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Local Assessment of Management of Burn Patients (LAMiNAR)

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ClinicalTrials.gov Identifier: NCT02312869
Recruitment Status : Completed
First Posted : December 9, 2014
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:

In the general intensive care unit (ICU) population, there is strong evidence for benefit from lung-protective mechanical ventilation, including the use of low tidal volumes and adequate levels of positive end-expiratory pressure (PEEP). In burn patients it is highly uncertain whether these settings are beneficial and there are even concerns over safety of, in particular use of low tidal volumes. There is lack of international guidelines and consequently ventilation practice in burn patients may widely vary.

The primary objective is to determine ventilation practice in burn ICUs worldwide, focusing on the size of tidal volumes and the levels of PEEP used for burn patients. In addition, data on other strategies considered important in patients who receive ventilation are also collected, including data on neuromuscular blocking agents, sedatives and analgesics, and type and amount of intravenous fluids used in the period of ventilation. The secondary objective is to determine the association between tidal volume size and levels of PEEP, and duration of ventilation in burn patients.


Condition or disease Intervention/treatment
Burns - Multiple Mechanical Ventilation Other: No intervention

Detailed Description:

Patient population: Consecutive burn patients admitted to participating burn ICUs who receive invasive ventilation, irrespective of severity of burn injury and/or presence of inhalation trauma are eligible for participation.

Data collection: includes burn patients admitted within a period of three months. Demographic and baseline data are collected from the clinical files on the day of admission. If available, standard of care and clinical outcome parameters are collected daily until day 14, death or discharge from ICU, whatever comes first.

Sample size: The primary objective is to determine (variations in) ventilation practice in burn patients in burn ICUs. Therefore, the sample size is based on the main secondary objective, which is to determine the association between the following ventilator settings: tidal volume, PEEP, FiO2 and mode; and outcome of burn patients. The investigators calculated the sample size for a multiple regression model: a sample size of at least 300 patients is required to have a power of 0.80, a significance level of 0.05, using an estimated effect size of 0.04, while using 4 independent variables in the model.

Ethics Approval: National coordinators will be responsible for clarifying the need for ethics approval and applying for this where appropriate according to local policy. Centres will not be permitted to record data unless ethics approval or an equivalent waiver is in place. The investigators expect that in most, if not every participating country, a patient informed consent is not be required.

Monitoring: Due to the observational nature of the study, a DSMB is not necessary.

Organization: National co-ordinators will lead the project within individual nations and identify participating hospitals, translate study paperwork, distribute study paperwork and ensure necessary regulatory approvals are in place. They provide assistance to the participating clinical sites in trial management, record keeping and data management. Local coordinators in each site will supervise data collection and ensure adherence to Good Clinical Practice during the trial.

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Local Assessment of Management of Burn Patients (LAMiNAR) - a Prospective Observational International Multicenter Cohort Study
Study Start Date : September 2015
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns


Intervention Details:
  • Other: No intervention
    not applicable, observational study


Primary Outcome Measures :
  1. Ventilation parameters [ Time Frame: Up to 14 days during mechanical ventilation ]
    Tidal volume size; milliliters per kilogram of predicted body weight

  2. Ventilation parameters [ Time Frame: Up to 14 days during mechanical ventilation ]
    Level of positive end-expiratory pressure (PEEP); cm H2O

  3. Ventilation parameters [ Time Frame: Up to 14 days during mechanical ventilation ]
    Fraction of oxygen in inspired air (FiO2), %

  4. Ventilation parameters [ Time Frame: Up to 14 days during mechanical ventilation ]
    Mode of ventilation; assist-control or spontaneous modes of ventilation


Secondary Outcome Measures :
  1. Number of ventilator-free days and alive at day 28 [ Time Frame: From day 1 to day 28 ]
    Defined as the number of days, from day 1 to day 28, the patient is alive and breathes without assistance of a mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours. Notably, if after successful withdrawal of mechanical ventilation the patient requires ventilation for a surgical procedure, this will not count as a 'ventilator day'. If ventilation is prolonged after surgery due to respiratory insufficiency, the day(s) ventilation is required counts as a 'ventilator day'

