Mechanical Ventilation Complicationi-SyncNCT06295237
Automatic Adjustment for Asynchronies During Mechanical Ventilation
A study testing Intellisync+ in people with Mechanical Ventilation Complication, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Asynchronies between the patient and the artificial ventilator are a frequent problem. They may cause altered sleep, ventilator-induced lung injury, prolong length of ICU stay, cause neuro-psycologic complications and increase mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Intellisync+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2024to 15 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >17 years
- Partial ventilatory support ("SPONT" mode) connected to Hamilton C1 model, irrespective of chronic restrictive or obstructive lung disease, categorized by RCexp (Expiratory time constant): restrictive (RCExp <0.6); obstructive (RCExp >0.9); normal (RCExp 0.6 - 0.9).
- Software version SW3.0.0 or superior and the IntelliSync+ software tool available in invasive and non-invasive ventilation.
- Presence of asyncronies in pressure and volume curves tracings of the ventilator.
- Signed informed content.
Who cannot join
- Pregnant
- On extracorporeal respiratory support (ECMO or ECCO2R)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Prevalence of Asynchronies During Mechanical Ventilation With Manual Versus Automatic Adjustment Ventilator Settings Using the INTELLISYNC+® (HAMILTON) Tool. A Randomized Controlled Study
Asynchronies between the patient and the artificial ventilator are a frequent problem. They may cause altered sleep, ventilator-induced lung injury, prolong length of ICU stay, cause neuro-psycologic complications and increase mortality. Although reducing their incidence through ventilator setting adjustments is possible, they frequently go undetected and it also requires that attendings remain at the bedside to repeatedly modify ventilator parameters. Ventilator systems may detect and automatically adjust parameters of mechanical ventilation. This would avoid delays in detection and adjustment if the intensivist is not immediately available. The investigators intend to study an automatic detection and adjustment tool which is incorporated in the ventilator software.
Read the detailed description
The prevalence and time course of asynchronies will be evaluated in subjects under invasive (n=40) or non-invasive (n=40) mechanical ventilation. Intensivist-optimized ventilator settings will be compared to a software tool (Hamilton ventilators, Intellisync+) in its capacity to control and adjust the triggering and cycling by analysis of the ventilator curves.
The outcome variable is the percentage of the duration of asynchronies during the two 2-hour study periods.
This pilot study has a prospective, randomized cross-over design. The order of the 2 study periods will be randomized to either start with "control" with manual adjustment or "automated adjustment" with Intellisync+.
The total sample size is 80 subjects, 40 receiving invasive mechanical ventilation and 40 on non-invasive mechanical ventilation.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Intellisync+
- Keywords
- Asyncronies, Mechanical ventilation, Automatic detection and adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intellisync+Device
mechanical ventilator software automatically detecting and adjusting ventilator parameters to control or reduce the number of events.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Optimized ventilator settings to control and reduce the number of asynchronies |
| Activated automatic detection and adjustment of asynchronies | Active comparator | Active mode of a mechanical ventilator software automatically detecting and adjusting ventilator parameters to control or reduce the number of events. Receives: Device: Intellisync+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of asyncronies
duration of asyncronies expressed as percentage of time during the respective 2-hour study periods
Measured: two hours per study arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start15 Feb 2024
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Why it stopped: Futility. Intermediate analysis shows no difference in outcome variables
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Model description
- Two 2-hour periods: 1) "off mode" consisting of a control period with optimized ventilator parameters and 2) "on mode" with an active automated detection and adjustment for asynchronies. The starting first period is randomized.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Responsible party
- Principal investigator, Miguel Sanchez Garcia, Hospital San Carlos, Madrid
- Investigators
- Miguel Sanchez-Garcia, MD, Study chair, Hospial Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295237
- Sponsor's protocol ID
- i-Sync
- Acronym
- i-Sync
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Prevalence of Asynchronies During Mechanical Ventilation With Manual Versus Automatic Adjustment Ventilator Settings Using the INTELLISYNC+® (HAMILTON) Tool. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06295237
- Acronym / sponsor ID
- i-Sync / i-Sync
- Conditions
- Mechanical Ventilation Complication
- Keywords
- Asyncronies, Mechanical ventilation, Automatic detection and adjustment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility. Intermediate analysis shows no difference in outcome variables
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 6 Mar 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.
Asynchronies between the patient and the artificial ventilator are a frequent problem. They may cause altered sleep, ventilator-induced lung injury, prolong length of ICU stay, cause neuro-psycologic complications and increase mortality. Although reducing their incidence through ventilator setting adjustments is possible, they frequently go undetected and it also requires that attendings remain at the bedside to repeatedly modify ventilator parameters. Ventilator systems may detect and automatically adjust parameters of mechanical ventilation. This would avoid delays in detection and adjustment if the intensivist is not immediately available. The investigators intend to study an automatic detection and adjustment tool which is incorporated in the ventilator software.
Detailed description
The prevalence and time course of asynchronies will be evaluated in subjects under invasive (n=40) or non-invasive (n=40) mechanical ventilation. Intensivist-optimized ventilator settings will be compared to a software tool (Hamilton ventilators, Intellisync+) in its capacity to control and adjust the triggering and cycling by analysis of the ventilator curves.
The outcome variable is the percentage of the duration of asynchronies during the two 2-hour study periods.
This pilot study has a prospective, randomized cross-over design. The order of the 2 study periods will be randomized to either start with "control" with manual adjustment or "automated adjustment" with Intellisync+.
The total sample size is 80 subjects, 40 receiving invasive mechanical ventilation and 40 on non-invasive mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two 2-hour periods: 1) "off mode" consisting of a control period with optimized ventilator parameters and 2) "on mode" with an active automated detection and adjustment for asynchronies. The starting first period is randomized.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Optimized ventilator settings to control and reduce the number of asynchronies |
| Activated automatic detection and adjustment of asynchronies | Active comparator | Device: Intellisync+Active mode of a mechanical ventilator software automatically detecting and adjusting ventilator parameters to control or reduce the number of events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >17 years
- Partial ventilatory support ("SPONT" mode) connected to Hamilton C1 model, irrespective of chronic restrictive or obstructive lung disease, categorized by RCexp (Expiratory time constant): restrictive (RCExp <0.6); obstructive (RCExp >0.9); normal (RCExp 0.6 - 0.9).
- Software version SW3.0.0 or superior and the IntelliSync+ software tool available in invasive and non-invasive ventilation.
- Presence of asyncronies in pressure and volume curves tracings of the ventilator.
- Signed informed content.
Key exclusion criteria (2 listed)
- Pregnant
- On extracorporeal respiratory support (ECMO or ECCO2R)
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 |
|---|---|---|
| Intellisync+mechanical ventilator software automatically detecting and adjusting ventilator parameters to control or reduce the number of events. | Device | Activated automatic detection and adjustment of asynchronies |
Primary outcome
Duration of asyncronies
Time frame: two hours per study arm
duration of asyncronies expressed as percentage of time during the respective 2-hour study periods
Results and safety
The study was stopped early (reason given: Futility. Intermediate analysis shows no difference in outcome variables). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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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.
Miguel Sanchez-Garcia, MD study chair
Hospial Clinico San Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intellisync+ in people with Mechanical Ventilation Complication, run by Hospital San Carlos, Madrid at 1 site in Spain.
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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 7 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 Spain. 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 was stopped early (reason given: Futility. Intermediate analysis shows no difference in outcome variables). 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?
Duration of asyncronies (time frame: two hours per study arm). 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 7 Mar 2025; AzTrials last refreshed its copy on 29 Oct 2026.