INTELLiVENT-ASV Using Mainstream Versus Sidestream End-Tidal CO2 Monitoring (INTELLiSTREAM)

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

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

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation Complication; Postoperative Care; Intensive Care Unit
• Intervention / Treatment: Device: Sidestream capnography using the 'Respironics LoFlo Sidestream CO2 Module'; Device: Mainstream capnography using the 'Respironics Capnostat 5 Mainstream CO2 sensor'

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam UMC location AMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INTELLiVENT-ASV with sidestream capnography; Patients randomized into the 'Sidestream capnography'-arm will receive postoperative ventilation on the ICU with INTELLiVENT-ASV with sidestream etCO2 monitoring.	Device: Sidestream capnography using the 'Respironics LoFlo Sidestream CO2 Module'; Study patients randomized into the 'Sidestream capnography' arm will receive postoperative ventilation on the ICU with INTELLiVENT-ASV with sidestream etCO2 monitoring using the 'Respironics LoFlo Sidestream CO2 Module'.
Active Comparator: INTELLiVENT-ASV with mainstream capnography; Patients randomized into the 'Mainstream capnography'-arm will receive postoperative ventilation on the ICU with INTELLiVENT-ASV with mainstream etCO2 monitoring.	Device: Mainstream capnography using the 'Respironics Capnostat 5 Mainstream CO2 sensor'; Study patients randomized into the 'Mainstream capnography' arm will receive postoperative ventilation on the ICU with INTELLiVENT-ASV with mainstream etCO2 monitoring using the 'Respironics Capnostat 5 Mainstream CO2 sensor'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage (%) of time spent in the 'optimal' zone of ventilation during the first 3 hours of postoperative ventilation using INTELLiVENT-ASV.	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)	During the first 3 hours, since admission on the intensive care unit (ICU) with the start of INTELLiVENT-ASV ventilation mode.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage (%) of time spent in the 'optimal', 'acceptable' and 'critical' zones during the first 3 hours of postoperative ventilation using INTELLiVENT-ASV.	An optimal zone as defined under Primary Outcome Measure An acceptable zone = VT = 8-12 ml/kg PBW with an etCO2 = 25-30 or 45-50 mmHg, a Pmax = 31-36 cmH2O and a SpO2 = 85-93% or >98%. A critical zone = VT >12 ml/kg PBW or an etCO2 = <25 or ≥51 mmHg, a Pmax ≥36 cmH2O or SpO2 <85%.	During the first 3 hours, since admission on the ICU with the start of the INTELLiVENT-ASV ventilation mode.
Time to spontaneous breathing	Time to spontaneous breathing is defined as the time from start of ventilation at the ICU until five or more consecutive spontaneous breaths.	Time from start of ventilation at the ICU until five or more consecutive spontaneous breaths, assessed up to 30 days.
Duration of weaning	Duration of weaning is defined as time from cessation of sedatives and of a rectal temperature > 35.5ºC to tracheal extubation.	Time from cessation of sedatives and of a rectal temperature > 35.5ºC to tracheal extubation, assessed up to 30 days.
Duration of postoperative ventilation	Duration of postoperative ventilation, defined as time from start of ventilation at the ICU until tracheal extubation	Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Proportion of failed extubations	Failed extubations are defined as re-intubation within 48 hours after extubation and considering only patients who survived and did not undergo re-sternotomy during this time.	Within 48 hours after extubation.
Development of postoperative pulmonary complications	Postoperative pulmonary complications is collapsed composite of pneumonia, defined as a patient receiving antibiotics and meets at least one of the following criteria: new or changed sputum, new or changed lung opacities on chest radiography when clinically indicated, tympanic temperature > 38.3C, white blood cell count 12,000/mm^3, pneumothorax, defined as air in he pleural space with no vascular bed surrounding the visceral pleura on chest radiography or severe atelectasis, defined as lung opacification with a shift of the mediastinum, hilum or hemidiaphragm towards the affected area, and compensatory over-inflation in the adjacent non-atelectatic lung on chest radiography.	During first 5 postoperative days days.
Length of stay in ICU		From admission to ICU to ICU discharge of the patient, assessed up to 30 days.
Readmission to ICU		From admission to ICU to hospital 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	Loss of etCO2 monitoring requiring a correction by ICU nurses.	During the first 3 hours, since admission on the ICU with the start of INTELLiVENT-ASV ventilation mode.
Incidence of hypoxemia	Hypoxemia is defined as percentage of breath with pulse oximetry saturation <85% but only when SpO2 had a quality index >50%.	Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Ventilatory parameters: pressures	Positive end expiratory pressure (PEEP), maximum airway pressure (Pmax) and plateau pressure (Pplat)	Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Ventilation parameters: volumes	Tidal volume (VT) and minute volume (MV)	Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Ventilation parameters: respiratory rate	Respiratory rate (RR)	Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Ventilation parameters: oxygenation	Fraction inspired oxygen (FiO2) and pulse oximetry (SpO2)	Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Ventilation parameters: capnography	End-tidal CO2 (etCO2)	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.

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Marcus J. Schultz, Prof. dr., Amsterdam University Medical Centers location 'AMC'

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Actual): April 21, 2022
• Study Completion (Actual): May 21, 2022

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Intensive Care Unit; 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; Automated Mechanical ventilation
• Other Study ID Numbers: INTELLiSTREAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD sharing plan will follow

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No