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

September 11, 2024 updated by: Francesca Campoccia Jalde, Karolinska Institutet

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Karolinska University Hospital

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 20 minutes ventilatory traces recording
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
Time Frame: 20 minutes ventilatory traces recording
quantification of muscle unloading by use of Pes
20 minutes ventilatory traces recording

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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