INTELLiVENT-ASV Using Mainstream Versus Sidestream End-Tidal CO2 Monitoring

NCT04599491 | Completed

• 1 other identifier: INTELLiSTREAM
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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.

• Duration of weaning

  Time from cessation of sedatives and of a rectal temperature > 35.5ºC to tracheal extubation, assessed up to 30 days.

• Duration of postoperative ventilation

  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.

Study Arms (2)

INTELLiVENT-ASV with sidestream capnography

EXPERIMENTAL

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'

INTELLiVENT-ASV with mainstream capnography

ACTIVE COMPARATOR

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'

Interventions

Sidestream capnography using the 'Respironics LoFlo Sidestream CO2 Module' DEVICE

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'.

INTELLiVENT-ASV with sidestream capnography

Mainstream capnography using the 'Respironics Capnostat 5 Mainstream CO2 sensor' DEVICE

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'.

INTELLiVENT-ASV with mainstream capnography

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC location AMC

Amsterdam, Netherlands

Location

Related Publications (1)

• Nijbroek SGLH, Roozeman JP, Ettayeby S, Rosenberg NM, van Meenen DMP, Cherpanath TGV, Lagrand WK, Tepaske R, Klautz RJM, Serpa Neto A, Schultz MJ. Closed-Loop ventilation using sidestream versus mainstream capnography for automated adjustments of minute ventilation-A randomized clinical trial in cardiac surgery patients. PLoS One. 2023 Aug 23;18(8):e0289412. doi: 10.1371/journal.pone.0289412. eCollection 2023.

  PMID: 37611007 DERIVED

Study Officials

• Marcus J. Schultz, Prof. dr.

  Amsterdam University Medical Centers location 'AMC'

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator and clinical professor

Model Details: INTELLiSTREAM is a single-center randomized clinical noninferiority trial

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 22, 2020
• Study Start: June 30, 2020
• Primary Completion: April 21, 2022
• Study Completion: May 21, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)