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INTELLiVENT*ASV Using Mainstream versus Sidestream End*Tidal CO2 Monitoring* a Randomized Noninferiority Clinical Trial in Cardiac Surgery Patients

INTELLiVENT*ASV Using Mainstream versus Sidestream End*Tidal CO2 Monitoring* a Randomized Noninferiority Clinical Trial in Cardiac Surgery Patients - INTELLiSTREAM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55109
Enrollment
72
Registered
2020-03-06
Start date
2020-06-30
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

automated mechanical ventilation post cardiac surgery

Interventions

Shortly after at arrival at the ICU, patients will be randomized to receive either ventilation with INTELLiVENT*ASV with mainstream capnography or with sidestream capnography.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Undergoing elective cardiac surgery in the Amsterdam UMC location 'AMC' * Planned admission to the ICU for postoperative ventilation * Expected to need postoperative ventilation for at least 2 hours

Exclusion criteria

Exclusion criteria: * Age

Design outcomes

Primary

MeasureTime frame
The primary study endpoint is the percentage of breaths a patient spends inside the *optimal* zone of ventilation, as defined before (i.e., tidal volume—

Secondary

MeasureTime frame
The percentage of time spent in other ventilation zones, as defined in the protocol. Time to spontaneous breathing, duration of weaning, loss of etCO2 signal, duration of postoprative ventilation and ventilator parameters as well as results of clinically- indicated arterial blood gas analysis.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)