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ORIGINAL ARTICLE
ABSTRACT
Background and objective: Low tidal volume ventilation has been shown to improve survival in acute respiratory distress syndrome (ARDS). Adaptive support
ventilation (ASV), a closed-loop ventilatory mode, can
minimize the work of breathing, and thus potentially
improve the outcomes in ARDS. The aim of this pilot,
randomized clinical trial was to compare the outcomes
of ASV versus volume-cycled ventilation (VCV) in
ARDS.
Methods: Patients with ARDS were randomly allocated to either ASV or VCV. The primary outcomes were
duration of mechanical ventilation, new-onset organ
dysfunction and hospital length of stay. The secondary
outcomes were ease of use of the ventilator mode
(assessed using the visual analogue scale (VAS)),
number of daily arterial blood gas analyses, daily
requirements of sedative and neuromuscular blockers,
and mortality.
Results: Forty-eight patients (28 males, 20 females)
with ARDS were randomized to receive either ASV
(n = 23) or VCV (n = 25) during the study period. The
baseline characteristics were almost similar in the two
groups. The duration of mechanical ventilation, delta
sequential organ failure assessment scores, intensive
care unit and hospital stay were comparable in the two
groups. The mortality (VCV-36% vs ASV-34.7%), ease of
use of mechanical ventilation, daily midazolam and
vecuronium doses, and the number of arterial blood
gas analyses performed were also similar in the two
groups.
Conclusions: There was no significant difference in
the outcomes of patients with ARDS ventilated with
either VCV or ASV in this study.
Key words: acute lung injury, acute respiratory distress syndrome, adaptive support ventilation, mechanical ventilation.
SUMMARY AT A GLANCE
Adaptive support ventilation (ASV), a closed-loop
ventilatory mode, can improve outcomes in ARDS
by minimizing the work of breathing. This study
analyzed the outcomes of ASV versus low tidal
volume ventilation in ARDS, and found no significant differences in the outcomes between the two
patient groups.
INTRODUCTION
Acute respiratory distress syndrome (ARDS) is a
disease characterized by acute inflammation and
increased permeability of pulmonary parenchyma
caused by varying aetiologies, in the absence of left
atrial hypertension.1 Since its initial description,2
ARDS has been associated with significant mortality.3,4 There is no specific pharmacological treatment
of ARDS. As ventilator-associated lung injury is an
important cause of poor clinical outcomes in ARDS,
ventilatory strategies are aimed at reducing the incidence and severity of ventilator-associated lung
injury. Newer ventilatory modes utilize algorithms
that perform breath-to-breath calculation of respiratory mechanics, thereby ensuring adequate minute
ventilation with least possible airway pressures,5
thereby decreasing the risk of ventilator-associated
lung injury.
Adaptive support ventilation (ASV) is a closedloop mode introduced in 1994 by Laubscher and
coworkers that automatically switches from pressure control ventilation to pressure-control synchronized intermittent mandatory ventilation or pressure
support ventilation, depending on the patients status.6,7 ASV works as per the Otis equation, thereby
Respirology (2013) 18, 11081115
doi: 10.1111/resp.12126
ASV in ARDS
METHODS
This was a prospective randomized clinical trial conducted between 1 July 2009 and 30 June 2011 in the
respiratory intensive care unit of our institute. The
respiratory intensive care unit is an eight-bedded,
closed intensive care unit (ICU) with five on-call consultants, five pulmonary fellows posted during a 24-h
shift and a nurse-to-patient ratio of 1:2.5. The study
was approved by the ethics review committee
(PGIMER, Chandigarh), and informed consent was
obtained from all patients (or next of kin). The
trial is registered with http://www.clinicaltrials.gov
(NCT01165528).
Patient selection
Patients with ARDS requiring invasive mechanical
ventilation were eligible for inclusion in the study if
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Respirology 2013 Asian Pacific Society of Respirology
1109
they met all the following:1 (i) acute onset dyspnoea
(<7 days); (ii) PaO2/FIO2 <200 mm Hg; (iii) bilateral
opacities on chest radiograph; and (iv) no clinical
evidence of left atrial hypertension. Patients were
excluded from the study if they demonstrated any of
the following: failure to provide informed consent,
age <12 years, pregnancy, chronic lung disease
and contraindications to permissive hypercapnea.
