The objective of this randomized noninferiority trial is to determine whether INTELLiVENT*ASV with sidestream capnography is noninferior to INTELLiVENT*ASV with mainstream capnography with regard to the percentage of breaths in a broadly accepted…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 < 10
ml/kg PBW, maximum airway pressure < 30 cm H2O, etCO2 between 30*46 mm Hg and
pulse oximetry between 93*98%).
Secondary outcome
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.
Background summary
INTELLiVENT*ASV, an automated closed*loop mode of mechanical ventilation,
available on Hamilton ventilators for clinical use, uses mainstream end*tidal
CO2 (etCO2) monitoring to adjust minute ventilation. However, sensors for
mainstream etCO2 monitoring are expensive and fragile. The less expensive and
more robust sensors for sidestream etCO2 monitoring could serve as a good
alternative to sensors for mainstream etCO2 monitoring.
Study objective
The objective of this randomized noninferiority trial is to determine whether
INTELLiVENT*ASV with sidestream capnography is noninferior to INTELLiVENT*ASV
with mainstream capnography with regard to the percentage of breaths in a
broadly accepted predefined *optimal* zone of ventilation.
Study design
A single*center randomized noninferiority study
Intervention
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.
Study burden and risks
Hamilton ventilators can use mainstream and sidestream etCO2 sensors.
INTELLiVENT*ASV is a safe mode of ventilation, also in patients who receive
postoperative ventilation. Furthermore, as all patients are sedated as part of
standard care during postoperative ventilation, the burden for the patient is
minimal.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
* Age < 18 years
* Patients previously included in the current clinical trial
* Patients participating in other interventional trials that could influence
ventilator settings and ventilation parameters
* Patients with suspected or confirmed pregnancy
* Moribund patients
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69797.018.19 |