior research indicated that asynchrony between the patient and ventilator occurred in 33 percent of 19,175 breaths, and was seen in every patient. The most prevalent kind of asynchrony was ineffective triggering (68%), followed by delayed termination (19%), double triggering (4%) and premature termination (3%). Asynchrony between the patient and ventilator increased considerably with decreasing levels of peak inspiratory pressure, positive end-expiratory pressure, and set frequency.Despite this, more asynchrony categories exist, and there is no widely accepted categorization. Major asynchronies, however, include auto trigger, ineffective effort, and double trigger, while minor asynchronies include early/late cycle, trigger delay, and spontaneous breaths during a mandatory breath. This study aims to compare the safety and efficacy of a closed-loop synchronization controller with conventional control of synchronization during invasive mechanical ventilation of spontaneous breathing of pediatric patients in a pediatric intensive care unit (PICU).
- Being tested
- close-loop synchronization controller with SPONT mode, Conventional synchronization settings with SPONT mode
- Keywords
- Acute respiratory failure (ARF), Pediatric acute respiratory distress syndrome (PARDS), 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 SPONT modeDevice
One-hour period where the pressure support of spontaneous breath will be automatically titrated based on pressure and flow waveform analysis obtained from the patient.
Conventional synchronization settings with SPONT modeDevice
One-hour period where the pressure support of spontaneous breath will be manually set.
| Study group | Role | What they receive |
|---|---|---|
| Close-loop synchronization controller | Experimental | One-hour period where the pressure support of spontaneous effort will be automatically titrated based on pressure and flow waveform analysis obtained from the patient during SPONT mode. Receives: Device: close-loop synchronization controller with SPONT mode |
| Conventional | Active comparator | One-hour period where the synchronization of pressure support of patient effort during SPONT mode will be manually set. Receives: Device: Conventional synchronization settings with SPONT mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchrony Index
[(major asynchronies+minor asynchronies )/(total number of breaths + ineffective efforts)]x100
Measured: 1 hour
Secondary outcomes (6)
Major asynchronies
[(major asynchronies)/(total number of breaths + ineffective efforts)]x100
Measured: 1 hour
Minor asynchronies
[(minor asynchronies)/(total number of breaths + ineffective efforts)]x100
Measured: 1 hour
Comfort Behavioral Score
The Comfort Behavioral Scale yields points based on scores obtained from the Comfort B Scale. Scores below 10 indicate that the patient may be over-sedated, while scores between 12 and 17 suggest that the patient is adequately comfortable. Scores above 17 may suggest that the patient is experiencing inadequate sedation
Measured: 1 hour
Leak
Percentage of leak around endotrachel tube (%)
Measured: 1 hour
Mean SpO2
Mean peripheral oxygen saturation (%)
Measured: 1 hour
Mean EtCO2
Mean end-tidal carbon dioxide (mm Hg)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start6 Feb 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Medical AG
- Responsible party
- Principal investigator, Hasan ağın, Dr. Behcet Uz Children's Hospital
- Investigators
- Hasan Agin, Professor, Principal investigator, Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731024
- Sponsor's protocol ID
- 02019336
- Acronym
- CHESTSIPP
- Status last verified
- Mar 2025
- First submitted
- 3 Feb 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Dijk J, Blokpoel RGT, Abu-Sultaneh S, Newth CJL, Khemani RG, Kneyber MCJ. Clinical Challenges in Pediatric Ventilation Liberation: A Meta-Narrative Review. Pediatr Crit Care Med. 2022 Dec 1;23(12):999-1008. doi: 10.1097/PCC.0000000000003025. Epub 2022 Jul 14.
PubMed 35830707Emeriaud G, Newth CJ; Pediatric Acute Lung Injury Consensus Conference Group. Monitoring of children with pediatric acute respiratory distress syndrome: proceedings from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5 Suppl 1):S86-101. doi: 10.1097/PCC.0000000000000436.
