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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

1.7 years

First QC Date

December 4, 2014

Last Update Submit

June 26, 2017

Conditions

Burns - MultipleMechanical Ventilation

Keywords

Mechanical VentilationBurn patients

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (19)

  • Number of ventilator-free days and alive at day 28

    From day 1 to day 28

  • Other Ventilation Parameters

    Up to 14 days during mechanical ventilation

  • Other Ventilation Parameters

    Up to 14 days during mechanical ventilation

  • Other Ventilation Parameters

    Up to 14 days during mechanical ventilation

  • Other Ventilation Parameters

    Up to 14 days during mechanical ventilation

  • +14 more secondary outcomes

Other Outcomes (5)

  • Standard care strategies

    Daily up to 14 days from inclusion

  • Standard care strategies

    Daily up to 14 days from inclusion

  • Standard care strategies

    Daily up to 14 days from inclusion

  • +2 more other outcomes

Interventions

No interventionOTHER

not applicable, observational study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Burns
  • Admission to a participating burn ICU Need for invasive ventilation
  • Informed consent (only if applicable in the country where data are collected)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, South Holland, 1105AZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 34926707DERIVED

Related Links

Study Officials

  • Marcus J. Schultz, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 9, 2014

Study Start

September 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

NL(1)