Karolinska University Hospital
Solna, 17176, Sweden
Location status: Recruiting
Recruiting
NCT Number: NCT05670093
Neural Pressure Support, Synchrony and Respiratory Muscle Unloading
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Neural Pressure Support (mode of mechanical ventilation)
DeviceNasogastric tube will be removed and replaced by a Esophageal catheter and Electrical Diaphragm activity catheter and mechanical ventilation in mode Neural Pressure Support
Primary outcomes
-
Patient-ventilator asynchronies
Time frame: 20 minutes ventilatory traces recording
quantification of asynchronies by the use of the Edi catheter
Secondary outcomes
-
respiratory muscle unloading
Time frame: 20 minutes ventilatory traces recording
quantification of muscle unloading by use of Pes
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Karolinska Institutet
Other
Registry information
Official study title
Neural Pressure Support, a Randomized Crossover Trial
Acronym: NPS
Important dates
- Study start
- 2022
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Jan 4, 2023
- Registry last updated
- Sep 19, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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