Neural Pressure Support, Synchrony and Respiratory Muscle Unloading

Acute Respiratory Failure Clinical Trial

— NPS  

Official title:

Neural Pressure Support, a Randomized Crossover Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05670093
• Other study ID #: k 2021-5369
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2023
• Source: Karolinska Institutet
• Contact: Campoccia Jalde
• Phone: +46703947741
• Email: francesca.campoccia-jalde[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Solna

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-ventilator asynchronies	quantification of asynchronies by the use of the Edi catheter	20 minutes ventilatory traces recording
Secondary	respiratory muscle unloading	quantification of muscle unloading by use of Pes	20 minutes ventilatory traces recording