Ventilatory FailureiCareWean_CWNCT03249623
Individualised Weaning From Mechanical Ventilation in General ICU
A study testing Beacon Caresystem in people with Ventilatory Failure, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Patients residing in the intensive care unit typically receive mechanical ventilatory support. Selecting the appropriate level of mechanical ventilation is not trivial, and it has been shown that lung protective settings can reduce mortality in patients with lung injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilatory Failure
- What is being tested?
- Beacon Caresystem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Dec 2017to 30 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is expected to be on invasive mechanical ventilation more 24 hours.
- Age > 18 years
- Haemodynamically stable (with instability defined by the presence of two or more of the following criteria: acidosis pH < 7.2, poor urine output < 0.5ml/kg, use of vasopressors, e.g. noradrenline > 25 μg/min).
- Patient consent or, in the case that the patient is unable, assent from the next of kin or treating physician following understanding and accept of oral and written information describing the study
Who cannot join
- The absence of an arterial catheter for blood sampling at study start.
- Medical history of home mechanical ventilation which may lead to prolonged stay in the ICU, including long term oxygen therapy and non-invasive ventilation not associated with sleep apnoa.
- Clinical conditions requiring treatment with extracorporeal membrane oxygenation, i.e. an inspired oxygen of 100% for more than 24 hours.
- Head trauma or other conditions where intra-cranial pressure may be elevated and tight regulation of arterial CO2 level is paramount.
- Primary neurological patients (Glasgow coma score <10, neurologic damage with limited prognosis, stroke hemiplegia).
- Severe heart failure, classified as grade 4 of the Association of Cardiology guidelines [2].
Show all 13Show fewer
- End stage liver disease.
- Multiple medical ICU admissions, i.e. more than one admission.
- Corrective orthognathic surgery.
- Esophageal surgery.
- Morbidly obese patients defined as either BMI>45, or 35<BMI<45 with APACHEII score on admission greater than 24.
- Pregnancy.
- Mechanical ventilation initiated for more for 24 hours in other centers
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Magill Department of Anaesthesia, Chelsea and Westminster Hospital
London, SW10 9NH
James R White, MBBS, +447539729847, James.white2@chelwest.nhs.uk
Margaret Smyth, +447584640699, Margaret.smyth@chelwest.nhs.uk
About this study
Official title: Weaning From Mechanical Ventilation: Comparison of Open-Loop Decision Support System and Routine Care, in the General Intensive Care Unit
Patients residing in the intensive care unit typically receive mechanical ventilatory support. Selecting the appropriate level of mechanical ventilation is not trivial, and it has been shown that lung protective settings can reduce mortality in patients with lung injury. Despite being a life- saving therapy, duration of mechanical ventilation should be kept at a minimum to reduce effects of immobilization, long-term sedation, patient discomfort, risk of ventilator associated pneumonia, leading to decreasing mortality and economic costs etc. The duration of mechanical ventilation is also an important factor in weaning from ventilatory support, with prolonged ventilator support making the weaning process more difficult.
The purpose of this study is to compare mechanical ventilation following advice from the Beacon Caresystem to that of standard care in general medical intensive care unit (ICU) patients, from the start of requiring invasive mechanical ventilation until successful extubation. The Beacon Caresystem will be compared to standard care to investigate whether use of the system results in similar care or reduced time for weaning from mechanical ventilation.
Read the detailed description
All patients admitted to the ICU with mechanical ventilation are screened for inclusion. Patients receiving invasive mechanical ventilation (≥ 24 h) will be considered for inclusion in the study on a daily basis. Patient screening will be performed by clinical researchers or a delegated clinician and consent/assent will be sought. Then patients will be randomised to the Beacon group or Standard Care group. Randomisation will be performed using sealed envelopes, and in blocks of patients, allowing interim analysis of results in appropriate steps during the study. To avoid that results are affected by patient disease type, randomisation will be stratified for equal distribution between randomisation groups.
Patients will be randomly assigned to either standard care of mechanical ventilation, or to follow the advice of the Beacon Caresystem. The results of these two strategies will then be compared based upon the following outcome measurements.
