Helmet CPAP in community acquired pneumonia with ... - HAROL Srl

ORIGINAL ARTICLE
ARTICOLO ORGINALE
9
RASSEGNA DI PATOLOGIA DELL’APPARATO RESPIRATORIO 2006;21:9-13
Helmet CPAP in community acquired pneumonia
with acute respiratory failure
CPAP scafandro nella polmonite comunitaria
con insufficienza respiratoria acuta
S. POLTI, G. MEREGALLI, G. MESSINESI, F. TANA
Division of Respiratory Diseases, University of Milano-Bicocca, “San Gerardo” Hospital, Monza
Key words
Acute respiratory failure • Community acquired pneumonia
• Continuous positive airway pressure • Helmet
Summary
Introduction
Severe community acquired pneumonia (CAP) is a common
disease characterized by high mortality due to respiratory failure,
which requires treatment in intensive care unit (ICU). For
almost 20 years at San Gerardo Hospital continuous positive
airway pressure (CPAP) has been delivered in respiratory distress
by helmet, easier to use than face or nasal mask.
Aim
The aim of this study is to evaluate the efficacy of helmet
CPAP method in acute respiratory failure (ARF) due to CAP.
Methods
Clinical records between January 2002 and December 2004
were collected retrospectively on 19 patients (16 males, 3 females;
mean age 60 years) with severe CAP and ARF, characterized
by a chest X-ray showing a multilobar disease, a respiratory
rate > 30 breaths/min and a PaO 2/FiO 2 ratio < 200. All
those patients matched the American Thoracic Society (ATS)
criteria for severe CAP and need for ICU care. The patients
were treated in the ward with CPAP delivered by Helmet and
antibiotics (protected penicillins or third generation
cephalosporins, both associated with macrolides).
Results
All 19 subjects included in this study showed statistically significant
improvement of PaO 2 and respiratory rate when O 2 administration
with bag mask was replaced by helmet CPAP,
while PaCO 2 showed no significative changes. Four patients
(21%) required to be transferred to ICU after some hours or
few days; two of them (10.5%) needed intubation, one (5%)
pressure support ventilation; two patients (10.5%) died.
Parole chiave
Insufficienza respiratoria acuta • Polmonite comunitaria •
Pressione positiva continua delle vie aeree • Scafandro
Riassunto
Introduzione
La polmonite comunitaria (CAP) grave è una malattia
comune caratterizzata da un’alta mortalità dovuta a insufficienza
respiratoria, che richiede trattamento in terapia
intensiva (ICU). Da diversi anni all’Ospedale “S. Gerardo”
di Monza nell’insufficienza respiratoria si utilizza la pressione
positiva continua delle vie aeree (CPAP) in scafandro,
più semplice da utilizzare delle maschere facciali o nasali.
Scopo
Lo scopo di questo studio è valutare l’efficacia della CPAP
in scafandro nell’insufficienza respiratoria acuta (ARF)
dovuta a polmonite comunitaria.
Metodi
Sono state valutate retrospettivamente le cartelle cliniche
del periodo tra Gennaio 2002 e Dicembre 2004 di 19
pazienti (16 maschi, 3 femmine, età media 60 anni) con
CAP severa e ARF, caratterizzata da polmonite a focolai
multipli documentata alla radiografia del torace, frequenza
respiratoria > 30 atti/min e rapporto PaO 2/FiO 2 < 200.
Tutti i pazienti soddisfacevano i criteri dell’American
Thoracic Society (ATS) di polmonite comunitaria severa
con necessità di trattamento in terapia intensiva. Questi
pazienti sono stati trattati con CPAP in scafandro (ditta
produttrice Harol) ed antibiotici (penicilline protette o cefalosporine
di III generazione in associazione a macrolidi).
