NCT04827927

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 5, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

1.7 years

First QC Date

March 29, 2021

Last Update Submit

August 23, 2023

Conditions

Mechanical VentilationMechanical Power

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Duration of ventilation

    first 28 days after start of ventilation

  • ICU-length and hospital of stay

    first 28 days after start of ventilation

  • 28 day-mortality

    first 28 days after start of ventilation

  • Tidal volume

    3 hours per ventilation mode

  • Respiratory rate

    3 hours per ventilation mode

  • +2 more secondary outcomes

Study Arms (2)

INTELLiVENT-ASV

EXPERIMENTAL

Use of INTELLiVENT-ASV during 3 hours with 30 minutes wash-out time before.

Procedure: Procedure: INTELLiVENT-ASV

Conventional Ventilation

ACTIVE COMPARATOR

Use of conventional ventilation during 3 hours with 30 minutes wash-out time before.

Procedure: Procedure: Conventional ventilation

Interventions

Procedure: INTELLiVENT-ASVPROCEDURE

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.

INTELLiVENT-ASV
Procedure: Conventional ventilationPROCEDURE

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.

Conventional Ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted to one of the participating ICUs;
  • Receiving invasive ventilation through a standard endotracheal (i.e., oral) tube;
  • Expected to be ventilated \> 24 hours; and
  • Ventilation is applied by a ventilator that can provide INTELLiVENT-ASV and conventional ventilation.

You may not qualify if:

  • Age under 18 years;
  • No written informed consent;
  • Morbidly obese; and
  • Any contra-indication for use of INTELLiVENT-ASV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, Netherlands

Location

Dijklander Ziekenhuis

Hoorn, Netherlands

Location

Related Publications (1)

  • Buiteman-Kruizinga LA, Serpa Neto A, Botta M, List SS, de Boer BH, van Velzen P, Buhler PK, Wendel Garcia PD, Schultz MJ, van der Heiden PLJ, Paulus F; INTELLiPOWER-investigators. Effect of automated versus conventional ventilation on mechanical power of ventilation-A randomized crossover clinical trial. PLoS One. 2024 Jul 30;19(7):e0307155. doi: 10.1371/journal.pone.0307155. eCollection 2024.

    PMID: 39078857DERIVED

Study Officials

  • Marcus J Schultz, MD, PhD

    Department of Intensive Care, Amsterdam University Medical Centre - location AMC

    PRINCIPAL INVESTIGATOR

  • Frederique Paulus, PhD

    Department of Intensive Care, Amsterdam University Medical Centre - location AMC

    STUDY DIRECTOR

  • Laura A Buiteman-Kruizinga, RN, BSc

    Department of Intensive Care, Amsterdam University Medical Centre - location AMC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Marcus J. Schultz

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

July 5, 2021

Primary Completion

April 1, 2023

Study Completion

July 1, 2023

Last Updated

August 24, 2023

Record last verified: 2023-08

Locations

NL(3)