EASiVENT Study Comparing INTELLiVENT-ASV vs Non Automated Ventilation in Adult ICU Patients

Last updated: October 21, 2024
Sponsor: Hamilton Medical AG
Overall Status: Terminated

Phase

N/A

Condition

Chronic Obstructive Pulmonary Disease (Copd)

Lung Injury

Chronic Bronchitis

Treatment

INTELLiVENT-ASV

Non-automated ventilation

Clinical Study ID

NCT04400643
EASiVENT
  • Ages > 21
  • All Genders

Study Summary

The purpose of the study is to assess the safety and efficacy of INTELLiVENT-ASV (Adaptive Support Ventilation) in adult ICU patients comparing to non automated ventilation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Weight greater than 40 kg

  • Under invasive ventilation

  • Expected to be mechanically ventilated after enrollment for at least 24 hours

  • Agrees to not participate in other interventional research studies involvingmechanical ventilation for the duration of study

  • Signature of the informed consent by the patient or his/her next-of-kin according tocountry or state regulation.

Exclusion

Exclusion Criteria:

  • Fulfilling weaning criteria according to the weaning procedure of the ICU

  • Need for "rescue therapy" (e.g: ECMO)

  • Brain death status

  • Respiratory drive disorder (Cheyne-Stokes breathing)

  • Arterial hypoxia due to a non-pulmonary condition (right-to-left shunting due tocongenital disease, hepato-pulmonary syndrome, )

  • Broncho-pleural fistula

  • Chronic or acute dyshemoglobinemia: eg.: acute CO poisoning

  • Chronic respiratory failure requiring long term invasive ventilation;

  • Moribund patient

  • Patient under guardianship, deprived of liberties

  • Any other condition, that in the opinion of the IoR/designee, would precludeinformed consent (by the spouse/next of kin), make study participation unsafe,complicate interpretation of study outcome data, or otherwise interfere withachieving the study objectives.

  • Low quality index on the SpO2 (Oxygen Saturation Measured by Pulse Oximetry)measurement

  • Patients already enrolled in the present study in a previous episode of acuterespiratory failure

  • High PaCO2 - ETCO2 gap (> 2.6 kPa or 19.5 mmHg) for > 3 hours

  • Patient tracheostomized at the time of inclusion

  • Patient ventilated with helium

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: INTELLiVENT-ASV
Phase:
Study Start date:
March 20, 2020
Estimated Completion Date:
July 18, 2022

Study Description

EASiVENT is a prospective, multicenter, randomized (1:1), Controlled Study. This study is single-blind because only the subject will be unaware of the ventilation modality administered. The reference treatment used for comparison is a combination of controlled modes for passive subjects (volume control or pressure control) and assisted/spontaneous modes for active subjects (synchronized intermittent mechanical ventilation or pressure support)

Connect with a study center

  • Centro Hospitalar Universitário de Lisboa Central

    Lisbon, 1150-199
    Portugal

    Site Not Available

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