Neural Pressure Support, Synchrony and Respiratory Muscle Unloading

Neural Pressure Support, a Randomized Crossover Trial

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05670093

Acronym

NPS

Enrollment

Registered

2023-01-04

Start date

2022-05-17

Completion date

2026-06-01

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

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.

Interventions

DEVICENeural 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Sweden

Contacts

Primary ContactCampoccia Jalde

francesca.campoccia-jalde@regionstockholm.se+46703947741

Backup ContactKarolinska University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026