Patients meeting the inclusion criteria were randomized to either VCV or ASV group (Fig. 1). The randomization sequence was computer-generated, and
the assignments were placed in sealed opaque envelopes. The assignment to each arm was made on
admission by the attending physician. Blinding of
treatment was not possible.
Study procedure
Initially, all patients were passively ventilated (completely sedated and paralyzed) with low Vt strategy
(6 mL/kg predicted body weight) with FIO2/positive
end expiratory pressure (PEEP) as per the ARDSnet
protocol to determine the appropriate minute ventilation (MV).18,19 In patients randomized to VCV, the
same strategy was continued. The aim was to achieve
a SpO2 of 8892%, with the lowest FIO2 at a plateau
pressure (Pplat) of 3035 cm H2O and pH >7.3. The
Vt could be reduced to 4 mL/kg predicted body
weight and fR increased to 35/min to achieve these
goals if necessary.
In the ASV group, the minute ventilation attained
with initial VCV was used to guide the initial setting
of percentage MV (%MV). FIO2/PEEP was set according to ARDSnet protocol to maintain SpO2 of 8892%
at minimum possible FIO2. The peak pressure alarm
was set at 45 cm H2O to avoid Pplat from exceeding
35 cm H2O. Subsequent manipulation of %MV was
guided by interpretation of the following parameters:
Pinsp, spontaneous respiratory frequency while on
ASV (fspont) and target respiratory frequency (ftarget)
calculated by the ASV algorithm. If the fspont was
greater than ftarget by 10 breaths and/or associated
was hypoxaemia (PaO2 <55 mm Hg or SpO2 <88%) or
hypercapnic acidosis (pH <7.25), then the %MV was
escalated by 20%. If the fspont was similar to ftarget
without any hypercapnea or hypoxaemia, then the
%MV was de-escalated by 10%. The pressurization
slope (percentage of the inspiratory time taken to
reach the peak pressure) was maintained at 25% for
all subjects. All patients were ventilated with Galileo
Gold ventilators (Hamilton Medical, Bonaduz,
Switzerland).
Sedation protocol
A standard protocol was used in all patients. During
the first 48 h, all patients received intravenous midazolam infusion titrated to a Richmond AgitationSedation Scale (RASS) score of 0 to -2. Pain was
assessed using behavioural pain scale and managed
with intravenous fentanyl/morphine boluses.
Patients received vecuronium only if the fR was >35/
min or if there was significant patientventilator
Respirology (2013) 18, 11081115
1110
R Agarwal et al.
Figure 1 Algorithm depicting the entire protocol, from randomization of the patient to implementation of the two methods of
ventilation in patients with ARDS admitted to the respiratory ICU. ARDS, acute respiratory distress syndrome; ASV, adaptive support
ventilation; FIO2, fraction of inspired oxygen; fR, respiratory rate; VCV, volume-cycled ventilation; MV, minute ventilation; PBW,
predicted body weight, PEEP, positive end expiratory pressure; Pinsp, inspiratory pressure on ASV; Pplat, plateau pressure; PSVmax,
pressure support equal to the maximal plateau pressure while on VCV; SBT, spontaneous breathing trial; Vt, tidal volume.
Weaning protocol
Patients in the VCV arm were shifted to pressure
support (PS) ventilation once the PEEP and FIO2
Respirology (2013) 18, 11081115
requirements decreased to 8 cm H2O and 0.4, respectively (Fig. 1), according to our previously published
protocol.20 The PS used was the Pplat recorded during
the VCV mode (PSmax). PS was gradually decreased
by 2 cm H2O every 6 h (or earlier) until PS of 7 cm H2O.
Subsequently, the patient was given a spontaneous
breathing trial with T-piece (off ventilator) for 1 h. If
the patient tolerated the spontaneous breathing
trial,20 he or she was extubated. In the ASV arm,
weaning was initiated by monitoring the trends for
Pinsp, total fR and spontaneous/control fR. Once
deemed fit, weaning was achieved by sequential
decrease in %MV every 2 h (or earlier). Spontaneous
2013 The Authors
Respirology 2013 Asian Pacific Society of Respirology
1111
ASV in ARDS
Figure 2 CONSORT diagram demonstrating the flow of participants through each stage of the study. ARDS, acute respiratory distress
syndrome; ASV, adaptive support ventilation; VCV, volume-cycled ventilation; RICU, respiratory intensive care unit.
