Status:
TERMINATED
EASiVENT Study Comparing INTELLiVENT-ASV vs Non Automated Ventilation in Adult ICU Patients
Lead Sponsor:
Hamilton Medical AG
Conditions:
Acute Respiratory Failure
Coma
Eligibility:
All Genders
21+ years
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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 involving mechanical ventilation for the duration of study
- Signature of the informed consent by the patient or his/her next-of-kin according to country or state regulation.
Exclusion
- 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 to congenital 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 preclude informed consent (by the spouse/next of kin), make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving 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 acute respiratory 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
Key Trial Info
Start Date :
March 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2022
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04400643
Start Date
March 20 2020
End Date
July 18 2022
Last Update
October 23 2024
Active Locations (1)
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1
Centro Hospitalar Universitário de Lisboa Central
Lisbon, Portugal, 1150-199