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

NCT ID: NCT04599491

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2022-05-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sidestream capnography using the 'Respironics LoFlo Sidestream CO2 Module'

Intervention Type: 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 mainstream capnography

Patients randomized into the 'Mainstream capnography'-arm will receive postoperative ventilation on the ICU with INTELLiVENT-ASV with mainstream etCO2 monitoring.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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'.

Interventions

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'.

Intervention Type: 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'.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Marcus J. Schultz

Principal investigator and clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcus J. Schultz, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam University Medical Centers location 'AMC'

Locations

Amsterdam UMC location AMC

Amsterdam, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 37611007 (View on PubMed)

Other Identifiers

INTELLiSTREAM

Identifier Type: -

Identifier Source: org_study_id