Risultati
Tutti i 19 pazienti inclusi nello studio dimostrarono un
miglioramento statisticamente significativo della PaO 2 e
della frequenza respiratoria quando la somministrazione di

Introduction
S. POLTI ET AL.
Conclusions
The results of the study look encouraging and C-PAP helmet
seems to be helpful when added to standard treatments in ARF
due to CAP, avoiding the ICU transfer in most cases. Further
studies are required to better back up these results.
Severe community acquired pneumonia (CAP) is a
common disease characterized by high mortality
(from 5% to 36% of patients admitted to hospital) 1-4 .
From 10% to 36% of patients admitted to the hospital
need to be transferred to intensive care unit (ICU)
2 5 6 , because of acute respiratory failure, and among
them from 20% to 76% die 1 2 7-10 . Invasive mechanical
ventilation is required in 70% to 85% of the patients
admitted to ICU. Non invasive ventilation
(NIV) is widely used to support patients with various
forms of acute respiratory failure. The aim is to
avoid endotracheal intubation and its side effects
(tracheal injury and ventilation-associated pneumonia).
Otherwise only few studies investigated the
used of NIV in CAP.
Though continuous positive airway pressure (CPAP)
cannot properly be called a ventilatory support
mode, CPAP is frequently used to provide NIV, and
has been proved to be effective in hypoxaemic acute
respiratory failure (ARF) of patients with a preserved
respiratory muscle function. CPAP can be administered
without the use of expensive ventilators
by simple and cheap systems, which make non-invasive
CPAP very easy to apply, particularly in setting
outside of the ICU.
In San Gerardo Hospital (Monza, Italy), for several
years, continuous positive airway pressure has been
delivered through a peculiar helmet made of transparent
plastic material (producer: Harol) allowing
the extensive use of CPAP to patients affected by
thoracic trauma, atelectasis, acute pulmonary oedema.
This device is not expensive and better tolerated
than face mask, providing same result and effects.
It can be used in the general ward without the
need for an ICU stay. Considering the favourable
outcome in above mentioned diseases, helmet has
been tested in acute respiratory failure due to pneumonia.
The aim of this retrospective study is to evaluate the
efficacy of the described device in the treatment of
CAP, when added to the usual medical treatment.
O 2 tramite maschera con reservoir venne sostituita dalla
CPAP in scafandro, mentre non si osservarono significative
variazioni della PaCO 2. Quattro pazienti (21%) richiesero
il trasferimento in ICU dopo alcune ore o pochi giorni,
due di loro (10,5%) furono intubati, uno (5%) fu ventilato
con ventilazione non invasiva in pressione di supporto; due
(10,5%) morirono.
Conclusioni
I risultati dello studio appaiono incoraggianti e la CPAP
in scafandro sembra essere utile quando aggiunta ai trattamenti
standard nell’ARF dovuta a CAP, evitando il trasferimento
in ICU nella maggior parte dei casi. Ulteriori studi
sono richiesti per avvalorare questi risultati.
Materials and methods
Clinical records of all patients affected by CAP and
acute respiratory failure, in the period between January
2002 and December 2004 in “S. Gerardo” Hospital,
have been collected and retrospectively analysed:
patients treated by helmet CPAP admitted in respiratory,
medical and geriatric units (i.e. not-intensive
care units) were considered. Patients were admitted
to helmet CPAP treatment considering the following
eligibility criteria: absence of COPD and severe systemic
disease, chest X-ray showing a multilobar
pneumonia, acute respiratory failure diagnosed on
basis of both criteria respiratory rate > 30
breaths/min (during breathing in air) and PaO 2/FiO 2
(arterial oxygen tension/inspiratory oxygen fraction)
ratio < 200 (during use high flow oxygen ≥ 15 l/min
delivered with bag mask we estimated FiO 2 ≅ 60%).
All the patients considered were affected by severe
CAP and need for ICU stay according to ATS criteria 10 .
