MUltiparametric Score for Ventilation Discontinuation in Intensive Care Patients: A Protocol for an Observational Study
Abstract
:1. Introduction
2. Experimental Design
2.1. Setting
2.2. Study Population
- Informed consent;
- Age > 18 yo;
- Duration of mechanical ventilation > 48 h via endotracheal tube (ETT) or tracheostomy cannula;
- Assisted mechanical ventilation for at least 12 h with FiO2 ≤ 0.5, PEEP ≤ 6 cmH2O and pressure support ≤ 8 cmH2O;
- Respiratory rate ≤ 25;
- PaO2/FiO2 ratio > 150;
- pH > 7.38;
- Hemodynamic stability;
- Hb > 7 g/dL;
- Normothermia.
- Patients who are unable to provide informed consent and do not have a legal representative available to provide consent.
- Patients with medical conditions that, according to the clinical judgment of the intensive care team, make the weaning process inappropriate or unsafe.
2.3. Bias
2.4. Sample Size
2.5. Statistical Analysis
3. Procedure
3.1. Variables
- LUS (Lung Ultrasound Score);
- Presence/absence of pleural effusion and extent;
- Airway Occlusion Pressure in the first 100 ms (P 0.1);
- Biventricular systolic function (EF for the left ventricle, TAPSE for the right ventricle);
- Left ventricular diastolic function (lateral e′, E/A, E/e′);
- Evaluation of possible impairment of airway protection;
- Neurological comorbidities.
- Rapid Shallow Breathing Index (RSBI);
- Diaphragmatic excursion (DE);
- Diaphragmatic thickening fraction (DTF);
- Intercostal muscle thickening fraction (IM-TF).
- Respiratory rate > 25/min or <5/min;
- Onset of a new arrhythmia;
- Heart rate > 110 bpm or <45 bpm;
- Systolic Blood Pressure > 160 mmHg or <90 mmHg;
- SpO2 < 90%;
- Activation of accessory respiratory muscles;
- Respiratory acidosis;
- Altered mental status.
- Outcome of the extubation process: success or failure.
- Time to successfully complete the weaning process: number of days.
- Length of stay in intensive care: number of days.
- Mortality in intensive care: proportion of patients.
- Need for reintubation within 48 h of extubation: proportion of patients.
3.2. Evaluation before SBT
3.2.1. Non-Ultrasound Measurements
- Neurological comorbidities (such as ICU-Acquired Weakness, stroke, encephalitis, meningitis, delirium, anxiety syndromes) and the presence of possible factors compromising airway protection (such as neurological deficits, swallowing deficits, ICU-AW) will be extrapolated from patient history.
- The value of the drop in airway pressure 100 milliseconds after the onset of inspiration during an end-expiratory occlusion of the airway (P 0.1) will be derived from the analysis performed by the ventilator.
3.2.2. Ultrasound Measurements
- LUS (Lung Ultrasound Score): The most used score in critical environments for the evaluation of lung parenchyma is certainly the Lung Ultrasound Score (LUS). This scoring system consists of giving a score of pulmonary parenchyma aeration in 12 regions (6 for each hemithorax); the global score is given by the sum of the values of each parenchymal region. In every region, four steps of progressive loss of lung aeration can be identified: score 0 (normal aeration with A lines or no more than two B lines), score 1 (moderate loss of aeration with at least three B lines or confluent B lines or subpleural consolidations involving less than 50% of the visualized pleura), score 2 (severe loss of aeration with confluent B lines or subpleural consolidations involving more than 50% of the pleura visualized) and score 3 (complete loss of aeration with hepatization of the lung parenchyma). As a result, the total LUS value ranges from 0 to 36 [20]. The 12 regions are delimited by anatomical landmarks, as established by consensus in a 2012 conference on point-of-care LUSs [21].
