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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04827927
Other study ID # INTELLiPOWER
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 5, 2021
Est. completion date July 1, 2023

Study information

Verified date August 2023
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Several studies suggest fully-automated ventilation to ventilate with a lower amount of MP in unselected ICU patients, patients after cardiac surgery, and patients with and without ARDS. The current study will directly compare the amount of MP in invasively ventilated critically ill patients by calculating MP breath-by-breath, using the various equations proposed in the literature.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Procedure: INTELLiVENT-ASV
With INTELLiVENT-ASV, the patient's conditions, 'ARDS', 'Chronic Hypercapnia' or 'Traumatic Brain Injury' can be chosen, if applicable. The controllers for minute volume, PEEP and FiO2 are all activated, and the target shifts for etCO2 and SpO2 are adjusted, if necessary.
Procedure: Conventional ventilation
With conventional ventilation, the same etCO2 and SpO2 levels are targeted as with INTELLiVENT-ASV, but here the caregiver is fully responsible for choosing the settings.

Locations

Country Name City State
Netherlands Academic Medical Center Amsterdam Noord-Holland
Netherlands Reinier de Graaf Gasthuis Delft
Netherlands Dijklander Ziekenhuis Hoorn

Sponsors (4)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Dijklander Ziekenhuis, Reinier de Graaf Groep, University of Zurich

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary The amount of MP delivered with each form of invasive ventilation The amount of MP delivered with INTELLiVENT-ASV and conventional ventilation 3 hours per ventilation mode
Secondary Duration of ventilation Duration of ventilation in survivors first 28 days after start of ventilation
Secondary ICU-length and hospital of stay Length of stay in the intensive care unit and in the hospital first 28 days after start of ventilation
Secondary 28 day-mortality Any death during ICU-, hospital-stay and within 28 days first 28 days after start of ventilation
Secondary Tidal volume Tidal volume in ml/kg 3 hours per ventilation mode
Secondary Respiratory rate Respiratory rate per minute 3 hours per ventilation mode
Secondary Pmax Maximum airway pressure in cmH2O 3 hours per ventilation mode
Secondary Driving pressure Difference between end-inspiratory pressure and total Positieve End Expiratory Pressure in cmH2O 3 hours per ventilation mode
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