- Conditions
- Ventilatory Failure
- Being tested
- Beacon Caresystem
- Keywords
- Weaning, Intensive Care, Individualised Care, Open-Loop Decision Support System, Respiratory Failure, Mechanical Ventilation, Spontaneous breathing Tests, Extubation
- Medical subject headings
- Hypoventilation, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beacon CaresystemDevice
The core of the system is a set of physiological models including pulmonary gas exchange, acid-base chemistry, lung mechanics, and respiratory drive. The Beacon Caresystem tunes these models to the individual patient such that they describe accurately current measurements. Once tuned, the models are used by the system to simulate the effects of changing ventilator settings. The results of these simulations are then used calculate the clinical benefit of changing ventilator settings by balancing the competing goals of mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Beacon Caresystem | Experimental | On randomisation to the Beacon group, a Beacon Caresystem will be connected to the patient. This involves connecting a pulse oximeter to the patient's finger (toe or ear) to measure pulse oximetry oxygen saturation and pulse, and placing a standard clinical respiratory gas analysis and flow sensor in the respiratory tubing connecting the ventilator to the patient. This sensor allows measurement of respiratory pressure, flow and volume; plus respiratory gas CO2 and O2. Receives: Device: Beacon Caresystem |
| Standard Care | No intervention | For this group mechanical ventilation is managed according to standard care. A Beacon CareSystem will be connected to the patient, as for the Beacon Randomisation group, but the system will be used solely for data collection, and advice will be disabled. Physiological variables captured in this arm of the study will mirror the intervention arm. Decision relating to weaning, extubation, reintubation and sedation including level of seniority of personnel involved in the decision tree process will be documented accordingly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of mechanical ventilation
Length of mechanical ventilation, defined as either the time of intubation in the ICU, or the time of admission to the ICU following previous intubation for surgery, and until successful extubation, with successful
Measured: Daily assessment of requirement of mechanical ventilation from the time of randomisation until the date of liberation from mechanical ventilation, up to 12 months.
Secondary outcomes (2)
Time to spontaneous ventilation
It is defined as the time taken to wean from mandatory mode of ventilation
Measured: Daily assessment of spontaneous ventilation from the date of randomisation until the date the patient starts breathing spontaneously, up to 12 months.
Time to extubation
It is defined as the time the decision is made to proceed with removal of the endotracheal tube or tracheal decannulation.
Measured: Daily assessment of time to extubation from the date of initiation of spontaneous ventilation until the date of liberation from mechanical ventilation, up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start11 Dec 2017
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ventilatory FailureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- After randomisation, for patients randomised in the Beacon group, the Beacon system will actively advice clinicians on ventilatory settings to adapt the ventilator to patient's individual clinical situation and corresponding clinical intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Sponsor
- Investigators
- Marcela P Vizcaychipi, MD PhD FFICM, Principal investigator, Chelsea and Westminster NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249623
- Sponsor's protocol ID
- 226610
- Other IDs
- 2017-002627-25, 2017
- Acronym
- iCareWean_CW
- Status last verified
- Jul 2020
- First submitted
- 22 Jun 2017
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rees SE, Karbing DS. Determining the appropriate model complexity for patient-specific advice on mechanical ventilation. Biomed Tech (Berl). 2017 Apr 1;62(2):183-198. doi: 10.1515/bmt-2016-0061.
PubMed 27930361Rees SE, Karbing DS. Model-based advice for mechanical ventilation: From research (INVENT) to product (Beacon Caresystem). Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:5331-4. doi: 10.1109/EMBC.2015.7319595.
PubMed 26737495Weinreich UM, Thomsen LP, Rees SE, Rasmussen BS. The effects of oxygen induced pulmonary vasoconstriction on bedside measurement of pulmonary gas exchange. J Clin Monit Comput. 2016 Apr;30(2):207-14. doi: 10.1007/s10877-015-9703-x. Epub 2015 May 12.
PubMed 25962614Vizcaychipi MP, Karbing DS, Martins L, Gupta A, Moreno-Cuesta J, Naik M, Welters I, Singh S, Randell G, Osman L, Rees SE. Evaluation of decision support to wean patients from mechanical ventilation in intensive care: a prospective study reporting clinical and physiological outcomes. J Clin Monit Comput. 2025 Apr;39(2):393-404. doi: 10.1007/s10877-024-01231-5. Epub 2024 Nov 9.
PubMed 39520605Vizcaychipi MP, Martins L, White JR, Karbing DS, Gupta A, Singh S, Osman L, Moreno-Cuesta J, Rees S. Intensive Care Weaning (iCareWean) protocol on weaning from mechanical ventilation: a single-blinded multicentre randomised control trial comparing an open-loop decision support system and routine care, in the general intensive care unit. BMJ Open. 2020 Sep 2;10(9):e042145. doi: 10.1136/bmjopen-2020-042145.
