Clinical trial NCT02312869: Local Assessment of Management of Burn Patients
Official title: Local Assessment of Management of Burn Patients (LAMiNAR) - a Prospective Observational International Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns - Multiple
Mechanical Ventilation
Keywords: Mechanical Ventilation
Burn patients
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive intubated and ventilated burn patients admitted to participating ICUs during a period of 3 months

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.

Eligibility 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

Primary outcomes:
measure: Ventilation parameters
timeFrame: Up to 14 days during mechanical ventilation
measure: Ventilation parameters
timeFrame: Up to 14 days during mechanical ventilation
measure: Ventilation parameters
timeFrame: Up to 14 days during mechanical ventilation
measure: Ventilation parameters
timeFrame: Up to 14 days during mechanical ventilation
Secondary outcomes:
measure: Number of ventilator-free days and alive at day 28
timeFrame: From day 1 to day 28
measure: Other Ventilation Parameters
timeFrame: Up to 14 days during mechanical ventilation
measure: Other Ventilation Parameters
timeFrame: Up to 14 days during mechanical ventilation
measure: Other Ventilation Parameters
timeFrame: Up to 14 days during mechanical ventilation
measure: Other Ventilation Parameters
timeFrame: Up to 14 days during mechanical ventilation
measure: Other Ventilation Parameters
timeFrame: Up to 14 days during mechanical ventilation
measure: Length of Stay in ICU on Day 90
timeFrame: Until day 90
measure: Length of Stay in Hospital on Day 90
timeFrame: Until day 90
measure: All-cause ICU Mortality
timeFrame: Until day 90
measure: All-cause Hospital Mortality
timeFrame: Until day 90
measure: Need for Tracheostomy
timeFrame: daily up to 14 days from inclusion
measure: Daily Lung Injury Scores
timeFrame: Up to 14 days during mechanical ventilation
measure: Daily Sequential Organ Failure Assessment (SOFA)-scores
timeFrame: Daily up to 14 days from inclusion
measure: Complications
timeFrame: Daily up to 14 days from inclusion
measure: Complications
timeFrame: Daily up to 14 days from inclusion
measure: Complications
timeFrame: Daily up to 14 days from inclusion
measure: Complications
timeFrame: Daily up to 14 days from inclusion
measure: Complications
timeFrame: Daily up to 14 days from inclusion
measure: Complications
timeFrame: Daily up to 14 days from inclusion
Other outcomes:
measure: Standard care strategies
timeFrame: Daily up to 14 days from inclusion
measure: Standard care strategies
timeFrame: Daily up to 14 days from inclusion
measure: Standard care strategies
timeFrame: Daily up to 14 days from inclusion
measure: Standard care strategies
timeFrame: Daily up to 14 days from inclusion
measure: Standard care strategies
timeFrame: Daily up to 14 days from inclusion
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Zuid Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Marcus J. Schultz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schultz MJ, Horn J, Hollmann MW, Preckel B, Glas GJ, Colpaert K, Malbrain M, Neto AS, Asehnoune K, de Abreu MG, Martin-Loeches I, Pelosi P, Sjoberg F, Binnekade JM, Cleffken B, Juffermans NP, Knape P, Loef BG, Mackie DP, Enkhbaatar P, Depetris N, Perner A, Herrero E, Cachafeiro L, Jeschke M, Lipman J, Legrand M, Horter J, Lavrentieva A, Glas G, Kazemi A, Guttormsen AB, Huss F, Kol M, Wong H, Starr T, De Crop L, de Oliveira Filho W, Manoel Silva Junior J, Grion CMC, Jeschke MG, Burnett M, Mondrup F, Ravat F, Fontaine M, Asehoune K, Floch RL, Jeanne M, Bacus M, Chaussard M, Lehnhardt M, Mikhail BD, Gille J, Sharkey A, Trommel N, Reidinga AC, Vieleers N, Tilsley A, Onarheim H, Bouza MT, Agrifoglio A, Freden F, Palmieri T, Painting LE; LAMiNAR investigators. Ventilation practices in burn patients-an international prospective observational cohort study. Burns Trauma. 2021 Dec 16;9:tkab034. doi: 10.1093/burnst/tkab034. eCollection 2021.