The following end-points have been considered:
• respiratory parameters (PaO 2, PaCO 2, pH, respiratory
frequency) breathing in air (FiO 2 21%),
with high flow oxygen (≥ 15 l/min) delivered
with bag mask (FiO 2 estimated 60%), and in helmet-CPAP
(FiO 2 100%);
• need to transfer to ICU, in patients worsening during
treatment (respiratory rate > 30 breaths/min,
PaO 2/FiO 2 ratio < 200, CO 2 increasing > 20% in
relation to basal value while receiving C-PAP) or
matching the clinical criteria suggested in literature
to judge the failure of the non invasive ventilation:
respiratory arrest, cardiac failure, loss of
consciouness or mental status worsening due to
hypoxemia, psychic excitement requiring sedative
drugs, haemodynamic instability;
• intubation actually occurred;
• death of the patient.
Following the above mentioned criteria 19 patients
(16 males, 3 females; mean age 60 ± 13 years) were
selected.
The functional parameters at admission were the following
(Tab. 1): PaO 2 48 ± 9 mmHg, PaCO 2 33 ± 3
10

Tab. 1. Functional parameters of patients at the admission
in hospital, before O 2 therapy. Parametri funzionali dei
pazienti all’ammissione in Ospedale, prima della somministrazione
di ossigeno terapia.
Parameter Mean SD
Age 60 13
Respiratory rate (breath/min) 35 4
Systolic Pressure (mmHg) 133 21
Diastolic Pressure (mmHg) 78 11
Urea (mg/dl) 47 25
pH 7.41 0.06
P aO 2 (mmHg) 48 9
P aCO 2 (mmHg) 33 3
SAPS II 27 9
APACHE 12 4
SD: standard deviation
mmHg, ph 7.4 ± 0.06 breathing room air; respiratory
rate (RR) 35 ± 4 breaths/min; SAPS score 27 ± 9;
APACHE score 12 ± 4.
During O 2 administration by bag mask all of the patients
reached respiratory frequency > 30 breaths/min
and PaO 2/FiO 2 ratio < 200, and were successively
treated using helmet CPAP (produced by Harol s.r.l.,
San Donato Milanese, MI, Italy). The mean value of
the CPAP pressure was 7.03 ± 1.2 cm H2O, FiO 2 was
100% in all cases.
Only patients with gas analysis results and clinical
data available after three hours of CPAP treatment
have been considered.
Seven patients denied previous diseases, three were
affected with hypertension, one had diabetes mellitus
and hypertension, one diabetes mellitus alone, three
had ischemic cardiopathy, one dilatative cardiopathy,
one vascular encephalopathy.
Systolic mean pressure was 133 ± 21 mmHg, diastolic
mean pressure was 78 ± 11 mmHg; two patients
had systolic pressure < 80; no one of them had shock.
Mean blood urea was 47 ± 25 mg/dl; eight patients had
renal failure, with 45 mg/dl < blood urea < 100 mg/dl.
11
HELMET CPAP IN COMMUNITY ACQUIRED PNEUMONIA
All patients have been treated with broad spectrum
antibiotics (protected penicillins or third generation
cephalosporins, both associated with clarithromycin).
The aetiology of CAP was identified on serum examination
in only three patients: in two cases Legionella
pneumoniae, once Mycoplasma pneumoniae. Sputum
culture was negative in all cases. The patients
were admitted in non ICU wards (medicine, respiratory
or geriatric ward) but were carefully followed
and transferred to ICU when needed according to the
above mentioned criteria.
Results
An improvement of respiratory parameters (PaO 2,
PaO 2/FiO 2, respiratory rate) using helmet CPAP was
observed in all patient, as shown in Table 2.
PaO 2/FiO 2 ratio improved in 17 (89%) cases, rising
in 13 subjects (68%) over 200, and these improvement
were statistically significative when compared
with breathing room air and bag-mask. No statistically
significative changes were noted in PaCO 2 parameter
comparing the three groups.
