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Clinical Trials/NCT05670093
NCT05670093
Recruiting
Not Applicable

Neural Pressure Support, a Randomized Crossover Trial

Karolinska Institutet1 site in 1 country22 target enrollmentMay 17, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Failure
Sponsor
Karolinska Institutet
Enrollment
22
Locations
1
Primary Endpoint
Patient-ventilator asynchronies
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 17, 2022
End Date
December 30, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Francesca Campoccia Jalde

Francesca Campoccia Jalde, MD, PhD

Karolinska Institutet

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.

Outcomes

Primary Outcomes

Patient-ventilator asynchronies

Time Frame: 20 minutes ventilatory traces recording

quantification of asynchronies by the use of the Edi catheter

Secondary Outcomes

  • respiratory muscle unloading(20 minutes ventilatory traces recording)

Study Sites (1)

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