ClinicalTrials.gg
Status unknownNCT05670093NPSUpdated Sep 19, 2024

Neural Pressure Support, Synchrony and Respiratory Muscle Unloading

An interventional study of Neural Pressure Support (mode of mechanical ventilation) in Acute Respiratory Failure, sponsored by Karolinska Institutet. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2024), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled May 2022, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Respiratory Failure
03

In context

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,146 studies on the registry; 275 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-Patients intubated for more than 24 hours in the weaning phase from the ventilator.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • 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)

Interventions

  • DeviceNeural 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

06

What researchers measure

Primary outcomes

  1. Patient-ventilator asynchronies

    quantification of asynchronies by the use of the Edi catheter

    Time frame: 20 minutes ventilatory traces recording

Secondary outcomes

  1. respiratory muscle unloading

    quantification of muscle unloading by use of Pes

    Time frame: 20 minutes ventilatory traces recording

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2022 (actual). Primary completion is estimated for Dec 2025, 43 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2022
First posted
Jan 4, 2023
StartActual
May 17, 2022
Primary completionEst.
Dec 31, 2025
CompletionEst.
Jun 1, 2026
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05670093
Responsible party
Francesca Campoccia Jalde (Francesca Campoccia Jalde, MD, PhD, Karolinska Institutet) — Principal investigator
First posted
Jan 4, 2023
Start date
May 17, 2022
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

Campoccia Jalde
Contact
francesca.campoccia-jalde@regionstockholm.se
+46703947741
Karolinska University Hospital
Contact
Francesca Campoccia Jalde
principal investigator · Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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