4 patients (21%) need to be transferred to ICU: 3
(15%) needed intubation according to ATS criteria;
two out of three (10,5%) were intubated; the third one
(5%) was treated by non invasive ventilation (face
mask) and pressure support. Two of the nineteen patients
(10.5%) died (both were in the group who need
ICU transfer).
CPAP-helmet administration ranged from 2 to 18
days; daily CPAP-helmet hours ranged from 8 to 24
hours (mean 13 ± 5).
Helmet-CPAP was well-tolerated in all cases; two patients
complained about gastric inflation and sickness
needing the placement of a nose-gastric tube; in one
case agitation and panic rose. Nevertheless treatment
with helmet-CPAP was not withdrawn.
Discussion
The characteristics of this study (retrospective, no
control group or randomization) limit the significance
Tab. 2. Effect of the different treatments on blood gases and respiratory rate (statistical significance p < 0.05). Further explanations
in the text. Effetto dei diversi trattamenti sui gas ematici e frequenza respiratoria (significatività statistica p < 0,05). Ulteriori
spiegazioni nel testo.
Parameter Breathing room air p value Bag mask p value Helmet-CPAP
P aO 2 48 ± 9 < 0,001 70 ± 16 < 0,001 190 ± 87
P aO 2/F iO 2 Not applicable NS 145 ± 28 < 0,001 198 ± 85
resp. rate 35 ± 4 NS 32 ± 45 < 0,05 27 ± 5
CO2 33 ± 3 NS 34 ± 8 NS 32 ± 5

S. POLTI ET AL.
of its results, otherwise the role of NIV in severe CAP
remains unclear, and few reports are present in literature
most of them regarding pressure support ventilation
plus CPAP delivered by face mask.
Confalonieri et al. (11) in a randomised controlled trial
(RCT) used NIV delivered by a face mask in ARF
due to CAP with benefits on respiratory rate, need for
ETI and duration of ICU stay, but some of the patients
were affected by COPD and this may have influenced
the results. Meduri et al. 12 stated selection
criteria as the current study. They found that 36%
(4/11) of the patients ventilated in pressure support
through a facial mask needed afterwards intubation
and that 45% (5/11) died.
Antonelli et al showed that NIV can be delivered to
immunocompromised patients with ARF with an improvement
of blood gases and a reduction of endotracheal
intubation, fatal complications and ICU
mortality rate 13 14 . Furthermore the Authors showed
that CAP is an indipendent risk factor of failure of
NIV 15 . Navalesi et al. 16 emphasized the importance
of the ventilatory interface during NIV.
In the last years, the helmet have been tested in different
NIV techniques 17 .
Brett et al. 18 evaluated the effect of CPAP administered
through a facial mask in CAP; the sample included
only three patients whose PaO 2 and comfort
improved during the therapy.
Antonelli and Conti showed the helmet to be effective
as face mask in delivering NIV, with less side effects
19 20 , allowing to use NIV for longer periods.
Antonelli, Pennisi et al showed that non invasive
pressure support ventilation through the helmet allows
a safe diagnostic bronchoscopy with BAL in patients
with hypoxemic ARF, avoiding gas exchange
deterioration, and endotracheal intubation 21 .
In the present study, in patients affected from CAP and
consequent acute respiratory failure, the administration
of CPAP through a helmet improves PaO 2 and reduces
respiratory rate significantly in comparison with
high oxygen flow administered through a bag mask at
atmospheric pressure; furthermore the mortality and
the percentage of patients who needed intubation was
low. Using ATS criteria all patients included in the series
should be transferred to intensive care unit.
The helmet CPAP treatment resulted in ICU transfer
rate of only 21% of patients; the remaining 79% were
treated in non ICU wards, being strictly monitorated
with the opportunity of a prompt transfer to ICU
when needed.
The device has proved to be reliable, as well as simple
and cheap; side effects were rare and no severe
adverse event related to the helmet use has been registered.
