Neural Pressure Support, Synchrony and Respiratory Muscle... | NCT05670093

Studies
Neural Pressure Support, Synchrony and Respiratory Muscle Unloading

NCT05670093

Sponsor

Karolinska Institutet

Status

Recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

22Estimated

Phase

Not Applicable

Conditions

Acute Respiratory Failure

Interventions

Neural Pressure Support (mode of mechanical ventilation)

Countries

Sweden

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

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 17, 2022Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Jun 1, 2026Estimated

First Submitted Date

Nov 19, 2022

First Submission Date that Met QC Criteria

Jan 2, 2023

First Posted Date

Jan 4, 2023Actual

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

Sep 11, 2024

Last Update Posted Date

Sep 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Francesca Campoccia Jalde, Francesca Campoccia Jalde, MD, PhD, Karolinska InstitutetPrincipal Investigator

Lead Sponsor

Karolinska InstitutetOTHER

Collaborators

Not provided

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

In this study patients who are intubated and on ventilator for more than 24h will be ventilated at three different level of support in Pressure Support and Neural Pressure Support to study patient-ventilator synchrony and muscle unloading.

Detailed Description

This study is an interventional randomized crossover study in intubated and mechanically ventilated patients for more than 24h. Eligible patients from whom informed consent is obtained and Pes and Edi catheter are successfully positioned are enrolled in the study. Patients will be ventilated in Pressure Support and Neural Pressure Support at three different level of assist (baseline, 50% and 150% of baseline respectively) in randomized order. Ventilator curves will be recorded and bloodgas obtained at the end of each study step, each lasting 20min.

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

22Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neural Pressure Support	Experimental	Patients will be ventilated in Pressure Support and Neural Pressure Support at 3 different levels of support in randomized order	Device: Neural Pressure Support (mode of mechanical ventilation)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neural Pressure Support (mode of mechanical ventilation)	Device	Nasogastric tube will be removed and replaced by a Esophageal catheter and Electrical Diaphragm activity catheter and mechanical ventilation in mode Neural Pressure Support

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient-ventilator asynchronies	quantification of asynchronies by the use of the Edi catheter	20 minutes ventilatory traces recording

Secondary Outcomes

Measure	Description	Time Frame
respiratory muscle unloading	quantification of muscle unloading by use of Pes	20 minutes ventilatory traces recording

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-Patients intubated for more than 24 hours in the weaning phase from the ventilator.

Exclusion Criteria:

bleeding disorders (PK INR>1,5 or APTT>50s or platelet count <50000/µL)
unstable circulation (requiring high vasopressor dose, for example Noradrenalin >0,2µg/kg/min)
severe lung disease (PFI ≤ 13,3 kPa)
fever> 38,5°C
pregnancy.

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

Name	Role	Phone	Extension	Email
Campoccia Jalde	Contact	+46703947741		francesca.campoccia-jalde@regionstockholm.se
Karolinska University Hospital	Contact

Overall Officials

Name	Affiliation	Role
Francesca Campoccia Jalde	Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital	Recruiting	Solna		17176	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided