Neural Pressure Support, Synchrony and Respiratory Muscle Unloading (NPS)

Neural Pressure Support, a Randomized Crossover Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Device: Neural Pressure Support (mode of mechanical ventilation)

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 Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Campoccia Jalde; Phone Number: +46703947741; Email: francesca.campoccia-jalde@regionstockholm.se
• Study Contact Backup: Name: Karolinska University Hospital

Study Locations

• Sweden
  • Solna, Sweden, 17176
    • Recruiting
    • Karolinska University Hospital
    • Contact: Francesca Campoccia Jalde, MD, PhD; Phone Number: +46703947741; Email: francesca.campoccia-jalde@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neural Pressure Support; Patients will be ventilated in Pressure Support and Neural Pressure Support at 3 different levels of support in randomized order	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Francesca Campoccia Jalde, Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 19, 2022
• First Submitted That Met QC Criteria: January 2, 2023
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: k 2021-5369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No