Local Assessment of Management of Burn Patients

Mechanical Ventilation Clinical Trial

— LAMiNAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312869
• Other study ID #: LAMiNAR
• Status: Completed
• Phase: N/A
• First received: December 4, 2014
• Last updated: June 26, 2017
• Start date: September 2015
• Est. completion date: May 1, 2017

Study information

• Verified date: June 2017
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Burns
• Burns - Multiple
• Mechanical Ventilation

Intervention

Other:
• No intervention
not applicable, observational study

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Ventilation parameters	Tidal volume size; milliliters per kilogram of predicted body weight	Up to 14 days during mechanical ventilation
Primary	Ventilation parameters	Level of positive end-expiratory pressure (PEEP); cm H2O	Up to 14 days during mechanical ventilation
Primary	Ventilation parameters	Fraction of oxygen in inspired air (FiO2), %	Up to 14 days during mechanical ventilation
Primary	Ventilation parameters	Mode of ventilation; assist-control or spontaneous modes of ventilation	Up to 14 days during mechanical ventilation
Secondary	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
Secondary	Other Ventilation Parameters	Peak and plateau pressures or maximum airway pressure	Up to 14 days during mechanical ventilation
Secondary	Other Ventilation Parameters	Respiratory rate	Up to 14 days during mechanical ventilation
Secondary	Other Ventilation Parameters	Inspiration to expiration ratio	Up to 14 days during mechanical ventilation
Secondary	Other Ventilation Parameters	Peripheral oxygen saturation	Up to 14 days during mechanical ventilation
Secondary	Other Ventilation Parameters	Arterial blood gas parameters	Up to 14 days during mechanical ventilation
Secondary	Length of Stay in ICU on Day 90	Time between admission and discharge or death	Until day 90
Secondary	Length of Stay in Hospital on Day 90	Time between admission and discharge or death	Until day 90
Secondary	All-cause ICU Mortality	Any death during ICU stay	Until day 90
Secondary	All-cause Hospital Mortality	Any death during hospital stay	Until day 90
Secondary	Need for Tracheostomy	Need for tracheostomy, first tracheostomy will be assessed up to 14 days from inclusion	daily up to 14 days from inclusion
Secondary	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
Secondary	Daily Sequential Organ Failure Assessment (SOFA)-scores	six-organ dysfunction/failure score measuring multiple organ failure daily	Daily up to 14 days from inclusion
Secondary	Complications	Complications will include: Skin and soft tissue infections	Daily up to 14 days from inclusion
Secondary	Complications	Complications will include: (Ventilator associated) Pneumonia	Daily up to 14 days from inclusion
Secondary	Complications	Complications will include: Sepsis	Daily up to 14 days from inclusion
Secondary	Complications	Complications will include: Acute respiratory distress syndrome according to Berlin criteria	Daily up to 14 days from inclusion
Secondary	Complications	Complications will include: Acute renal failure	Daily up to 14 days from inclusion
Secondary	Complications	Complications will include: Abdominal compartment syndrome	Daily up to 14 days from inclusion

External Links

•   LAMiNAR Website
•   PROVE NETWORK Website