Local Assessment of Management of Burn Patients (LAMiNAR)

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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation; Burns - Multiple
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Amsterdam, Zuid Holland, Netherlands, 1105AZ
      • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive intubated and ventilated burn patients admitted to participating ICUs during a period of 3 months

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation parameters	Tidal volume size; milliliters per kilogram of predicted body weight	Up to 14 days during mechanical ventilation
Ventilation parameters	Level of positive end-expiratory pressure (PEEP); cm H2O	Up to 14 days during mechanical ventilation
Ventilation parameters	Fraction of oxygen in inspired air (FiO2), %	Up to 14 days during mechanical ventilation
Ventilation parameters	Mode of ventilation; assist-control or spontaneous modes of ventilation	Up to 14 days during mechanical ventilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay in ICU on Day 90	Time between admission and discharge or death	Until day 90
Length of Stay in Hospital on Day 90	Time between admission and discharge or death	Until day 90
All-cause ICU Mortality	Any death during ICU stay	Until day 90
All-cause Hospital Mortality	Any death during hospital stay	Until day 90
Number of ventilator-free days and alive at 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'	From day 1 to day 28
Other Ventilation Parameters	Peak and plateau pressures or maximum airway pressure	Up to 14 days during mechanical ventilation
Other Ventilation Parameters	Respiratory rate	Up to 14 days during mechanical ventilation
Other Ventilation Parameters	Inspiration to expiration ratio	Up to 14 days during mechanical ventilation
Other Ventilation Parameters	Peripheral oxygen saturation	Up to 14 days during mechanical ventilation
Other Ventilation Parameters	Arterial blood gas parameters	Up to 14 days during mechanical ventilation
Need for Tracheostomy	Need for tracheostomy, first tracheostomy will be assessed up to 14 days from inclusion	daily up to 14 days from inclusion
Daily Lung Injury Scores	Score based on chest X-ray findings (if obtained), PaO2/FiO2, PEEP level and respiratory compliance.	Up to 14 days during mechanical ventilation
Daily Sequential Organ Failure Assessment (SOFA)-scores	six-organ dysfunction/failure score measuring multiple organ failure daily	Daily up to 14 days from inclusion
Complications	Complications will include: Skin and soft tissue infections	Daily up to 14 days from inclusion
Complications	Complications will include: (Ventilator associated) Pneumonia	Daily up to 14 days from inclusion
Complications	Complications will include: Sepsis	Daily up to 14 days from inclusion
Complications	Complications will include: Acute respiratory distress syndrome according to Berlin criteria	Daily up to 14 days from inclusion
Complications	Complications will include: Acute renal failure	Daily up to 14 days from inclusion
Complications	Complications will include: Abdominal compartment syndrome	Daily up to 14 days from inclusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard care strategies	Strategies considered to be important in patients who receive ventilation, including: Fluid balance, types and dose of fluids used	Daily up to 14 days from inclusion
Standard care strategies	Strategies considered to be important in patients who receive ventilation, including: use of sedative and analgesic drugs	Daily up to 14 days from inclusion
Standard care strategies	Strategies considered to be important in patients who receive ventilation, including: use of sedation and delirium scores	Daily up to 14 days from inclusion
Standard care strategies	Strategies considered to be important in patients who receive ventilation, including: use of neuromuscular blocking agents	Daily up to 14 days from inclusion
Standard care strategies	Strategies considered to be important in patients who receive ventilation, including: use of antibiotic prophylaxis	Daily up to 14 days from inclusion

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Marcus J. Schultz, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

General Publications

• 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.

Helpful Links

• LAMiNAR Website
• PROVE NETWORK Website

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: December 7, 2014
• First Posted (Estimate): December 9, 2014

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Burn patients
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: LAMiNAR