- Over the years, it has been shown that this score reliably evaluates the aeration of the lung parenchyma in critically ill patients [22,23,24,25]. This tool is therefore useful in evaluating lung parenchyma during the weaning process and in identifying patients at high risk of weaning failure. Soummer et al. demonstrated that the LUS predicts weaning failure with accuracy by identifying regional and global lung de-recruitment [26]. In the weaning setting, the LUS has proven accurate in predicting the occurrence of post-extubation respiratory distress: the score is higher in patients experiencing weaning failure and post-extubation distress. On the other hand, the LUS remains significantly below a cut-off value in patients who are successfully weaned. The cut-off identified in the literature to predict an 85% risk of post-extubation failure is >17; the safest value below which the risk of developing a weaning failure is negligible is <13; and a score between 13 and 17 has no predictive value [26];
- Presence/absence of pleural effusion and extent: The accumulation of pleural fluid causes atelectasis due to collapse of the parenchyma adjacent to the effusion, which generates hydrostatic pressure. This can be easily assessed with ultrasound. Large pleural effusions could cause total lobar or pulmonary atelectasis. Atelectasis of lung parenchyma prevents air from reaching the alveoli, thus resulting in less alveolar volume available for respiratory exchanges and the possible creation of a shunt with hypoxemia. Moreover, the lung elastic recoil no longer opposes the elastic return of the rib cage, determining an alteration of the conformation of the latter at the level of the effusion area. The outward movement of the rib cage causes an alteration in the length and tension of the intercostal muscle fibers with lower efficiency of their contraction. The diaphragm is decoupled from the visceral pleural surface, and therefore its contraction presents an attenuated effect on pulmonary insufflation. While the volume of the pleural effusion can be accurately estimated using US [27,28,29,30], it is not clear beyond which volume the drainage is indicated. In our study, the presence and entity of pleural effusion will be evaluated with a convex probe in the lateral and posterolateral thoracic region. The entity of the effusion will be assessed by measuring the maximum perpendicular distance between the parietal pleura and the lung parenchyma.
- Biventricular systolic function (EF for the left ventricle, TAPSE for the right ventricle): To evaluate left ventricular global systolic function, we will use the Ejection Fraction. The EF (%) will be obtained using Simpson’s biplanar method in the apical 4-chamber and apical 2-chamber views (EF = (Left Ventricular End Diastolic Volume − Left Ventricular End Systolic Volume)/Left Ventricular End Diastolic Volume).
- Right ventricular systolic function will be evaluated using Tricuspid Annular Plane Systolic Excursion (TAPSE) in apical 4-chamber view (US beam in M-Mode must be aligned on the lateral portion of the tricuspid annulus obtaining a measurement of its systolic excursion in millimeters).
- In the case of dysfunction of even just one of the two items, the systolic function will be considered abnormal.
- Left ventricular diastolic function (e′, E/A, E/e′): Evaluation of the diastolic function of the left ventricle requires the ability to use Pulsed Wave Doppler (PWD) as well as Tissue Doppler Imaging (TDI). The inflow profile of the mitral valve recorded via the PWD (E wave in the early diastolic phase and A wave in the late diastolic phase) depends on the diastolic function and the filling pressures of the left ventricle, while the TDI of the mitral annulus allows to separate the evaluation of left ventricular relaxation (e′ wave) and left ventricular filling pressure (E/e′ ratio). The use of echocardiography before the SBT could be useful in identifying patients at high risk of weaning failure. In a population of 117 patients, Callie et al. reported that 23 patients who failed the SBT had a lower left ventricle EF and a tendency to higher E/e′ ratios before the SBT [31]. Moschietto et al. reported no difference in a weaning failure group in terms of the LVEF but an increase in the E/e′ ratio [32]. Papanikolaou et al. demonstrated the impact of diastolic function in a group of 50 patients with a preserved LVEF: the worse the pre-SBT diastolic function the higher the percentage of patients with SBT failure [33]. In a meta-analysis by Sanfilippo et al. [34], it was found that diastolic dysfunction and high LV filling pressures were associated with higher percentages of weaning failure, while the role of the LVEF was less clear. In this study, the strongest association with weaning failure was found with high E/e′ values. During the weaning trial, the increased pool of blood returning to the LV may not be easily managed if LV compliance is reduced, creating an increase in post-capillary pulmonary pressures with the onset of pulmonary edema. E wave velocity and the E/A ratio are useful for grading LVDD, but not for its diagnosis. In accordance with the guidelines, in our study, the E and A values will be obtained from the peak velocity of the E-wave and the A-wave (cm/sec) using a PW Doppler in apical 4-chamber view, optimizing the alignment between sampling and blood flow through the color Doppler. The e′ value (lateral) will be obtained in apical projection with 4 cameras using PW-TDI (Pulsed Wave-Tissue Doppler function Imaging) in the lateral basal regions of the LV. From the obtained values, we can measure the E/e′ ratio. To identify diastolic dysfunction, e′ and the E/e′ ratio will be used according to the indications of the 2016 ASA/EACVI guidelines. To distinguish the degrees of diastolic dysfunction (Grade I or Impaired Relaxation, Grade II or Pseudonormalization, Grade III or Restrictive Pattern) the E/A ratio will be used according to indications of the ASA/EACVI guidelines of 2016 [35].
