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
About this trial
This is an interventional treatment trial for Acute Respiratory Failure
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.
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
NCT ID
NCT05670093
First Posted
November 19, 2022
Last Updated
January 2, 2023
Sponsor
Karolinska Institutet
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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