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Individualised Weaning From Mechanical Ventilation in General ICU (iCareWean_CW)

Primary Purpose

Ventilatory Failure

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Beacon Caresystem

About this trial

This is an interventional treatment trial for Ventilatory Failure focused on measuring Weaning, Intensive Care, Individualised Care, Open-Loop Decision Support System, Respiratory Failure, Mechanical Ventilation, Spontaneous breathing Tests, Extubation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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].
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

Sites / Locations

The Magill Department of Anaesthesia, Chelsea and Westminster HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Beacon Caresystem

Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to spontaneous ventilation

It is defined as the time taken to wean from mandatory mode of ventilation

Time to extubation

It is defined as the time the decision is made to proceed with removal of the endotracheal tube or tracheal decannulation.

Full Information

NCT ID

NCT03249623

First Posted

June 22, 2017

Last Updated

July 20, 2020

Sponsor

Chelsea and Westminster NHS Foundation Trust

Collaborators

Aalborg University

1. Study Identification

Unique Protocol Identification Number

NCT03249623

Brief Title

Individualised Weaning From Mechanical Ventilation in General ICU

Acronym

iCareWean_CW

Official Title

Weaning From Mechanical Ventilation: Comparison of Open-Loop Decision Support System and Routine Care, in the General Intensive Care Unit

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 11, 2017 (Actual)

Primary Completion Date

November 30, 2020 (Anticipated)

Study Completion Date

July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chelsea and Westminster NHS Foundation Trust

Collaborators

Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventilatory Failure

Keywords

Weaning, Intensive Care, Individualised Care, Open-Loop Decision Support System, Respiratory Failure, Mechanical Ventilation, Spontaneous breathing Tests, Extubation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

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

Participant

Allocation

Randomized

Enrollment

274 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Beacon Caresystem

Arm Type

Experimental

Arm Description

Arm Title

Standard Care

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

Beacon Caresystem

Intervention Description

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.

Primary Outcome Measure Information:

Title

Length of mechanical ventilation

Description

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.

Secondary Outcome Measure Information:

Title

Time to spontaneous ventilation

Description

It is defined as the time taken to wean from mandatory mode of 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.

Title

Time to extubation

Description

It is defined as the time the decision is made to proceed with removal of the endotracheal tube or tracheal decannulation.

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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]. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Damon P Foster

Phone

+44 2033156887

Ext

56887

essam.ramhamadany@chelwest.nhs.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Stephen Rees, PhD

Phone

+45 30328469

sr@hst.aau.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcela P Vizcaychipi, MD PhD FFICM

Organizational Affiliation

Chelsea and Westminster NHS Foundation Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Magill Department of Anaesthesia, Chelsea and Westminster Hospital

City

London

ZIP/Postal Code

SW10 9NH

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

James R White, MBBS

Phone

+447539729847

James.white2@chelwest.nhs.uk

First Name & Middle Initial & Last Name & Degree

Margaret Smyth

Phone

+447584640699

Margaret.smyth@chelwest.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27930361

Citation

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.

Results Reference

result

PubMed Identifier

26737495

Citation

Rees 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 Reference

result

PubMed Identifier

25962614

Citation

Weinreich 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.

Results Reference

result

PubMed Identifier

32878764

Citation

Vizcaychipi 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. Erratum In: BMJ Open. 2020 Oct 23;10(10):e042145corr1.

Results Reference

derived

Links:

URL

http://www.chelwest.nhs.uk

Description

Sponsor website

Learn more about this trial

Individualised Weaning From Mechanical Ventilation in General ICU

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