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Trial record 2 of 5 for:    weaning open loop

Individualised Weaning From Mechanical Ventilation in General ICU (iCareWean_CW)

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ClinicalTrials.gov Identifier: NCT03249623
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
Chelsea and Westminster NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Ventilatory Failure Device: Beacon Caresystem Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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 (Participant)
Primary Purpose: Treatment
Official Title: Weaning From Mechanical Ventilation: Comparison of Open‐Loop Decision Support System and Routine Care, in the General Intensive Care Unit
Actual Study Start Date : December 11, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : August 30, 2019

Arm Intervention/treatment
Experimental: Beacon Caresystem
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.
Device: Beacon Caresystem
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.

No Intervention: Standard Care
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. ]
    It is defined as the time taken to wean from mandatory mode of ventilation

  2. 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. ]
    It is defined as the time the decision is made to proceed with removal of the endotracheal tube or tracheal decannulation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249623


Contacts
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Contact: Damon P Foster +44 2033156887 ext 56887 essam.ramhamadany@chelwest.nhs.uk
Contact: Stephen Rees, PhD +45 30328469 sr@hst.aau.dk

Locations
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United Kingdom
The Magill Department of Anaesthesia, Chelsea and Westminster Hospital Recruiting
London, United Kingdom, SW10 9NH
Contact: James R White, MBBS    +447539729847    James.white2@chelwest.nhs.uk   
Contact: Margaret Smyth    +447584640699    Margaret.smyth@chelwest.nhs.uk   
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
Aalborg University
Investigators
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Principal Investigator: Marcela P Vizcaychipi, MD PhD FFICM Chelsea and Westminster Hospital NHS Foundation Trust

Additional Information:
Publications of Results:
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Responsible Party: Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03249623     History of Changes
Other Study ID Numbers: 226610
2017-002627-25 ( EudraCT Number )
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Chelsea and Westminster NHS Foundation Trust:
Weaning
Intensive Care
Individualised Care
Open-Loop Decision Support System
Respiratory Failure
Mechanical Ventilation
Spontaneous breathing Tests
Extubation
Additional relevant MeSH terms:
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Hypoventilation
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms