Neural Pressure Support, Synchrony and Respiratory Muscle Unloading

NCT ID: NCT05670093

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-17

Study Completion Date

2026-06-01

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Interventional prospective study. Each participant is ventilated both on PS and NPS at 3 different support levels.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neural Pressure Support

Patients will be ventilated in Pressure Support and Neural Pressure Support at 3 different levels of support in randomized order

Group Type EXPERIMENTAL

Neural Pressure Support (mode of mechanical ventilation)

Intervention Type 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

Interventions

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Neural Pressure Support (mode of mechanical ventilation)

Nasogastric tube will be removed and replaced by a Esophageal catheter and Electrical Diaphragm activity catheter and mechanical ventilation in mode Neural Pressure Support

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Francesca Campoccia Jalde

Francesca Campoccia Jalde, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesca Campoccia Jalde

Role: PRINCIPAL_INVESTIGATOR

Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.

Locations

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Karolinska University Hospital

Solna, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Campoccia Jalde

Role: CONTACT

+46703947741

Karolinska University Hospital

Role: CONTACT

Facility Contacts

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Francesca Campoccia Jalde, MD, PhD

Role: primary

+46703947741

Other Identifiers

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k 2021-5369

Identifier Type: -

Identifier Source: org_study_id

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