3.3. Evaluation during SBT
3.3.1. Non-Ultrasound Measurements
- Rapid Shallow Breathing Index (RSBI): In 1986, Tobin and colleagues, observing breathing patterns during weaning trials, quantified the phenomenon of rapid and shallow breathing with the relationship between the respiratory rate (RR) and tidal volume (TV) [13]. This relationship proved itself superior to all other predictive tests for weaning failure. In fact, currently, one of the most used predictive indices is certainly the Rapid Shallow Breathing Index (RSBI). This index is defined as the relationship between the RR and TV, parameters easily measurable through a spirometric test or simply by using the ventilator. An RSBI ≥ 105 breaths/minute/L indicates that the patient is likely to fail weaning, while a value < 105 is more likely an indicator of possible weaning success. The values of the RR and TV during the SBT will be derived directly from the ventilator monitor in our study.
3.3.2. Ultrasound Measurements
- Diaphragmatic excursion (DE): Ultrasonography allows one to visualize the two hemidiaphragms and their excursions during the respiratory cycle. To evaluate diaphragmatic performance, two different ultrasonographic parameters have been described [36]. The first parameter consists of measuring the diaphragmatic excursion (DE) during inspiration [37]. In the spontaneously breathing patient, diaphragmatic excursion is the result of a given diaphragmatic contraction for a given mechanical load (for example, the compliance of the respiratory system, including abdominal compliance). In patients subjected to positive pressure mechanical ventilation, the diaphragmatic excursion also depends on the extent of the pressure support, such as positive end-expiratory pressure (PEEP). PEEP, in fact, increases end-expiratory lung volume; the increase in this volume lowers the diaphragmatic dome, which may therefore have a reduced excursion [38]. A DE in an SBT < 11 mm increases the probability of trial failure [36]. To evaluate diaphragmatic excursions, a low-frequency convex transducer will be used: it will be positioned in the anterior subcostal region between the midclavicular line and the anterior axillary line. The probe in B-Mode will be positioned in the medial, cranial and dorsal directions in order to evaluate the posterior third of the right and left hemidiaphragms through the hepatic and splenic parenchyma, respectively. The M-Mode sampling line will then be positioned perpendicular to the diaphragm to obtain the maximum cranio-caudal excursion.
- Diaphragmatic thickening fraction (DTF): The second parameter to measure diaphragmatic performance instead describes muscle thickening during inspiration in the area where it is attached to the rib cage [39]. The measurement of diaphragmatic thickening can be used as an index of diaphragmatic efficiency as a pressure generator. The DTF will be measured using B-Mode ultrasonography at the level of the apposition area of the costophrenic sinus (where the diaphragm attaches to the rib cage), that is, anterior to the mid-axillary line near the VII-X ribs. The diaphragm will be identified as a trilaminar structure with two parallel echogenic lines (the diaphragmatic pleura and the peritoneal fascia), which enclose the hypoechoic diaphragmatic muscular structure. The diaphragmatic thickness will be obtained by measuring the distance of the pleural membrane from the peritoneal membrane with B-Mode images of the end of inspiration and the end of expiration. The percentage of the DTF (%) will be calculated with the following formula:100 × (end-inspiratory thickness − end-expiratory thickness)/end-expiratory thickness.A DTF during an SBT > 30–36% increases the probability of success [36].