PubMed 26035368Blokpoel RG, Burgerhof JG, Markhorst DG, Kneyber MC. Patient-Ventilator Asynchrony During Assisted Ventilation in Children. Pediatr Crit Care Med. 2016 May;17(5):e204-11. doi: 10.1097/PCC.0000000000000669.
PubMed 26914624Colleti J Jr, Brunow de Carvalho W. Patient-Ventilator Asynchrony During Assisted Ventilation in Children: The Time to Rethink Our Knowledge. Pediatr Crit Care Med. 2016 Aug;17(8):811. doi: 10.1097/PCC.0000000000000793. No abstract available.
PubMed 27500623Vignaux L, Grazioli S, Piquilloud L, Bochaton N, Karam O, Jaecklin T, Levy-Jamet Y, Tourneux P, Jolliet P, Rimensberger PC. Optimizing patient-ventilator synchrony during invasive ventilator assist in children and infants remains a difficult task*. Pediatr Crit Care Med. 2013 Sep;14(7):e316-25. doi: 10.1097/PCC.0b013e31828a8606.
PubMed 23842584Blokpoel RGT, Burgerhof JGM, Markhorst DG, Kneyber MCJ. Trends in Pediatric Patient-Ventilator Asynchrony During Invasive Mechanical Ventilation. Pediatr Crit Care Med. 2021 Nov 1;22(11):993-997. doi: 10.1097/PCC.0000000000002788.
PubMed 34054119Ceylan G, Sarac O, Atakul G, Soydan E, Colak M, Topal S, Hepduman P, Novotni D, Meyer J, Karaaslan U, Revely JP, Agin H. Closed-loop synchronization versus conventional synchronization in spontaneously breathing pediatric patients (CHESTSIPP) - a randomized controlled cross-over study. Front Med (Lausanne). 2026 Mar 25;13:1745939. doi: 10.3389/fmed.2026.1745939. eCollection 2026.
PubMed 41958566
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Comparing Closed-loop syncHronization vErsuS convenTional Synchronization In sPontaneously Breathing Pediatric Patients (CHESTSIPP) - a Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT05731024
- Acronym / sponsor ID
- CHESTSIPP / 02019336
- Keywords
- Acute respiratory failure (ARF), Pediatric acute respiratory distress syndrome (PARDS), Closed-loop, synchronization, patient ventilator asynchrony
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Collaborators
- Hamilton Medical AG
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 16 Feb 2023 (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.
A prior research indicated that asynchrony between the patient and ventilator occurred in 33 percent of 19,175 breaths, and was seen in every patient. The most prevalent kind of asynchrony was ineffective triggering (68%), followed by delayed termination (19%), double triggering (4%) and premature termination (3%). Asynchrony between the patient and ventilator increased considerably with decreasing levels of peak inspiratory pressure, positive end-expiratory pressure, and set frequency.Despite this, more asynchrony categories exist, and there is no widely accepted categorization. Major asynchronies, however, include auto trigger, ineffective effort, and double trigger, while minor asynchronies include early/late cycle, trigger delay, and spontaneous breaths during a mandatory breath. This study aims to compare the safety and efficacy of a closed-loop synchronization controller with conventional control of synchronization during invasive mechanical ventilation of spontaneous breathing of pediatric patients in a pediatric intensive care unit (PICU).
