Burns - MultipleLAMiNARNCT02312869
Local Assessment of Management of Burn Patients
An observational study of Burns - Multiple and Mechanical Ventilation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns - Multiple, Mechanical Ventilation
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2015to 1 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive intubated and ventilated burn patients admitted to participating ICUs during a period of 3 months
Who may be able to join
- Burns
- Admission to a participating burn ICU Need for invasive ventilation
- Informed consent (only if applicable in the country where data are collected)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, South Holland, 1105AZ
About this study
Official title: 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.
Read the 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
- Being tested
- No intervention
- Keywords
- Mechanical Ventilation, Burn patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
not applicable, observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation parameters
Tidal volume size; milliliters per kilogram of predicted body weight
Measured: Up to 14 days during mechanical ventilation
Ventilation parameters
Level of positive end-expiratory pressure (PEEP); cm H2O
Measured: Up to 14 days during mechanical ventilation
Ventilation parameters
Fraction of oxygen in inspired air (FiO2), %
Measured: Up to 14 days during mechanical ventilation
Ventilation parameters
Mode of ventilation; assist-control or spontaneous modes of ventilation
Measured: Up to 14 days during mechanical ventilation
Secondary outcomes (19)
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'
Measured: From day 1 to day 28
Other Ventilation Parameters
Peak and plateau pressures or maximum airway pressure
Measured: Up to 14 days during mechanical ventilation
Other Ventilation Parameters
Respiratory rate
Measured: Up to 14 days during mechanical ventilation
Other Ventilation Parameters
Inspiration to expiration ratio
Measured: Up to 14 days during mechanical ventilation
Other Ventilation Parameters
Peripheral oxygen saturation
Measured: Up to 14 days during mechanical ventilation
Other Ventilation Parameters
Arterial blood gas parameters
Measured: Up to 14 days during mechanical ventilation
Length of Stay in ICU on Day 90
Time between admission and discharge or death
Measured: Until day 90
Length of Stay in Hospital on Day 90
Time between admission and discharge or death
Measured: Until day 90
All-cause ICU Mortality
Any death during ICU stay
Measured: Until day 90
All-cause Hospital Mortality
Any death during hospital stay
Measured: Until day 90
Need for Tracheostomy
Need for tracheostomy, first tracheostomy will be assessed up to 14 days from inclusion
Measured: 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.
Measured: Up to 14 days during mechanical ventilation
Daily Sequential Organ Failure Assessment (SOFA)-scores
six-organ dysfunction/failure score measuring multiple organ failure daily
Measured: Daily up to 14 days from inclusion
Complications
Complications will include: Skin and soft tissue infections
Measured: Daily up to 14 days from inclusion
Complications
Complications will include: (Ventilator associated) Pneumonia
Measured: Daily up to 14 days from inclusion
Complications
Complications will include: Sepsis
Measured: Daily up to 14 days from inclusion
Complications
Complications will include: Acute respiratory distress syndrome according to Berlin criteria
Measured: Daily up to 14 days from inclusion
Complications
Complications will include: Acute renal failure
Measured: Daily up to 14 days from inclusion
Complications
Complications will include: Abdominal compartment syndrome
Measured: Daily up to 14 days from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startSep 2015
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burns - MultipleStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Marcus J. Schultz, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312869
- Sponsor's protocol ID
- LAMiNAR
- Acronym
- LAMiNAR
- Status last verified
- Jun 2017
- First submitted
- 4 Dec 2014
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 34926707
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Assessment of Management of Burn Patients (LAMiNAR) - a Prospective Observational International Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT02312869
- Acronym / sponsor ID
- LAMiNAR / LAMiNAR
- Conditions
- Burns - Multiple, Mechanical Ventilation
- Keywords
- Mechanical Ventilation, Burn patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Sep 2015
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive intubated and ventilated burn patients admitted to participating ICUs during a period of 3 months
Key inclusion criteria (3 listed)
- Burns
- Admission to a participating burn ICU Need for invasive ventilation
- Informed consent (only if applicable in the country where data are collected)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionnot applicable, observational study | Other | – |
Primary outcome
Ventilation parameters
Time frame: Up to 14 days during mechanical ventilation
Tidal volume size; milliliters per kilogram of predicted body weight
Ventilation parameters
Time frame: Up to 14 days during mechanical ventilation
Level of positive end-expiratory pressure (PEEP); cm H2O
Ventilation parameters
Time frame: Up to 14 days during mechanical ventilation
Fraction of oxygen in inspired air (FiO2), %
Ventilation parameters
Time frame: Up to 14 days during mechanical ventilation
Mode of ventilation; assist-control or spontaneous modes of ventilation
19 secondary outcomes
Number of ventilator-free days and alive at day 28
Time frame: From day 1 to day 28
Other Ventilation Parameters
Time frame: Up to 14 days during mechanical ventilation
Other Ventilation Parameters
Time frame: Up to 14 days during mechanical ventilation
Other Ventilation Parameters
Time frame: Up to 14 days during mechanical ventilation
Other Ventilation Parameters
Time frame: Up to 14 days during mechanical ventilation
Other Ventilation Parameters
Time frame: Up to 14 days during mechanical ventilation
Length of Stay in ICU on Day 90
Time frame: Until day 90
Length of Stay in Hospital on Day 90
Time frame: Until day 90
All-cause ICU Mortality
Time frame: Until day 90
All-cause Hospital Mortality
Time frame: Until day 90
Need for Tracheostomy
Time frame: daily up to 14 days from inclusion
Daily Lung Injury Scores
Time frame: Up to 14 days during mechanical ventilation
Daily Sequential Organ Failure Assessment (SOFA)-scores
Time frame: Daily up to 14 days from inclusion
Complications
Time frame: Daily up to 14 days from inclusion
Complications
Time frame: Daily up to 14 days from inclusion
Complications
Time frame: Daily up to 14 days from inclusion
Complications
Time frame: Daily up to 14 days from inclusion
Complications
Time frame: Daily up to 14 days from inclusion
Complications
Time frame: Daily up to 14 days from inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Derived from this study: PubMed 34926707Schultz 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.
- LAMiNAR WebsiteLink provided by the sponsor.
- PROVE NETWORK WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus J. Schultz, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns - Multiple and Mechanical Ventilation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation parameters (time frame: Up to 14 days during mechanical ventilation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02312869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.