- Intercostal muscle thickening fraction (IM-TF): The respiratory muscle pump is made up of 10 different skeletal muscles that are activated depending on the workload imposed [40]. When the diaphragmatic workload increases, these accessory muscles are recruited [41]. With higher levels of diaphragmatic inspiratory support, parasternal muscle activation decreases (in terms of thickening), while in patients with diaphragmatic dysfunction, the parasternal muscle thickening value increases [42]. The IM-TF is a good predictor of weaning outcome in mechanically ventilated critically ill patients. The thickness of intercostal muscles will be obtained using M-Mode ultrasonography. The high-frequency linear probe will be positioned transversely on the sagittal plane at the level of the II-III intercostal space, 3–5 cm laterally to the sternum. Starting in B-Mode, the intercostal muscles will be identified above the pleural line as a trilaminar biconcave structure stretched between two ribs. The muscle thickness will be measured between the hyperechoic layers of the muscle bands. The IM-TF (%) will be calculated with the following formula:100 × (end-inspiratory thickness − end-expiratory thickness)/end-expiratory thickness.
3.4. MUSVIP: MUltiparametric Score for Ventilation Discontinuation in Intensive Care Patients
- Patients who require interruption of their SBT;
- Patients who require reintubation in the 48 h following extubation;
- Patients who require reconnection to the ventilator within 48 h following disconnection from the ventilator (in the case of a tracheostomy tube in place);
- Patients who require non-invasive ventilation in the 48 h following extubation.
4. Expected Results
4.1. Primary Endpoint
4.2. Secondary Endpoints
- -
- Length of stay in intensive care: The study will assess whether the application of the predictive score can contribute to a reduction in the duration of ICU stays. By potentially identifying patients suitable for earlier weaning, the score might help in optimizing ICU resource utilization and enhancing patient throughput.
- -
- Mortality in intensive care: An essential aspect of the study will be to investigate the predictive score’s correlation with patient survival rates within the ICU. This evaluation will help determine if the timely identification of weaning candidates through the score can positively influence patient outcomes.
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- Need for reintubation within 48 h of extubation: A crucial measure of ventilation discontinuation success and patient safety is the avoidance of premature extubation, leading to reintubation. The study will explore the predictive score’s effectiveness in reducing the incidence of reintubation within 48 h of post-extubation, signifying a more accurate assessment of patient readiness for weaning.
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variable | Assessment | Partial MUSVIP |
---|---|---|
LUS | <13 | 12 |
13–17 | 6 | |
>17 | 0 | |
Pleural effusion | Absent or <2 cm | 12 |
2–4 cm | 6 | |
>4 cm | 0 | |
Systolic function | Normal | 12 |
Abnormal | 0 | |
Diastolic function | Normal | 12 |
Abnormal | 0 | |
Neurological comorbidities | Absent | 12 |
Present | 0 | |
Airway protection impairment | Absent | 12 |
Present | 0 | |
P 0.1 | ≥1 but <5 cmH2O | 12 |
<1 or ≥5 cmH2O | 0 |
Variable | Assessment | Partial MUSVIP |
---|---|---|
RSBI | <105 | 12 |
≥105 | 0 | |
DE | ≥11 mm | 12 |
<11 mm | 0 | |
DTF | ≥30% | 12 |
<30% | 0 | |
IM-TF | <10% | 12 |
≥10% | 0 |
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Cappellini, I.; Cardoni, A.; Campagnola, L.; Consales, G. MUltiparametric Score for Ventilation Discontinuation in Intensive Care Patients: A Protocol for an Observational Study. Methods Protoc. 2024, 7, 45. https://doi.org/10.3390/mps7030045
Cappellini I, Cardoni A, Campagnola L, Consales G. MUltiparametric Score for Ventilation Discontinuation in Intensive Care Patients: A Protocol for an Observational Study. Methods and Protocols. 2024; 7(3):45. https://doi.org/10.3390/mps7030045
Chicago/Turabian StyleCappellini, Iacopo, Andrea Cardoni, Lorenzo Campagnola, and Guglielmo Consales. 2024. "MUltiparametric Score for Ventilation Discontinuation in Intensive Care Patients: A Protocol for an Observational Study" Methods and Protocols 7, no. 3: 45. https://doi.org/10.3390/mps7030045