  2. Other Ventilation Parameters [ Time Frame: Up to 14 days during mechanical ventilation ]
    Peak and plateau pressures or maximum airway pressure

  3. Other Ventilation Parameters [ Time Frame: Up to 14 days during mechanical ventilation ]
    Respiratory rate

  4. Other Ventilation Parameters [ Time Frame: Up to 14 days during mechanical ventilation ]
    Inspiration to expiration ratio

  5. Other Ventilation Parameters [ Time Frame: Up to 14 days during mechanical ventilation ]
    Peripheral oxygen saturation

  6. Other Ventilation Parameters [ Time Frame: Up to 14 days during mechanical ventilation ]
    Arterial blood gas parameters

  7. Length of Stay in ICU on Day 90 [ Time Frame: Until day 90 ]
    Time between admission and discharge or death

  8. Length of Stay in Hospital on Day 90 [ Time Frame: Until day 90 ]
    Time between admission and discharge or death

  9. All-cause ICU Mortality [ Time Frame: Until day 90 ]
    Any death during ICU stay

  10. All-cause Hospital Mortality [ Time Frame: Until day 90 ]
    Any death during hospital stay

  11. Need for Tracheostomy [ Time Frame: daily up to 14 days from inclusion ]
    Need for tracheostomy, first tracheostomy will be assessed up to 14 days from inclusion

  12. Daily Lung Injury Scores [ Time Frame: Up to 14 days during mechanical ventilation ]
    Score based on chest X-ray findings (if obtained), PaO2/FiO2, PEEP level and respiratory compliance.

  13. Daily Sequential Organ Failure Assessment (SOFA)-scores [ Time Frame: Daily up to 14 days from inclusion ]
    six-organ dysfunction/failure score measuring multiple organ failure daily

  14. Complications [ Time Frame: Daily up to 14 days from inclusion ]
    Complications will include: Skin and soft tissue infections

  15. Complications [ Time Frame: Daily up to 14 days from inclusion ]
    Complications will include: (Ventilator associated) Pneumonia

  16. Complications [ Time Frame: Daily up to 14 days from inclusion ]
    Complications will include: Sepsis

  17. Complications [ Time Frame: Daily up to 14 days from inclusion ]
    Complications will include: Acute respiratory distress syndrome according to Berlin criteria

  18. Complications [ Time Frame: Daily up to 14 days from inclusion ]
    Complications will include: Acute renal failure

  19. Complications [ Time Frame: Daily up to 14 days from inclusion ]
    Complications will include: Abdominal compartment syndrome


Other Outcome Measures:
  1. Standard care strategies [ Time Frame: Daily up to 14 days from inclusion ]
    Strategies considered to be important in patients who receive ventilation, including: Fluid balance, types and dose of fluids used

  2. Standard care strategies [ Time Frame: Daily up to 14 days from inclusion ]
    Strategies considered to be important in patients who receive ventilation, including: use of sedative and analgesic drugs

  3. Standard care strategies [ Time Frame: Daily up to 14 days from inclusion ]
    Strategies considered to be important in patients who receive ventilation, including: use of sedation and delirium scores

  4. Standard care strategies [ Time Frame: Daily up to 14 days from inclusion ]
    Strategies considered to be important in patients who receive ventilation, including: use of neuromuscular blocking agents

  5. Standard care strategies [ Time Frame: Daily up to 14 days from inclusion ]
    Strategies considered to be important in patients who receive ventilation, including: use of antibiotic prophylaxis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive intubated and ventilated burn patients admitted to participating ICUs during a period of 3 months
Criteria

Inclusion Criteria:

  • Burns
  • Admission to a participating burn ICU Need for invasive ventilation
  • Informed consent (only if applicable in the country where data are collected)

Exclusion Criteria:

  • None

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): NCT02312869


Locations
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Netherlands
Academic Medical Center
Amsterdam, Zuid Holland, Netherlands, 1105AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Marcus J. Schultz, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Additional Information:
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Responsible Party: Prof. Dr. Marcus J. Schultz, Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02312869    
Other Study ID Numbers: LAMiNAR
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Keywords provided by Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Mechanical Ventilation
Burn patients
Additional relevant MeSH terms:
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Burns
Wounds and Injuries