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Completed

NCT Number: NCT02312869

Local Assessment of Management of Burn Patients

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.

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Key information

Conditions

Burns - Multiple Mechanical Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Medical Center

Amsterdam, South Holland, 1105AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

not applicable, observational study

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

Local Assessment of Management of Burn Patients (LAMiNAR) - a Prospective Observational International Multicenter Cohort Study

Acronym: LAMiNAR

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2014
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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