Neural Pressure Support, Synchrony and Respiratory Muscle Unloading

Not Applicable

Recruiting

• Conditions: Acute Respiratory Failure
• Interventions: Device: Neural Pressure Support (mode of mechanical ventilation)

• Registration Number: NCT05670093
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study Start: 2022-05-17
• Study First Submitted: 2022-11-19
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-02
• Last Update Submitted: 2023-01-02
• Study First Posted: 2023-01-04
• Last Update Posted: 2023-01-04
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neural Pressure Support	Neural Pressure Support (mode of mechanical ventilation)	Patients will be ventilated in Pressure Support and Neural Pressure Support at 3 different levels of support in randomized order

Primary Outcome Measures

Name	Time	Method
Patient-ventilator asynchronies	20 minutes ventilatory traces recording	quantification of asynchronies by the use of the Edi catheter

Secondary Outcome Measures

Name	Time	Method
respiratory muscle unloading	20 minutes ventilatory traces recording	quantification of muscle unloading by use of Pes

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Solna, Sweden