A prospective, controlled trial of a protocol-based strategy to discontinue mechanical ventilation. A randomised, controlled trial of conventional versus automated weaning from mechanical ventilation using SmartCare/PS. A multicenter randomized trial of computer-driven protocolized weaning from mechanical ventilation. Optimization of mechanical ventilation support following cardiac surgery. Automatic control of pressure support for ventilator weaning in surgical intensive care patients. Automatic versus manual pressure support reduction in the weaning of post-operative patients: a randomised controlled trial. Effects of patient-triggered automatic switching between mandatory and supported ventilation in the postoperative weaning period. A randomized, controlled trial of protocol-directed versus physician-directed weaning from mechanical ventilation. Automatic "respirator/weaning" with adaptive support ventilation: the effect on duration of endotracheal intubation and patient management.
Weaning protocols can improve outcomes, but their efficacy may vary with patient and staff characteristics. In this prospective, controlled trial, we compared protocol-based weaning to usual, physician-directed weaning in a closed medical intensive care unit (ICU) with high physician staffing levels and structured, system-based rounds. Adult patients requiring mechanical ventilation for more than 24 hours were assigned to usual care (UC) or protocol weaning based on their hospital identification number. Patients assigned to UC (n=145) were managed at their physicians' discretion. Patients assigned to protocol (n=154) underwent daily screening and a spontaneous breathing trial by respiratory and nursing staff without physician intervention. There were no significant baseline differences in patient characteristics between groups. The proportion of patients (protocol vs. UC) who successfully discontinued mechanical ventilation (74.7% vs. 75.2%, p=0.92), duration of mechanical ventilation (median [interquartile range]: 60.4 hours [28.6-167.0 hours] vs. 68.0 hours [27.1-169.3 hours], p=0.61), ICU (25.3% vs. 28.3%) and hospital mortality (36.4% vs. 33.1%), ICU length of stay (115 vs. 146 hours), and rates of reinstituting mechanical ventilation (10.3% vs. 9.0%) was similar. We conclude that protocol-directed weaning may be unnecessary in a closed ICU with generous physician staffing and structured rounds. Preliminary assessment of an automated weaning system (SmartCare/PS) compared to usual management of weaning from mechanical ventilation performed in the absence of formal protocols.
                A randomised, controlled pilot study in one Australian intensive care unit.
                A total of 102 patients were equally divided between SmartCare/PS and Control.
                The automated system titrated pressure support, conducted a spontaneous breathing trial and provided notification of success ("separation potential").
                The median time from the first identified point of suitability for weaning commencement to the state of "separation potential" using SmartCare/PS was 20 h (interquartile range, IQR, 2-40) compared to 8 h (IQR 2-43) with Control (log-rank P = 0.3). The median time to successful extubation was 43 h (IQR 6-169) using SmartCare/PS and 40 (14-87) with Control (log-rank P = 0.6). Unadjusted, the estimated probability of reaching "separation potential" was 21% lower (95% CI, 48% lower to 20% greater) with SmartCare/PS compared to Control. Adjusted for other covariates (age, gender, APACHE II, SOFAmax, neuromuscular blockade, corticosteroids, coma and elevated blood glucose), these estimates were 31% lower (95% CI, 56% lower to 9% greater) with SmartCare/PS. The study groups showed comparable rates of reintubation, non-invasive ventilation post-extubation, tracheostomy, sedation, neuromuscular blockade and use of corticosteroids.
                Substantial reductions in weaning duration previously demonstrated were not confirmed when the SmartCare/PS system was compared to weaning managed by experienced critical care specialty nurses, using a 1:1 nurse-to-patient ratio. The effect of SmartCare/PS may be influenced by the local clinical organisational context.
                28. Mechanical ventilation: weaning. Duration of weaning from mechanical ventilation may be reduced by the use of a systematic approach. We assessed whether a closed-loop knowledge-based algorithm introduced in a ventilator to act as a computer-driven weaning protocol can improve patient outcomes as compared with usual care.