PubMed 32878764
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning From Mechanical Ventilation: Comparison of Open-Loop Decision Support System and Routine Care, in the General Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03249623
- Acronym / sponsor ID
- iCareWean_CW / 226610
- Conditions
- Ventilatory Failure
- Keywords
- Weaning, Intensive Care, Individualised Care, Open-Loop Decision Support System, Respiratory Failure, Mechanical Ventilation, Spontaneous breathing Tests, Extubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 15 Aug 2017 (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.
Patients residing in the intensive care unit typically receive mechanical ventilatory support. Selecting the appropriate level of mechanical ventilation is not trivial, and it has been shown that lung protective settings can reduce mortality in patients with lung injury. Despite being a life- saving therapy, duration of mechanical ventilation should be kept at a minimum to reduce effects of immobilization, long-term sedation, patient discomfort, risk of ventilator associated pneumonia, leading to decreasing mortality and economic costs etc. The duration of mechanical ventilation is also an important factor in weaning from ventilatory support, with prolonged ventilator support making the weaning process more difficult.
The purpose of this study is to compare mechanical ventilation following advice from the Beacon Caresystem to that of standard care in general medical intensive care unit (ICU) patients, from the start of requiring invasive mechanical ventilation until successful extubation. The Beacon Caresystem will be compared to standard care to investigate whether use of the system results in similar care or reduced time for weaning from mechanical ventilation.
Detailed description
All patients admitted to the ICU with mechanical ventilation are screened for inclusion. Patients receiving invasive mechanical ventilation (≥ 24 h) will be considered for inclusion in the study on a daily basis. Patient screening will be performed by clinical researchers or a delegated clinician and consent/assent will be sought. Then patients will be randomised to the Beacon group or Standard Care group. Randomisation will be performed using sealed envelopes, and in blocks of patients, allowing interim analysis of results in appropriate steps during the study. To avoid that results are affected by patient disease type, randomisation will be stratified for equal distribution between randomisation groups.
Patients will be randomly assigned to either standard care of mechanical ventilation, or to follow the advice of the Beacon Caresystem. The results of these two strategies will then be compared based upon the following outcome measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- After randomisation, for patients randomised in the Beacon group, the Beacon system will actively advice clinicians on ventilatory settings to adapt the ventilator to patient's individual clinical situation and corresponding clinical intervention.
| Arm | Type | Receives |
|---|---|---|
| Beacon Caresystem | Experimental | Device: Beacon CaresystemOn randomisation to the Beacon group, a Beacon Caresystem will be connected to the patient. This involves connecting a pulse oximeter to the patient's finger (toe or ear) to measure pulse oximetry oxygen saturation and pulse, and placing a standard clinical respiratory gas analysis and flow sensor in the respiratory tubing connecting the ventilator to the patient. This sensor allows measurement of respiratory pressure, flow and volume; plus respiratory gas CO2 and O2. |
| Standard Care | No intervention | –For this group mechanical ventilation is managed according to standard care. A Beacon CareSystem will be connected to the patient, as for the Beacon Randomisation group, but the system will be used solely for data collection, and advice will be disabled. Physiological variables captured in this arm of the study will mirror the intervention arm. Decision relating to weaning, extubation, reintubation and sedation including level of seniority of personnel involved in the decision tree process will be documented accordingly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is expected to be on invasive mechanical ventilation more 24 hours.
- Age > 18 years
- Haemodynamically stable (with instability defined by the presence of two or more of the following criteria: acidosis pH < 7.2, poor urine output < 0.5ml/kg, use of vasopressors, e.g. noradrenline > 25 μg/min).
- Patient consent or, in the case that the patient is unable, assent from the next of kin or treating physician following understanding and accept of oral and written information describing the study
Key exclusion criteria (13 listed)
- The absence of an arterial catheter for blood sampling at study start.
- Medical history of home mechanical ventilation which may lead to prolonged stay in the ICU, including long term oxygen therapy and non-invasive ventilation not associated with sleep apnoa.
- Clinical conditions requiring treatment with extracorporeal membrane oxygenation, i.e. an inspired oxygen of 100% for more than 24 hours.
- Head trauma or other conditions where intra-cranial pressure may be elevated and tight regulation of arterial CO2 level is paramount.