Statistical methods
Statistical significance was assumed at a P-value
<0.05. The categorical variables were analyzed using
chi-square test, while the continuous variables were
analyzed using MannWhitney U-test. The change in
variables over time was analyzed with repeated measures analysis of variance using the mixed linear
model.23 Survival curves were constructed to study
the effect of ventilator strategy on respiratory intensive care unit stay using KaplanMeier analysis, and
group differences were analyzed using the log-rank
test.
RESULTS
There were 352 respiratory intensive care unit admissions (227 patients received invasive ventilation, 43
patients received non-invasive ventilation (NIV), and
82 received oxygen therapy and ICU care for various
indications) during the study period. Seventy-three
(20.7%) patients were admitted with a diagnosis of
ARDS. Of these, seven patients had a duration of
illness of more than 7 days, six had contraindications
to permissive hypercapnea, and 12 had underlying
chronic lung disease and were excluded prior to randomization (Fig. 2). Forty-eight patients met the
inclusion criteria and were enrolled in the study.
There were 28 males and 20 females with mean
(standard deviation) age of 30 (13) years. Twenty-five
patients were randomized to the VCV arm and 23 to
the ASV group. Sepsis (29.2%) and communityacquired pneumonia (22.9%) were the most common
cause of ARDS (Table 1). A total of seven (14.5%)
Respirology (2013) 18, 11081115
1112
Table 1
R Agarwal et al.
Baseline characteristics of patients with acute respiratory distress syndrome (ARDS) included in the study
VCV (n = 25)
ASV (n = 23)
Total (n = 48)
P-value
29.7 (11.6)
13 (52)
162.6 (11)
58.4 (11.4)
17 (9.7)
8.2 (4.4)
31.4 (14.9)
15 (65.2)
163.8 (9)
59.4 (9.5)
17 (8.9)
7.4 (4.0)
30.5 (13.1)
28 (58.3)
163.2 (9.9)
58.9 (10.4)
17 (9.2)
7.8 (4.4)
0.67
0.35
0.66
0.74
1
0.47
6 (26.1)
5 (21.7)
3 (13.1)
5 (21.7)
4 (17.4)
14 (29.2)
11 (22.9)
10 (20.8)
7 (14.6)
6 (12.5)
0.65
0.85
0.36
0.35
0.59
8 (32)
6 (24)
7 (28)
2 (8)
2 (8)
5.6 (0.8)
12.1 (3.8)
30.9 (4.4)
26.5 (4.1)
6.6 (1.4)
12.6 (4.9)
30.5 (5.7)
26.6 (8.7)
6.1 (1.2)
12.4 (4.3)
30.7 (5)
26.5 (6.6)
0.005
0.70
0.79
0.95
7.27 (0.12)
96.6 (34.5)
44.3 (15.9)
7.29 (0.14)
107.3 (41.9)
40.7 (14.1)
7.28 (0.13)
101.8 (38.2)
42.6 (14.9)
0.50
0.34
0.41
APACHE, acute physiology and chronic health evaluation; ASV, adaptive support ventilation; CAP, community-acquired pneumonia;
HAP, hospital-acquired pneumonia; VCV, volume-cycled ventilation; PEEP, positive end expiratory pressure; PBW, predicted body
weight; Ppeak, peak pressure; Pplat, plateau pressure; SOFA, sequential organ failure assessment; TB, tuberculosis; Vt, tidal volume.
Table 2
6 (3.511.5)
9 (4.515.5)
11 (6.518.5)
1 (02.5)
15 (12.525)
18.3 (7.232.1)
6.2 (3.215.7)
1.4 (1.31.7)
ASV (n = 23)
5 (311)
8 (614)
11 (816)
2 (05)
25 (2030)
15 (8.925)
8.8 (5.218.8)
1.3 (1.11.5)
Total (n = 48)
P-value
5 (3.311)
8.5 (514.8)
11 (7.318)
1 (03.8)
0.51
0.9
0.97
0.54
20 (1525)
17.7 (7.827.3)
8.6 (3.315.9)
1.4 (1.21.6)
0.04
0.54
0.39
0.2
All values are represented as median (interquartile range) unless otherwise stated.
ABG, arterial blood gases; ASV, adaptive support ventilation; ICU, intensive care unit; VCV, volume-cycled ventilation; SOFA,
sequential organ failure assessment; VAS, visual analogue scale.