                We conducted a multicenter randomized controlled study with concealed allocation to compare usual care for weaning with computer-driven weaning. The computerized protocol included an automatic gradual reduction in pressure support, automatic performance of spontaneous breathing trials (SBT), and generation of an incentive message when an SBT was successfully passed. One hundred forty-four patients were enrolled before weaning initiation. They were randomly allocated to computer-driven weaning or to physician-controlled weaning according to local guidelines. Weaning duration until successful extubation and total duration of ventilation were the primary endpoints.
                Weaning duration was reduced in the computer-driven group from a median of 5 to 3 d (p=0.01) and total duration of mechanical ventilation from 12 to 7.5 d (p=0.003). Reintubation rate did not differ (23 vs. 16%, p=0.40). Computer-driven weaning also decreased median intensive care unit (ICU) stay duration from 15.5 to 12 d (p=0.02) and caused no adverse events. The amount of sedation did not differ between groups. In the usual care group, compliance to recommended modes and to SBT was estimated, respectively, at 96 and 51%.
                The specific computer-driven system used in this study can reduce mechanical ventilation duration and ICU length of stay, as compared with a physician-controlled weaning process. Mechanical ventilation (MV) is essential in the management of patients that underwent cardiac surgery and cardiopulmonary bypass. It has been demonstrated that MV dependence is directly related to morbidity incidence and ICU length of stay, with a strong impact on economic cost. Therefore identification of measures that can reduce MV interval, may reduce the incidence of respiratory complications and length of hospitalization. The aim of this study was to identify weaning indexes and adopt a weaning algorithm in order to optimize ventilatory support after cardiac surgery.
                Forty-nine patients with low and medium Higgins risk score, who underwent, between February and November 1999, elective surgery at our Institution, were enrolled in this study. All patients were randomized into 2 groups: Group I (weaning group - 24 patients), extubated with the aid of a weaning protocol, and Group II (control group - 25 patients), extubated with conservative weaning, dependent on the physician's subjective clinical judgment. All patients were successfully weaned from mechanical support.
                Intubation time was significantly lower in Group I than Group II and "Fast Track Recovery" group (p=0.05). ICU length of stay was also significantly lower in Group I (p=0.03). Analysis of weaning indexes did not show cut-off points predictive of successful weaning, except for PaO2/FiO2 ratio, which was higher in Group I (p=0.02).
                These results confirm that the use of a weaning algorithm enables the MV interval and hospital length of stay to be shortened, suggesting that it should be used in the management following cardiac surgery. Despite its ability to reduce overall ventilation time, protocol-guided weaning from mechanical ventilation is not routinely used in daily clinical practice. Clinical implementation of weaning protocols could be facilitated by integration of knowledge-based, closed-loop controlled protocols into respirators.
                To determine whether automated weaning decreases overall ventilation time compared with weaning based on a standardized written protocol in an unselected surgical patient population.
                In this prospective controlled trial patients ventilated for longer than 9 hours were randomly allocated to receive either weaning with automatic control of pressure support ventilation (automated-weaning group) or weaning based on a standardized written protocol (control group) using the same ventilation mode. The primary end point of the study was overall ventilation time.
                Overall ventilation time (median [25th and 75th percentile]) did not significantly differ between the automated-weaning (31 [19-101] h; n = 150) and control groups (39 [20-118] h; n = 150; P = 0.178). Patients who underwent cardiac surgery (n = 132) exhibited significantly shorter overall ventilation times in the automated-weaning (24 [18-57] h) than in the control group (35 [20-93] h; P = 0.035). The automated-weaning group exhibited shorter ventilation times until the first spontaneous breathing trial (1 [0-15] vs. 9 [1-51] h; P = 0.001) and a trend toward fewer tracheostomies (17 vs. 28; P = 0.075).
