INTELLiVENT-ASV Using Mainstream Versus Sidestream End-Tidal CO2 Monitoring- a Randomized Noninferiority Clinical Trial in Cardiac Surgery Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Mechanical Ventilation Complication
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- The percentage (%) of time spent in the 'optimal' zone of ventilation during the first 3 hours of postoperative ventilation using INTELLiVENT-ASV.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
Prof. Dr. Marcus J. Schultz
Principal investigator and clinical professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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
Outcomes
Primary Outcomes
The percentage (%) of time spent in the 'optimal' zone of ventilation during the first 3 hours of postoperative ventilation using INTELLiVENT-ASV.
Time Frame: During the first 3 hours, since admission on the intensive care unit (ICU) with the start of INTELLiVENT-ASV ventilation mode.
A breath is considered to be in the 'optimal zone' when the following criteria are met: tidal volume (VT) ≤8 ml/kg predicted body weight (PBW) and maximum airway pressure (Pmax) ≤ 30 cmH2O and end tidal CO2 (etCO2) = 30-46 mmHg and pulse oximetry saturation (SpO2) = 93-98%. The ventilation zones are as defined in earlier studies (ClinicalTrials.gov Identifier: NCT03180203)
Secondary Outcomes
- Ventilation parameters: capnography(Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.)
- The percentage (%) of time spent in the 'optimal', 'acceptable' and 'critical' zones during the first 3 hours of postoperative ventilation using INTELLiVENT-ASV.(During the first 3 hours, since admission on the ICU with the start of the INTELLiVENT-ASV ventilation mode.)
- Time to spontaneous breathing(Time from start of ventilation at the ICU until five or more consecutive spontaneous breaths, assessed up to 30 days.)
- Readmission to ICU(From admission to ICU to hospital discharge of the patient, assessed up to 30 days.)
- Duration of weaning(Time from cessation of sedatives and of a rectal temperature > 35.5ºC to tracheal extubation, assessed up to 30 days.)
- Length of stay in ICU(From admission to ICU to ICU discharge of the patient, assessed up to 30 days.)
- Mortality in the ICU(From admission to ICU to ICU discharge of the patient, assessed up to 30 days.)
- Loss of capnography signal(During the first 3 hours, since admission on the ICU with the start of INTELLiVENT-ASV ventilation mode.)
- Duration of postoperative ventilation(Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.)
- Ventilatory parameters: pressures(Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.)
- Proportion of failed extubations(Within 48 hours after extubation.)
- Incidence of hypoxemia(Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.)
- Ventilation parameters: respiratory rate(Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.)
- Ventilation parameters: oxygenation(Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.)
- Development of postoperative pulmonary complications(During first 5 postoperative days days.)
- Ventilation parameters: volumes(Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.)
- Clinically indicated arterial blood gas analyses(Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.)