From physiopathological prospective, most
important data concern the effect of helmet CPAP in
changing PaO 2, PaO 2/FiO 2 ratio and the respiratory
rate. Hypoxemia is the main factor in causing sys-
Fig. 1. Patient treated with Helmet C-PAP. Paziente trattato
con C-PAP scafandro.
temic and organ damages; in pneumonia it depends
on atelectasis and alveolar hepatization, which induces
ventilation/perfusion mismatching increasing
shunt areas. Furthermore alveolar walls inflammatory
infiltration and oedema worsen oxygen diffusion
from alveolar spaces to capillary blood. CPAP is likely
to reduce the extracellular water in lung tissue and
consequently the alveolar-capillary O 2 tension difference,
improving the oxygen transit to alveoli.
We didn’t observe any increase of CO 2: with a high
flow of oxygen through the helmet the re-breathing
of CO 2 is negligible 22 , and because our patients were
without COPD we could use high FiO 2 without any
problem. Of course helmet system allows to reduce
the FiO 2 delivered when appropriate.
CPAP possibly assists the removal of bronchial secretions:
airway conductance and consequently ventilation
of open pulmonary zones increase.
Face-mask could be associated with patient discomfort,
air leaks, and skin lesion that limits the application,
especially when applied continuously for long
term periods. The helmet is made of a transparent
hood that contains the entire head of the patient, and
the hood is joined by means of a rigid ring to a latexfree
collar that provides the seal around the neck. So
it prevents the discomfort due to facial tissue trauma,
avoiding skin necrosis and pain improving patient’s
tolerance. In effect CPAP can be administered for a
long time (several days, if required), and is better tolerated
by the patient. Furthermore it can be considered
simple and easy to use. Recently, it was reported
a positive effect of hydrocortisone infusion in patients
with severe community acquired pneumonia 23 .
This therapeutic intervention is not scheduled on our
institution, so we did not considered the influence of
corticosteroids therapy on our patient population.
We conclude that the use of helmet CPAP should be
carefully considered in the treatment of respiratory
failure in pneumonia. Further studies are required to
better back up this results.
12

References
1 Rello J, Quintana E, Ausina V.
A three-year study of severe community-acquired pneumonia
with emphasis on outcome.
Chest 1993;103:232-5.
2 Moine P, Vercken JB, Chevret S, Chastang C, Gajdos P.
Severe community-acquired pneumonia. Etiology, epidemiology,
and prognosis factors.
Chest 1994;105:1487-95.
3 Fine MJ, Smith MA, Carson CA, Mutha SS, Sankey SS, et
al.
Prognosis and outcomes of patients with community-acquired
pneumonia.
JAMA 1995;274:134-41.
4 Ewig S, Ruiz M, Mensa J, Marcos MA, Martinez JA, Arancibia
F, et al.
Severe community-acquired pneumonia. Assessment of severety
criteria.
Am J Respir Crit Care Med 1998;158:1102-8.
5 Marriet J, Durant H, Yates L.
Community-acquired pneumonia requiring hospitalization:
5-year prospective study.
Rev Infect Dis 1989;11:586-99.
6 Sorensen J, Forsberg P, Hakanson E, Maller R, Sederholm
C, Soren L, et al.
A new diagnostic approach to the patient with severe pneumonia.
Scand J Infect Dis 1989;21:24-31.
7 Torres A, Serra-Batles J, Ferrera T.
Severe community-acquired pneumonia: epidemiology and
prognosis factors.
Am Rev Respir Dis 1991;114:312-8.
8 Leroy O, Santre C, Beuscart C, Georges H, Guery B,
Jacquier JM, et al.
A five-years study of severe community-acquired pneumonia
with emphasis on prognosis in patients admitted to an
intensive care unit.
Intens Care Med 1995;21:24-31.
9 Leeper KV, Torres A.
Community-acquired pneumonia in the intensive care unit.
Clinics Chest Med 1995;16:155-71.
10 American Thoracic Society.
Guidelines for the Management of Adults with Communityacquired
Pneumonia.
