Automatic Adjustment for Asynchronies During Mechanical V... | NCT06295237

Studies
Automatic Adjustment for Asynchronies During Mechanical Ventilation

NCT06295237

Sponsor

Hospital San Carlos, Madrid

Status

Terminated

Last Update Posted

Mar 7, 2025Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Mechanical Ventilation Complication

Interventions

Intellisync+

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Futility. Intermediate analysis shows no difference in outcome variables

Expanded Access Info

Start Date

Feb 15, 2024Actual

Primary Completion Date

Dec 15, 2024Actual

Completion Date

Dec 15, 2024Actual

First Submitted Date

Feb 28, 2024

First Submission Date that Met QC Criteria

Feb 28, 2024

First Posted Date

Mar 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2025

Last Update Posted Date

Mar 7, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Miguel Sanchez Garcia, Director Critical Care Department, Hospital San Carlos, MadridPrincipal Investigator

Lead Sponsor

Hospital San Carlos, MadridOTHER

Collaborators

Name	Class
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Device: Intellisync+

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intellisync+	Device	mechanical ventilator software automatically detecting and adjusting ventilator parameters to control or reduce the number of events.	Activated automatic detection and adjustment of asynchronies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of asyncronies	duration of asyncronies expressed as percentage of time during the respective 2-hour study periods	two hours per study arm

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Pregnant
On extracorporeal respiratory support (ECMO or ECCO2R)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Miguel Sanchez-Garcia, MD	Hospial Clinico San Carlos	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinico San Carlos		Madrid	Madrid	28040	Spain

Intervention 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.