Neural Pressure Support, Synchrony and Respiratory Muscle Unloading

NCT05670093 | Recruiting

• 1 other identifier: k 2021-5369
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Patient-ventilator asynchronies

  quantification of asynchronies by the use of the Edi catheter

  20 minutes ventilatory traces recording

Secondary Outcomes (1)

• respiratory muscle unloading

  20 minutes ventilatory traces recording

Study Arms (1)

Neural Pressure Support

EXPERIMENTAL

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

Neural Pressure Support (mode of mechanical ventilation) DEVICE

Nasogastric tube will be removed and replaced by a Esophageal catheter and Electrical Diaphragm activity catheter and mechanical ventilation in mode Neural Pressure Support

Neural Pressure Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital

Solna, 17176, Sweden

RECRUITING

Study Officials

• Francesca Campoccia Jalde

  Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Campoccia Jalde

CONTACT

+46703947741; francesca.campoccia-jalde@regionstockholm.se

Karolinska University Hospital

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Francesca Campoccia Jalde, MD, PhD

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

Study Record Dates

• First Submitted: November 19, 2022
• First Posted: January 4, 2023
• Study Start: May 17, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)