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 | Device: close-loop synchronization controller with SPONT modeOne-hour period where the pressure support of spontaneous effort will be automatically titrated based on pressure and flow waveform analysis obtained from the patient during SPONT mode. |
| Conventional | Active comparator | Device: Conventional synchronization settings with SPONT modeOne-hour period where the synchronization of pressure support of patient effort during SPONT mode will be manually set. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric patients older than 1 month and younger than18 years of age
- Hospitalized at the PICU with the intention of treatment with mechanical ventilation at least for the upcoming 3 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 (7 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 PICU 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 SPONT modeOne-hour period where the pressure support of spontaneous breath will be automatically titrated based on pressure and flow waveform analysis obtained from the patient. | Device | Close-loop synchronization controller |
| Conventional synchronization settings with SPONT modeOne-hour period where the pressure support of spontaneous breath will be manually set. | Device | Conventional |
Primary outcome
Asynchrony Index
Time frame: 1 hour
[(major asynchronies+minor asynchronies )/(total number of breaths + ineffective efforts)]x100
6 secondary outcomes
Major asynchronies
Time frame: 1 hour
Minor asynchronies
Time frame: 1 hour
Comfort Behavioral Score
Time frame: 1 hour
Leak
Time frame: 1 hour
Mean SpO2
Time frame: 1 hour
Mean EtCO2
Time frame: 1 hour
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 19 Mar 2025.
- Background: PubMed 35830707van Dijk J, Blokpoel RGT, Abu-Sultaneh S, Newth CJL, Khemani RG, Kneyber MCJ. Clinical Challenges in Pediatric Ventilation Liberation: A Meta-Narrative Review. Pediatr Crit Care Med. 2022 Dec 1;23(12):999-1008. doi: 10.1097/PCC.0000000000003025. Epub 2022 Jul 14.
- Background: PubMed 26035368Emeriaud G, Newth CJ; Pediatric Acute Lung Injury Consensus Conference Group. Monitoring of children with pediatric acute respiratory distress syndrome: proceedings from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5 Suppl 1):S86-101. doi: 10.1097/PCC.0000000000000436.
- Background: PubMed 26914624Blokpoel RG, Burgerhof JG, Markhorst DG, Kneyber MC. Patient-Ventilator Asynchrony During Assisted Ventilation in Children. Pediatr Crit Care Med. 2016 May;17(5):e204-11. doi: 10.1097/PCC.0000000000000669.
- Background: PubMed 27500623Colleti J Jr, Brunow de Carvalho W. Patient-Ventilator Asynchrony During Assisted Ventilation in Children: The Time to Rethink Our Knowledge. Pediatr Crit Care Med. 2016 Aug;17(8):811. doi: 10.1097/PCC.0000000000000793. No abstract available.
- Background: PubMed 23842584Vignaux L, Grazioli S, Piquilloud L, Bochaton N, Karam O, Jaecklin T, Levy-Jamet Y, Tourneux P, Jolliet P, Rimensberger PC. Optimizing patient-ventilator synchrony during invasive ventilator assist in children and infants remains a difficult task*. Pediatr Crit Care Med. 2013 Sep;14(7):e316-25. doi: 10.1097/PCC.0b013e31828a8606.
- Background: PubMed 34054119Blokpoel RGT, Burgerhof JGM, Markhorst DG, Kneyber MCJ. Trends in Pediatric Patient-Ventilator Asynchrony During Invasive Mechanical Ventilation. Pediatr Crit Care Med. 2021 Nov 1;22(11):993-997. doi: 10.1097/PCC.0000000000002788.
- Derived from this study: PubMed 41958566Ceylan G, Sarac O, Atakul G, Soydan E, Colak M, Topal S, Hepduman P, Novotni D, Meyer J, Karaaslan U, Revely JP, Agin H. Closed-loop synchronization versus conventional synchronization in spontaneously breathing pediatric patients (CHESTSIPP) - a randomized controlled cross-over study. Front Med (Lausanne). 2026 Mar 25;13:1745939. doi: 10.3389/fmed.2026.1745939. eCollection 2026.
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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.
Hasan Agin, Professor principal investigator
Behcet Uz Children's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional synchronization settings with SPONT mode in people with Acute Respiratory Failure and Pediatric Respiratory Distress Syndrome, run by Dr. Behcet Uz Children's Hospital at 5 sites 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 7 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 19 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 5 sites 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 Hasan Agin, Professor (+905362013162, hasanagin@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: 1 hour). 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 NCT05731024, which also lists 7 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 19 Mar 2025.