Local Assessment of Management of Burn Patients

NCT ID: NCT02312869

Last Updated: 2017-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-05-01

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.

Conditions

Burns - Multiple; Mechanical Ventilation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

No intervention

not applicable, observational study

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Marcus J. Schultz

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcus J. Schultz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Academic Medical Center

Amsterdam, South Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 34926707 (View on PubMed)

Related Links

https://sites.google.com/site/laminarstudy/

LAMiNAR Website

https://sites.google.com/site/proveneteu/provenet-studies

PROVE NETWORK Website

Other Identifiers

LAMiNAR

Identifier Type: -

Identifier Source: org_study_id