                Overall ventilation times did not significantly differ between weaning using automatic control of pressure support ventilation and weaning based on a standardized written protocol. Patients after cardiac surgery may benefit from automated weaning. Implementation of additional control variables besides the level of pressure support may further improve automated-weaning systems. Clinical trial registered with www.clinicaltrials.gov (NCT 00445289). Reduction of automatic pressure support based on a target respiratory frequency or mandatory rate ventilation (MRV) is available in the Taema-Horus ventilator for the weaning process in the intensive care unit (ICU) setting. We hypothesised that MRV is as effective as manual weaning in post-operative ICU patients.
                There were 106 patients selected in the post-operative period in a prospective, randomised, controlled protocol. When the patients arrived at the ICU after surgery, they were randomly assigned to either: traditional weaning, consisting of the manual reduction of pressure support every 30 minutes, keeping the respiratory rate/tidal volume (RR/TV) below 80 L until 5 to 7 cmH2O of pressure support ventilation (PSV); or automatic weaning, referring to MRV set with a respiratory frequency target of 15 breaths per minute (the ventilator automatically decreased the PSV level by 1 cmH2O every four respiratory cycles, if the patient's RR was less than 15 per minute). The primary endpoint of the study was the duration of the weaning process. Secondary endpoints were levels of pressure support, RR, TV (mL), RR/TV, positive end expiratory pressure levels, FiO2 and SpO2 required during the weaning process, the need for reintubation and the need for non-invasive ventilation in the 48 hours after extubation.
                In the intention to treat analysis there were no statistically significant differences between the 53 patients selected for each group regarding gender (p = 0.541), age (p = 0.585) and type of surgery (p = 0.172). Nineteen patients presented complications during the trial (4 in the PSV manual group and 15 in the MRV automatic group, p < 0.05). Nine patients in the automatic group did not adapt to the MRV mode. The mean +/- sd (standard deviation) duration of the weaning process was 221 +/- 192 for the manual group, and 271 +/- 369 minutes for the automatic group (p = 0.375). PSV levels were significantly higher in MRV compared with that of the PSV manual reduction (p < 0.05). Reintubation was not required in either group. Non-invasive ventilation was necessary for two patients, in the manual group after cardiac surgery (p = 0.51).
                The duration of the automatic reduction of pressure support was similar to the manual one in the post-operative period in the ICU, but presented more complications, especially no adaptation to the MRV algorithm.
                Trial registration number: ISRCTN37456640. To compare two ventilator settings in the postoperative weaning period. Patient-triggered automatic switching between controlled ventilation and supported spontaneous breathing (Automode, AM) was compared to synchronised intermittent mandatory ventilation (SIMV) with stepwise manual adjustment of mandatory frequency according to the breathing activity.
                Prospective clinical investigation.
                Eighteen-bed intensive care unit in a university hospital.
                Forty postoperative patients with healthy lungs who had undergone brain tumour surgery.
                Randomisation either to the AM or SIMV weaning procedure after entering the ICU.
                Total weaning time and number of manipulations on the ventilator were observed. Cardiocirculatory and respiratory parameters were measured consecutively at five points during the weaning period. No significant differences were seen for cardiocirculatory parameters, airway pressures and oxygenation between the two groups. There was a trend to shorter weaning times with AM (136 +/- 46 min vs 169 +/- 68 min, n.s.), the average number of manipulations on the ventilator was lower (0.55 +/- 0.69 vs 5.05 +/- 1.19,p < 0.001) and arterial partial pressure of carbon dioxide (PaCO2) levels showed fewer variations in the late phase of the weaning period (39.5 +/- 3.1 vs 38.3 +/- 7.2, p < 0.001 for differences in variance).
                Automatic, patient-triggered switching between controlled and supported mode of ventilation can be used for postoperative weaning of neurosurgical patients with healthy lungs. Compared to a SIMV weaning procedure, fewer manipulations on the ventilator are necessary and individual adaptation of ventilation seems to be more accurate. To compare a practice of protocol-directed weaning from mechanical ventilation implemented by nurses and respiratory therapists with traditional physician-directed weaning.
