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

Primary Purpose

Acute Respiratory Failure

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Neural Pressure Support (mode of mechanical ventilation)
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Karolinska University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neural Pressure Support

Arm Description

Patients will be ventilated in Pressure Support and Neural Pressure Support at 3 different levels of support in randomized order

Outcomes

Primary Outcome Measures

Patient-ventilator asynchronies
quantification of asynchronies by the use of the Edi catheter

Secondary Outcome Measures

respiratory muscle unloading
quantification of muscle unloading by use of Pes

Full Information

First Posted
November 19, 2022
Last Updated
January 2, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT05670093
Brief Title
Neural Pressure Support, Synchrony and Respiratory Muscle Unloading
Acronym
NPS
Official Title
Neural Pressure Support, a Randomized Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interventional prospective study. Each participant is ventilated both on PS and NPS at 3 different support levels.
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neural Pressure Support
Arm Type
Experimental
Arm Description
Patients will be ventilated in Pressure Support and Neural Pressure Support at 3 different levels of support in randomized order
Intervention Type
Device
Intervention Name(s)
Neural Pressure Support (mode of mechanical ventilation)
Intervention Description
Nasogastric tube will be removed and replaced by a Esophageal catheter and Electrical Diaphragm activity catheter and mechanical ventilation in mode Neural Pressure Support
Primary Outcome Measure Information:
Title
Patient-ventilator asynchronies
Description
quantification of asynchronies by the use of the Edi catheter
Time Frame
20 minutes ventilatory traces recording
Secondary Outcome Measure Information:
Title
respiratory muscle unloading
Description
quantification of muscle unloading by use of Pes
Time Frame
20 minutes ventilatory traces recording

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Campoccia Jalde
Phone
+46703947741
Email
francesca.campoccia-jalde@regionstockholm.se
First Name & Middle Initial & Last Name or Official Title & Degree
Karolinska University Hospital
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesca Campoccia Jalde
Organizational Affiliation
Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Solna
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Campoccia Jalde, MD, PhD
Phone
+46703947741
Email
francesca.campoccia-jalde@regionstockholm.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Neural Pressure Support, Synchrony and Respiratory Muscle Unloading

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