None listed
Conditions
Brief summary
Title Microcirculatory DySfunction and Skin Failure in Critically Ill patients: An exploratory study. (SoFIa Study) Aim To explore skin microvascular and macrovascular changes in critically ill patients. Study Design Quantitative, prospective, observational, exploratory design. Planned Sample Size 30 ICU patients meeting the selection criteria. Selection Criteria Inclusion Criteria • Intubated and mechanically ventilated. • 18 years old and over. • Expected length of ICU stay greater than 6 days. • SEM scanner score greater than or equal to 0.5 Exclusion Criteria • Pregnant Women • Imminent Death • Physiological condition prohibiting side positioning e.g. spinal injuries. • Skin conditions at perfusion measurement sites e.g. burns • Community acquired skin breakdown • Droplet precautions Outcome Measures Primary outcome measure Changes in perfusion at a cellular, microvascular and macrovascular levels measured by: • High levels of Syndecan-1 and soluble thrombomodulin in blood analysis, indicative widespread endothelial glycocalyx shedding and endothelial cell compromise. • Global microcirculatory blood flow changes via Incidental Dark Field imaging. • Local cutaneous blood flow changes at the sacrum and heels via Laser Speckle Contrast Imaging. • Macrovascular changes though the assessment of bedside haemodynamic measures. Statistical Analysis Plan Descriptive data will be analysed using frequencies, means as percentages as appropriate for continuous and categorical variables. Relationships between variables will be examined using a mixed effects model. Kaplan-Meier survival analysis will be used to compare time to new skin breakdown events. Duration of the study Commencement date – 21 August 2019; Completion date – 07 November 2019.
Interventions
Patient suitability will be confirmed within 18 hours of patient admission, with the registered nurse (RN) assigned to the patient, Clinical Nurse Consultant (CNC), the team leader (usually the CNC), Clinical Co-ordinator (CC) and medical staff member allocated to the patient. A suitable time for data collection will be co-ordinated with relevant staff members of the ICU department. The research nurse will then discuss the Patient Information and Consent (PICF) form with the person responsible at the bedside (if available) and include the patient, regardless of the patient’s conscious state, gaining consent from the person responsible for the patient. When data collecting, the research nurse will talk to the patient throughout the study procedures, regardless of conscious state (this is standard professional practice). When the patient is scheduled for repositioning the research nurse will set up the imaging equipment at the patient bedside. Participants will be studied in bed. Incidental Dark Field (IDF) imaging will be conducted prior to repositioning, while the patient is supine. The research nurse will place the IDF probe sublingually in 3 different locations under the tongue, as per the diagram within the case report form (CRF), holding the probe in each position for 30 seconds. The patient will then be assisted by the nursing and patient support officer onto their side to facilitate Laser Speckle Contrast Imaging (LSCI). This will be carried out discreetly and patient privacy and dignity will be maintained at all times. The research nurse will have the LSCI set up at the patient bedside prior to patient repositioning so once the patient is comfortable on their side the recording will take place. Once the patient is lying in position and the LSCI recording has started, the patient will remain in the position for 2-5mins. Finally, a 30 second sub epidermal moisture (SEM) scan will occur once LSCI is complete. Following study measure completion the bedside nurse and patient support officer will complete their reposition tasks. Blood sampling for the analysis of Syndecan-1 (SDC-1) and soluble thrombomodulin (sTM) will utilise two ml of plasma, which would otherwise be discarded, from all blood samples collected during the course of the patients ICU hospital admission, up until intensive care discharge. These samples will be aliquoted into four Eppendorf tubes and frozen at -80 C by Pathology Queensland laboratory staff. Laboratory staff will be notified which blood sampled will be collected via a phone call and pathology slip. The SDC-1 and sTM analysis will be conducted by Queensland pathology. Each sample will be measured in duplicate from the defrosted samples using a commercially available enzyme-linked immunosorbent assay (ELISA) kit once study recruit is complete. Any unused plasma will be discarded after five years of storage. Due to plasma samples being batch-processed outside of a clinically relevant timeframe, and clinicians not being advised of the results, there is no risk that patient care will be altered by the results of this testing. All observation and blood data collected will be obtained from Metavision, accessed by QLD health employed research staff only. Screening visit/Day of Enrolment The following processes will occur during the screening visit: • Signed informed consent form (document attempts to obtain consent) • Record participant demographics • Data collection On subsequent data collection days the following processes will occur: Day 1 • Signed informed consent form (document attempts to obtain consent) • Data collection • Incidental Dark Field imaging/ Laser Speckle Contrast Imaging • Adverse events notification Day 2 • Signed informed consent form (document attempts to obtain consent) • Data collection • Adverse events notification Day 3 • Signed informed consent form (document attempts to obtain consent) • Data collection • Incidental Dark Field imaging/ Laser Speckle Contrast Imaging • Adverse events notification Day 4 • Signed informed consent form (document attempts to obtain consent) • Data collection • Adverse events notification Day 5 • Signed informed consent form (document attempts to obtain consent) • Data collection • Incidental Dark Field imaging/ Laser Speckle Contrast Imaging • Adverse events notification Day 6 • Signed informed consent form (document attempts to obtain consent) • Data collection • Adverse events notification When participants’ admission to ICU is greater than 6 days, the study visits and procedures will be repeated once a week up to three weeks.
Sponsors
Eligibility
Inclusion criteria
• Intubated and mechanically ventilated. • 18 years old and over. • Expected length of ICU stay greater than 6 days. (length of stay 6 days and greater and known to increase the risk of skin breakdown in ICU patient) • SEM scanner score greater than or equal to 0.5
Exclusion criteria
Pregnant Women (Pregnant women have extremely high levels of SDC-1 for unknown reasons related to pregnancy that do not appear to be due to widespread EG shedding in the mother) • Imminent Death • Physiological condition prohibiting side positioning e.g. spinal injuries. • Skin conditions at perfusion measurement sites e.g. burns • Community acquired skin breakdown • Droplet precautions