                Randomized, controlled trial.
                Medical and surgical intensive care units in two university-affiliated teaching hospitals.
                Patients requiring mechanical ventilation (n = 357).
                Patients were randomly assigned to receive either protocol-directed (n = 179) or physician-directed (n = 178) weaning from mechanical ventilation.
                The primary outcome measure was the duration of mechanical ventilation from tracheal intubation until discontinuation of mechanical ventilation. Other outcome measures included need for reintubation, length of hospital stay, hospital mortality rate, and hospital costs. The median duration of mechanical ventilation was 35 hrs for the protocol-directed group (first quartile 15 hrs; third quartile 114 hrs) compared with 44 hrs for the physician-directed group (first quartile 21 hrs; third quartile 209 hrs). Kaplan-Meier analysis demonstrated that patients randomized to protocol-directed weaning had significantly shorter durations of mechanical ventilation compared with patients randomized to physician-directed weaning (chi 2 = 3.62, p = .057, log-rank test; chi 2 = 5.12, p = .024, Wilcoxon test). Cox proportional-hazards regression analysis, adjusting for other covariates, showed that the rate of successful weaning was significantly greater for patients receiving protocol-directed weaning compared with patients receiving physician-directed weaning (risk ratio 1.31; 95% confidence interval 1.15 to 1.50; p = .039). The hospital mortality rates for the two treatment groups were similar (protocol-directed 22.3% vs. physician-directed 23.6%; p = .779). Hospital cost savings for patients in the protocol-directed group were $42,960 compared with hospital costs for patients in the physician-directed group.
                Protocol-guided weaning of mechanical ventilation, as performed by nurses and respiratory therapists, is safe and led to extubation more rapidly than physician-directed weaning. Adaptive support ventilation (ASV) provides an automatic adaptation of the ventilator settings to patient's passive and active respiratory mechanics. In a randomized controlled study, we evaluated automatic respiratory weaning in ASV for early tracheal extubation after cardiac surgery. Eligible patients were assigned to either an ASV protocol or a standard one consisting of synchronized intermittent ventilation followed by pressure support. Eighteen patients completed the ASV protocol, and 16 completed the standard one. There were no differences between groups in perioperative characteristics, lengths of tracheal intubation and intensive care unit stay, and ventilatory variables, except less peak inspiratory pressure during the initial phase in ASV (17.5 +/- 0.8 versus 22.2 +/- 0.8 cm H(2)O; P < 0.01). ASV patients required fewer ventilatory settings manipulations (2.4 +/- 0.7 versus 4.0 +/- 0.8 manipulations per patient; P < 0.05) and endured less high-inspiratory pressure alarms (0.7 +/- 2.4 versus 2.9 +/- 3.0; P < 0.05). These results suggest that in this specific population of patients, automation of postoperative ventilation with ASV resulted in an outcome similar to the control group. The internal logic of the new device resulted in less manipulation of the setting and alarms that could simplify respiratory management.
                Adaptive support ventilation (ASV), a ventilatory mode providing automatic adjustment of the settings was compared with standard management for rapid tracheal extubation after cardiac surgery. The two approaches were equal in terms of outcome. In ASV, we observed fewer ventilator settings manipulations and a smaller amount of alarms, suggesting that this automatic mode may simplify postoperative respiratory management without delaying extubation.
Automated closed loop systems may result in reduced duration of weaning, ventilation, and ICU stay. Reductions are more likely to occur in mixed or medical ICU populations. Due to the lack of, or limited, evidence on automated systems other than Smartcare/PS™ and Adaptive Support Ventilation no conclusions can be drawn regarding their influence on these outcomes. Due to substantial heterogeneity in trials there is a need for an adequately powered, high quality, multi-centre randomized controlled trial in adults that excludes 'simple to wean' patients. There is a pressing need for further technological development and research in the paediatric population.