Local Assessment of Management of Burn Patients
- Conditions
- Burns - MultipleMechanical Ventilation
- Registration Number
- NCT02312869
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Burns
- Admission to a participating burn ICU Need for invasive ventilation
- Informed consent (only if applicable in the country where data are collected)
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ventilation parameters Up to 14 days during mechanical ventilation Mode of ventilation; assist-control or spontaneous modes of ventilation
- Secondary Outcome Measures
Name Time Method Number of ventilator-free days and alive at day 28 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'
All-cause ICU Mortality Until day 90 Any death during ICU stay
Other Ventilation Parameters Up to 14 days during mechanical ventilation Arterial blood gas parameters
Length of Stay in ICU on Day 90 Until day 90 Time between admission and discharge or death
Need for Tracheostomy daily up to 14 days from inclusion Need for tracheostomy, first tracheostomy will be assessed up to 14 days from inclusion
Length of Stay in Hospital on Day 90 Until day 90 Time between admission and discharge or death
Daily Lung Injury Scores Up to 14 days during mechanical ventilation Score based on chest X-ray findings (if obtained), PaO2/FiO2, PEEP level and respiratory compliance.
Complications Daily up to 14 days from inclusion Complications will include: Abdominal compartment syndrome
All-cause Hospital Mortality Until day 90 Any death during hospital stay
Daily Sequential Organ Failure Assessment (SOFA)-scores Daily up to 14 days from inclusion six-organ dysfunction/failure score measuring multiple organ failure daily
Trial Locations
- Locations (1)
Academic Medical Center
🇳🇱Amsterdam, Zuid Holland, Netherlands