NPS: Neural Pressure Support, Synchrony and Respiratory Muscle Unloading

Sponsor

Karolinska Institutet (Other)

Overall Status

Recruiting

CT.gov ID

NCT05670093

Collaborator

(none)

Enrollment

Location

Arm

31.5

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Failure	Device: Neural Pressure Support (mode of mechanical ventilation)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Interventional prospective study. Each participant is ventilated both on PS and NPS at 3 different support levels.Interventional prospective study. Each participant is ventilated both on PS and NPS at 3 different support levels.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Neural Pressure Support, a Randomized Crossover Trial

Actual Study Start Date :

May 17, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Patient-ventilator asynchronies [20 minutes ventilatory traces recording]
quantification of asynchronies by the use of the Edi catheter

Secondary Outcome Measures

respiratory muscle unloading [20 minutes ventilatory traces recording]
quantification of muscle unloading by use of Pes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hospital	Solna		Sweden	17176

Sponsors and Collaborators

Karolinska Institutet

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Francesca Campoccia Jalde, Francesca Campoccia Jalde, MD, PhD, Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT05670093

Other Study ID Numbers:

k 2021-5369

First Posted:

Jan 4, 2023

Last Update Posted:

Jan 4, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Respiratory Insufficiency

Study Results

No Results Posted as of Jan 4, 2023