Clinical trial NCT04599491: INTELLiVENT-ASV Using Mainstream Versus Sidestream End-Tidal CO2 Monitoring
Official title: INTELLiVENT-ASV Using Mainstream Versus Sidestream End-Tidal CO2 Monitoring- a Randomized Noninferiority Clinical Trial in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Intensive Care Unit
Postoperative Care
Keywords: Mechanical Ventilation
INTELLiVENT-ASV
Quality of Breath
Elective Cardiac Surgery
Postoperative Pulmonary Complications
Lung Protective ventilation
Mainstream Capnography
Sidestream Capnography
Noninferiority trial
Closed Loop Ventilation
Intensive Care Unit
Automated Mechanical ventilation
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: INTELLiSTREAM is a single-center randomized clinical noninferiority trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background

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.

Objective of the study

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.

Hypothesis

The investigators hypothesize that INTELLiVENT-ASV with sidestream capnography is noninferior to INTELLiVENT-ASV with mainstream capnography with respect to the percentage of breaths a patient spends within the 'optimal' zone of ventilation.

Study design

INTELLiSTREAM is a randomized noninferiority study.

Study population

The study population consists of consecutive elective cardiac surgery patients who are expected to need at least 2 hours of postoperative ventilation in the ICU of Amsterdam Medical University Centers, location 'AMC'.

Intervention

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

Primary outcome of the study

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 \< 30cm H2O, etCO2 between 30-46 mmHg and pulse oximetry between 93-98%).

Secondary outcomes

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 postoperative ventilation and ventilator parameters as well as results of clinically indicated arterial blood gas analysis.

Nature and extent of burden and risks associated with participation, benefit and group relatedness 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


Eligibility criteria: Inclusion Criteria:

* Undergoing elective cardiac surgery in the Amsterdam University Medical Centers, location 'AMC'
* Planned admission to the ICU for postoperative ventilation
* Expected to need postoperative ventilation for at least 2 hours

Exclusion Criteria:

* Age under 18 years
* Patients previously included in the current clinical trial
* Patients participation in other interventional clinical trials that could influence ventilator settings and ventilation parameters
* Patients with suspected or confirmed pregnancy
* Moribund patients

Primary outcomes:
measure: The percentage (%) of time spent in the 'optimal' zone of ventilation during the first 3 hours of postoperative ventilation using INTELLiVENT-ASV.
timeFrame: During the first 3 hours, since admission on the intensive care unit (ICU) with the start of INTELLiVENT-ASV ventilation mode.
Secondary outcomes:
measure: The percentage (%) of time spent in the 'optimal', 'acceptable' and 'critical' zones during the first 3 hours of postoperative ventilation using INTELLiVENT-ASV.
timeFrame: During the first 3 hours, since admission on the ICU with the start of the INTELLiVENT-ASV ventilation mode.
measure: Time to spontaneous breathing
timeFrame: Time from start of ventilation at the ICU until five or more consecutive spontaneous breaths, assessed up to 30 days.
measure: Duration of weaning
timeFrame: Time from cessation of sedatives and of a rectal temperature > 35.5ºC to tracheal extubation, assessed up to 30 days.
measure: Duration of postoperative ventilation
timeFrame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
measure: Proportion of failed extubations
timeFrame: Within 48 hours after extubation.
measure: Development of postoperative pulmonary complications
timeFrame: During first 5 postoperative days days.
measure: Length of stay in ICU
timeFrame: From admission to ICU to ICU discharge of the patient, assessed up to 30 days.
measure: Readmission to ICU
timeFrame: From admission to ICU to hospital discharge of the patient, assessed up to 30 days.
measure: Mortality in the ICU
timeFrame: From admission to ICU to ICU discharge of the patient, assessed up to 30 days.
measure: Loss of capnography signal
timeFrame: During the first 3 hours, since admission on the ICU with the start of INTELLiVENT-ASV ventilation mode.
measure: Incidence of hypoxemia
timeFrame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
measure: Ventilatory parameters: pressures
timeFrame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
measure: Ventilation parameters: volumes
timeFrame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
measure: Ventilation parameters: respiratory rate
timeFrame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
measure: Ventilation parameters: oxygenation
timeFrame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
measure: Ventilation parameters: capnography
timeFrame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
measure: Clinically indicated arterial blood gas analyses
timeFrame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC location AMC
Study officials:
affiliation: Amsterdam University Medical Centers location 'AMC'
name: Marcus J. Schultz, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: