Mechanical Ventilation ComplicationINTELLiSTREAMNCT04599491

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

A study testing Sidestream capnography using the 'Respironics LoFlo Sidestream CO2 Module' and Mainstream capnography using the 'Respironics Capnostat 5 Mainstream CO2 sensor' in people with Mechanical Ventilation Complication and Intensive Care Unit, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Mechanical Ventilation Complication, Intensive Care Unit, Postoperative Care
What is being tested?: Sidestream capnography using the 'Respironics LoFlo Sidestream CO2 Module' and Mainstream capnography using the 'Respironics Capnostat 5 Mainstream CO2 sensor'
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteNetherlands
Study dates: 30 Jun 2020to 21 May 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Amsterdam UMC location AMC
Amsterdam

Other trials in Netherlands

About this study

Official title: 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

Conditions: Mechanical Ventilation Complication, Intensive Care Unit, Postoperative Care
Being tested: Sidestream capnography using the 'Respironics LoFlo Sidestream CO2 Module', Mainstream capnography using the 'Respironics Capnostat 5 Mainstream CO2 sensor'
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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'.
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'.

Study groups in NCT04599491
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Mainstream capnography using the 'Respironics Capnostat 5 Mainstream CO2 sensor'

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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.
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%.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: During first 5 postoperative days days.
Length of stay in ICU
Measured: From admission to ICU to ICU discharge of the patient, assessed up to 30 days.
Readmission to ICU
Measured: From admission to ICU to hospital discharge of the patient, assessed up to 30 days.
Mortality in the ICU
Measured: 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.
Measured: 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%.
Measured: 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)
Measured: 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)
Measured: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Ventilation parameters: respiratory rate
Respiratory rate (RR)
Measured: 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)
Measured: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Ventilation parameters: capnography
End-tidal CO2 (etCO2)
Measured: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Clinically indicated arterial blood gas analyses
Measured: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202021 May 2022

First posted22 Oct 2020
Study start30 Jun 2020
Primary completion21 Apr 2022
Study completion21 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: INTELLiSTREAM is a single-center randomized clinical noninferiority trial
Masking: Single blind
Who is masked: Participant
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04599491
Sponsor's protocol ID: INTELLiSTREAM
Acronym: INTELLiSTREAM
Status last verified: Jul 2022
First submitted: 6 Oct 2020
Last updated: 6 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD sharing plan will follow

Publications

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.
PubMed 37611007

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: INTELLiVENT-ASV Using Mainstream Versus Sidestream End-Tidal CO2 Monitoring- a Randomized Noninferiority Clinical Trial in Cardiac Surgery Patients
ClinicalTrials.gov ID: NCT04599491
Acronym / sponsor ID: INTELLiSTREAM / INTELLiSTREAM
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
Study start: 30 Jun 2020 (actual)
Primary completion: 21 Apr 2022 (actual)
Study completion: 21 May 2022 (actual)
First posted: 22 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Background

Objective of the study

Hypothesis

Study design

INTELLiSTREAM is a randomized noninferiority study.

Study population

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

Secondary outcomes

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: INTELLiSTREAM is a single-center randomized clinical noninferiority trial

Arm	Type	Receives
INTELLiVENT-ASV with sidestream capnography	Experimental	Device: Sidestream capnography using the 'Respironics LoFlo Sidestream CO2 Module'Patients randomized into the 'Sidestream capnography'-arm will receive postoperative ventilation on the ICU with INTELLiVENT-ASV with sidestream etCO2 monitoring.
INTELLiVENT-ASV with mainstream capnography	Active comparator	Device: Mainstream capnography using the 'Respironics Capnostat 5 Mainstream CO2 sensor'Patients randomized into the 'Mainstream capnography'-arm will receive postoperative ventilation on the ICU with INTELLiVENT-ASV with mainstream etCO2 monitoring.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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'.	Device	INTELLiVENT-ASV with sidestream capnography
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'.	Device	INTELLiVENT-ASV with mainstream capnography

Primary outcome

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)

17 secondary outcomes

The percentage (%) of time spent in the 'optimal', 'acceptable' and 'critical' zones during the first 3 hours of postoperative ventilation using INTELLiVENT-ASV.
Time frame: During the first 3 hours, since admission on the ICU with the start of the INTELLiVENT-ASV ventilation mode.
Time to spontaneous breathing
Time frame: Time from start of ventilation at the ICU until five or more consecutive spontaneous breaths, assessed up to 30 days.
Duration of weaning
Time frame: 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 frame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Proportion of failed extubations
Time frame: Within 48 hours after extubation.
Development of postoperative pulmonary complications
Time frame: During first 5 postoperative days days.
Length of stay in ICU
Time frame: From admission to ICU to ICU discharge of the patient, assessed up to 30 days.
Readmission to ICU
Time frame: From admission to ICU to hospital discharge of the patient, assessed up to 30 days.
Mortality in the ICU
Time frame: From admission to ICU to ICU discharge of the patient, assessed up to 30 days.
Loss of capnography signal
Time frame: During the first 3 hours, since admission on the ICU with the start of INTELLiVENT-ASV ventilation mode.
Incidence of hypoxemia
Time frame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Ventilatory parameters: pressures
Time frame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Ventilation parameters: volumes
Time frame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Ventilation parameters: respiratory rate
Time frame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Ventilation parameters: oxygenation
Time frame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Ventilation parameters: capnography
Time frame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.
Clinically indicated arterial blood gas analyses
Time frame: Time from start of ventilation at the ICU until tracheal extubation, assessed up to 30 days.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
Derived from this study: PubMed 37611007Nijbroek 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.
Individual participant dataSharing planned: Yes. IPD sharing plan will follow

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marcus J. Schultz, Prof. dr. principal investigator

Amsterdam University Medical Centers location 'AMC'

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04599491, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.