ASV in ARDS
1113
Figure 3 Time course of tidal volume, plateau pressures (peak inspiratory pressure in the ASV group), PEEP levels, static compliance,
pH and PaO2/FIO2 scores from baseline until day 14 in the two groups of patients. The dark circles represent patients in the
volume-controlled ventilation (VCV) group, while the hollow circles demarcate the adaptive support ventilation (ASV) group (*P < 0.05
between the two groups). RICU, respiratory intensive care unit.
DISCUSSION
The results of this study suggest that clinical outcomes with ASV are similar to VCV in managing
patients with ARDS. ASV was comparable to VCV in
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Respirology 2013 Asian Pacific Society of Respirology
1114
maintaining Pplat below 30 cm of H2O.18 This is the
first trial to report ARDS outcomes in patients solely
ventilated with ASV. In fact, the majority of evidence
regarding the use of ASV is for weaning postoperative patients2429 or chronic obstructive pulmonary
disease patients.30 The use of ASV in ARDS is conceptually appealing because it is a pressure-targeted
form of closed-loop ventilation that optimizes the
relationship between Vt and respiratory frequency
based on lung mechanics.8 ASV automatically determines the best Vt and fR that maintains the peak
pressure below the target level. Further, ASV by automatically adjusting airway pressure prevents the
adverse effects of excessive Pplat than a fixed tidal
volume.12 In a physiological study of total ventilatory
support in respiratory failure, ASV was found superior to conventional ventilation with regard to
haemodynamic, ventilatory and gas exchange
parameters, except for excessive Vt in few patients
with obstructive lung disease.31
In this study,Vt delivered by ASV were slightly higher
compared with VCV, albeit the Pplat was comparable
on most days and so were the other end-points. In the
ASV mode, we measured only the Pinsp and not the
Pplat. In ASV, the alveolar pressure can be considered
equal to Pinsp only when inspiratory time is adequate
for inspiratory flow to reach zero, in which circumstance there is no pressure gradient between proximal
airway pressures and alveolar pressure. However, such
a setting is not possible with ASV; as such, the Pplat
may actually be lower in the ASV group.
Studies designed specifically to compare ASV with
VCV have suggested conflicting results with the ASV
strategy.12,13 In a study comparing ASV with VCV, the
inspiratory and expiratory Vt and expiratory resistance were higher, while the total fR and maximum
pressure were lower with ASV. No changes in the arterial blood gases, heart rate or mean arterial pressure
were observed.13 In contrast, another study found ASV
to deliver lower Vt compared with VCV.12 Earlier
studies have also reported higher VtfR ratios in
patients ventilated with ASV.11,32,33 In a study that
evaluated only the breathing pattern, ASV was found
to deliver Vt at a range of 4.810 mL/kg in patients
with restrictive lung disease.31 As ASV manipulates the
ventilator with each breath, the number of interventions by the physician and the alarms are likely to be
lesser, although this was not particularly evaluated in
the current trial.
ASV reopens the debate of pressure versus volume
ventilation in the management of ARDS, although
data supporting the use of either approach are
equivocal.3438 The ARDS network trial used volume
ventilation in both arms.18 Studies comparing the
effects of pressure versus volume ventilation have
not been well designed.39 However, the advent of
closed-loop mechanical ventilation now combines
the best characteristics of both pressure and volumecontrolled ventilation.19 Regardless of the mode used,
the emphasis of ventilation has shifted to supportive
care and prevention of aggravation of lung injury
rather than cure of ARDS. This study suggests that
ASV could be a viable alternative to VCV in the management of ARDS.
Respirology (2013) 18, 11081115
R Agarwal et al.
The strength of the current study includes its randomized nature, ASV as a primary mode of ventilation
and the comparison of clinical outcomes for up to 2
weeks following randomization. The limitations
include the small study sample, conducted at a single
centre and the unblinded nature of the study. Further,
we collected only hospital mortality and not 28-day or
90-day survival, which are better descriptors of
outcome. Although the attending physicians found
VCV easier to use than ASV, this difference reflects
mere statistical significance as the scores were low in
both the groups. The other reason could be the unfamiliarity, as the mode was in practice only for 1 year
prior to this trial. Specific training of the intensivists
on how to best set the ASV is an important issue,
which should be considered in any future trial involving ASV.
In conclusion, this study found no difference in the
outcomes in patients with ARDS ventilated with
either ASV or VCV with regard to the duration of
medical care, morbidity or mortality. Larger clinical
studies are warranted to clarify the role of ASV as a
primary mode for ventilation in ARDS.
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