Am J Respir Crit Care Med 2001;163:1730-54.
11 Confalonieri M, Potena A, Carbone G, Porta RD, Tolley
EA, Meduri GU.
Acute respiratory failure in patients with severe community
acquired pneumonia. A prospective randomized evaluation
on noninvasive ventilation.
Am J Respir Crit Care Med 1999;160:1585-91.
12 Meduri GU, Turner RE, Abou-Shala N, Wunderink R, Tol-
ley E.
Noninvasive positive pressure ventilation via face mask:
first line intervention in patients with acute hypercapnic
and hypoxemic acute respiratory failure.
Chest 1996;109:179-93.
13 Antonelli M, Conti G, Bufi M, Costa MG, Lappa A, Rocco
M, et al.
Noninvasive ventilation for treatment of acute respiratory
failure in patients undergoing solid organ transplantation.
13
HELMET CPAP IN COMMUNITY ACQUIRED PNEUMONIA
JAMA 2000;283:235-42.
14 Rabitsch W, Schellongowski P, Kostler WJ, Stoiser B,
Knobl P, Locker GJ, et al.
Efficacy and tolerability of non-invasive ventilation delivered
via a newly developed helmet in immunosuppressed
patients with acute respiratory failure.
Wien Klin Woschenschr 2003;15:590-4.
15 Antonelli M, Conti G, Moro ML, Esquinas A, Gonzalez-Diaz
G, Confalonieri M, et al.
Predictors of failure of non invasive positive pressure ventilation
in patients with acute hypoxemic respiratory failure:
a multi centre study.
Intensive Care Med 2001;27:1718-28.
16 Navalesi P, Fanfulla F, Frigerio P, Gregoretti C, Nava S.
Physiologic evaluation of non invasive mechanical ventilation
delivered with three types of masks in patients with
chronic hypercapnic respiratory failure.
Crit Care Med 2000;28:1785-90.
17 Scandroglio M, Piccolo U, Mazzone E, Agrati P, Aspesi M,
Gamberoni C, et al.
Use and nursing of helmet in delivering NIV.
Minerva Anestesiol 2002;68:475-80.
18 Brett A, Sinclair DG.
Use of continuous positive airway pressure in the management
of community acquired pneumonia.
Thorax 1993;48:1280-1.
19 Antonelli M, Conti G, Pennisi P.
Successful and prolonged application of non invasive pressure
support ventilation by Helmet in patients with ARDS.
Intensive Care Med 2002;Suppl.28:78.
20 Antonelli M, Conti G, Pelosi P, Gregoretti C, Pennisi MA,
Costa R, et al.
New treatment of acute hypoxemic repiratory failure: non
invasive pressure support ventilation delivered by Helmet –
a pilot controlled trial.
Crit Care Med 2002;30:602-8.
21 Antonelli M, Pennisi MA, Conti G, Bello G, Maggiore SM,
Michetti V, et al.
Fiberoptic bronchoscopy during non invasive positive pressure
ventilation delivered by helmet.
Intensive Care Med 2003;29:126-9.
22 Patroniti N, Foti G, Manfio A, Coppo A, Bellani G, Pesenti
A.
Head helmet versus face mask for non-invasive continuous
positive airway pressure: a physiological study.
Intensive Care Med 2003;29:1680-7.
23 Confalonieri M, Urbino R, Potena A, Piattella M, Parigi P,
Puccio G, et al.
Hydrocortisone infusion in patients with severe community
acquired pneumonia: a preliminary randomized study.
Am J Resp Crit Care Med 2005;171:242-8.
Pervenuto il 7/7/2005
Accettato dopo revisione 16/12/2005
Correspondence: Guglielmo Meregalli, Division of Respiratory
Diseases, “San Gerardo” Hospital, via Donizetti 106, 20052
Monza (MI), Italy. E-mail: guglielmomeregalli@hotmail.com