- Primary neurological patients (Glasgow coma score <10, neurologic damage with limited prognosis, stroke hemiplegia).
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 |
|---|---|---|
| Beacon CaresystemThe core of the system is a set of physiological models including pulmonary gas exchange, acid-base chemistry, lung mechanics, and respiratory drive. The Beacon Caresystem tunes these models to the individual patient such that they describe accurately current measurements. Once tuned, the models are used by the system to simulate the effects of changing ventilator settings. The results of these simulations are then used calculate the clinical benefit of changing ventilator settings by balancing the competing goals of mechanical ventilation. | Device | Beacon Caresystem |
Primary outcome
Length of mechanical ventilation
Time frame: Daily assessment of requirement of mechanical ventilation from the time of randomisation until the date of liberation from mechanical ventilation, up to 12 months.
Length of mechanical ventilation, defined as either the time of intubation in the ICU, or the time of admission to the ICU following previous intubation for surgery, and until successful extubation, with successful
2 secondary outcomes
Time to spontaneous ventilation
Time frame: Daily assessment of spontaneous ventilation from the date of randomisation until the date the patient starts breathing spontaneously, up to 12 months.
Time to extubation
Time frame: Daily assessment of time to extubation from the date of initiation of spontaneous ventilation until the date of liberation from mechanical ventilation, up to 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Results publication: PubMed 27930361Rees SE, Karbing DS. Determining the appropriate model complexity for patient-specific advice on mechanical ventilation. Biomed Tech (Berl). 2017 Apr 1;62(2):183-198. doi: 10.1515/bmt-2016-0061.
- Results publication: PubMed 26737495Rees SE, Karbing DS. Model-based advice for mechanical ventilation: From research (INVENT) to product (Beacon Caresystem). Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:5331-4. doi: 10.1109/EMBC.2015.7319595.
- Results publication: PubMed 25962614Weinreich UM, Thomsen LP, Rees SE, Rasmussen BS. The effects of oxygen induced pulmonary vasoconstriction on bedside measurement of pulmonary gas exchange. J Clin Monit Comput. 2016 Apr;30(2):207-14. doi: 10.1007/s10877-015-9703-x. Epub 2015 May 12.
- Derived from this study: PubMed 39520605Vizcaychipi MP, Karbing DS, Martins L, Gupta A, Moreno-Cuesta J, Naik M, Welters I, Singh S, Randell G, Osman L, Rees SE. Evaluation of decision support to wean patients from mechanical ventilation in intensive care: a prospective study reporting clinical and physiological outcomes. J Clin Monit Comput. 2025 Apr;39(2):393-404. doi: 10.1007/s10877-024-01231-5. Epub 2024 Nov 9.
- Derived from this study: PubMed 32878764Vizcaychipi MP, Martins L, White JR, Karbing DS, Gupta A, Singh S, Osman L, Moreno-Cuesta J, Rees S. Intensive Care Weaning (iCareWean) protocol on weaning from mechanical ventilation: a single-blinded multicentre randomised control trial comparing an open-loop decision support system and routine care, in the general intensive care unit. BMJ Open. 2020 Sep 2;10(9):e042145. doi: 10.1136/bmjopen-2020-042145.
- Details of the Beacon SystemLink provided by the sponsor.
- Sponsor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Ventilatory Failure
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Recruiting
HFNC Versus NIV in Hypercapneic COPD Patients
COPD (Chronic Obstructive Pulmonary Disease)
Recruiting
Effects of Controlled Breathing Added to Therapeutic Exercise in Multiple Myeloma
Multiple Myeloma, Breathing Techniques
Recruiting
Effects of Controlled Breathing on Cardiorespiratory Variables in Multiple Myeloma
Multiple Myeloma (MM), Breathing Techniques
Recruiting
The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia
Ventilatory Depression, Postoperative Respiratory Failure
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.
Marcela P Vizcaychipi, MD PhD FFICM principal investigator
Chelsea and Westminster NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beacon Caresystem in people with Ventilatory Failure, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 21 Jul 2020. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damon P Foster (+44 2033156887 ext. 56887, essam.ramhamadany@chelwest.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of mechanical ventilation (time frame: Daily assessment of requirement of mechanical ventilation from the time of randomisation until the date of liberation from mechanical ventilation, up to 12 months.). 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 NCT03249623, which also lists 5 linked publications.
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 21 Jul 2020.