Menu
Recruiting NCT05670093

Neural Pressure Support, Synchrony and Respiratory Muscle Unloading

No phase Interventional Acute Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neural Pressure Support (mode of mechanical ventilation).
Who it may be relevant to
Registry conditions: Acute Respiratory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Neural Pressure Support, a Randomized Crossover Trial

Overview

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

  • Device 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

Primary outcome measures

  • Patient-ventilator asynchronies [Time frame: 20 minutes ventilatory traces recording]
Secondary outcome measures (1)
  • respiratory muscle unloading [Time frame: 20 minutes ventilatory traces recording]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Karolinska University Hospital — Solna

Identifiers

NCT: NCT05670093 · k 2021-5369

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