Beruflich Dokumente
Kultur Dokumente
Louis Ayzac, MD Objective To determine whether prone positioning improves mortality in ARF pa-
tients.
Raphaele Girard, MD
Design, Setting, and Patients Prospective, unblinded, multicenter controlled trial
Pascal Beuret, MD of 791 ARF patients in 21 general intensive care units in France using concealed ran-
Bruno Palmier, MD domization conducted from December 14, 1998, through December 31, 2002. To be
included, patients had to be at least 18 years, hemodynamically stable, receiving me-
Quoc Viet Le, MD chanical ventilation, and intubated and had to have a partial pressure of arterial oxy-
Michel Sirodot, MD gen (PaO2) to fraction of inspired oxygen (FIO2) ratio of 300 or less and no contrain-
Sylvaine Rosselli, MD dications to lying prone.
Interventions Patients were randomly assigned to prone position placement
Vincent Cadiergue, MD
(n = 413), applied as early as possible for at least 8 hours per day on standard beds, or
Jean-Marie Sainty, MD to supine position placement (n=378).
Philippe Barbe, MD Main Outcome Measures The primary end point was 28-day mortality; second-
Emmanuel Combourieu, MD ary end points were 90-day mortality, duration of mechanical ventilation, incidence
of ventilator-associated pneumonia (VAP), and oxygenation.
Daniel Debatty, MD
Results The 2 groups were comparable at randomization. The 28-day mortality rate
Jean Rouffineau, MD was 32.4% for the prone group and 31.5% for the supine group (relative risk [RR],
Eric Ezingeard, MD 0.97; 95% confidence interval [CI], 0.79-1.19; P=.77). Ninety-day mortality for the
prone group was 43.3% vs 42.2% for the supine group (RR, 0.98; 95% CI, 0.84-
Olivier Millet, MD 1.13; P=.74). The mean (SD) duration of mechanical ventilation was 13.7 (7.8) days
Dominique Guelon, MD for the prone group vs 14.1 (8.6) days for the supine group (P=.93) and the VAP in-
Luc Rodriguez, MD cidence was 1.66 vs 2.14 episodes per 100-patients days of intubation, respectively
(P=.045). The PaO2/FIO2 ratio was significantly higher in the prone group during the
Olivier Martin, MD 28-day follow-up. However, pressure sores, selective intubation, and endotracheal tube
Anne Renault, MD obstruction incidences were higher in the prone group.
Jean-Paul Sibille, MD Conclusions This trial demonstrated no beneficial outcomes and some safety con-
cerns associated with prone positioning. For patients with hypoxemic ARF, prone po-
Michel Kaidomar, MD sition placement may lower the incidence of VAP.
JAMA. 2004;292:2379-2387 www.jama.com
P
RONE POSITIONING WAS ADVO-
cated 30 years ago1 to improve
oxygenation in patients with The mechanism of how the prone posi- Author Affiliations are listed at the end of this
article.
hypoxemic acute respiratory tion improves oxygenation in this set- Corresponding Author: Claude Guerin, MD, Service
failure (ARF) receiving mechanical ven- ting is still unclear. Postulated hypoth- de Réanimation Médicale, Hôpital De La Croix-
tilation. Dramatic oxygenation improve- eses in humans include alveolar Rousse, 103 Grande rue de la Croix Rousse, 69004
Lyon, France (claude.guerin@chu-lyon.fr).
ment using prone positioning was re- recruitment,3 redistribution of ventila- Caring for the Critically Ill Patient Section Editor: Debo-
ported in severely hypoxemic patients.2 tion4 toward dorsal areas that remain well rah J. Cook, MD, Consulting Editor, JAMA.
©2004 American Medical Association. All rights reserved. (Reprinted) JAMA, November 17, 2004—Vol 292, No. 19 2379
perfused,5 homogenization of tidal vol- also showed no significant improve- venous thrombosis (to minimize risk for
ume (VT) distribution as a result of a bet- ment in patient outcome.14 pulmonary embolism from being in a
ter fitting of the lungs with the chest We designed this protocol in 1997 be- prone position), pacemaker inserted for
wall,6 and redirection of compressive fore the results of the trial by Gattinoni fewer than 2 days, and unstable frac-
force exerted by heart weight on lungs et al13 were reported. At that time, the in- ture; (3) therapeutic limitation indi-
toward the sternum.7 In addition prone tensive care unit (ICU) mortality of hy- cated in the first 24 hours of ICU admis-
positioning has a drainage effect of res- poxemic ARF in intubated patients, as sion; (4) high risk of death in the next
piratory secretions, which has not been definedasapartialpressureofarterialoxy- 48 hours; (5) chronic respiratory fail-
systematically investigated. Whereas gen (PaO2) to fraction of inspired oxygen ure requiring mechanical ventilation; and
most experience with the prone posi- (FIO2) ratio of 300 or less, from various (6) inclusion in another protocol with
tion has been for patients with acute lung etiologies, was 41% in France.15 We se- mortality as a primary end point.
injury (ALI) or acute respiratory dis- lected 8-hour prone position sessions be-
tress syndrome (ARDS), oxygenation cause no clearly optimal time frame had Design
may also improve using the prone posi- yet been determined. Also, prone posi- The patients were consecutively re-
tion for other serious respiratory ill- tion sessions as short as 4 hours resulted cruited from 21 ICUs in France. The par-
ness, such as chronic obstructive pul- insignificantoxygenationimprovement.8 ticipating centers had used this maneu-
monary disease8,9 or acute cardiogenic We chose to investigate the effect of ver for more than a year. Before inclusion,
pulmonary edema.10 prone position placement to outcome in each center had been formally visited by
In patients with chronic obstruc- unselected patients with hypoxemic ARF 2 of us (S.G. and C.G.) during rounds
tive pulmonary disease, the improve- to delineate the role of prone position- and interview the nursing and physi-
ment of oxygenation from prone posi- ing in the management of hypoxemic pa- cian staff about prone positioning prac-
tion placement was associated with a tients. Prone positioning has been rou- tice and assess interest in the trial. The
reduction in static lung elastance,9 sug- tinely used in several centers, such as randomization was computer-gener-
gesting that tidal ventilation was oper- ours, for many years, not only in ARDS ated and separately generated for each
ating above closing volume. In pa- patients16 but also in comatose patients ICU. Patients were randomly assigned to
tients with cardiogenic pulmonary mechanically ventilated without signifi- the prone position or the supine posi-
edema, oxygenation improvement may cant hypoxemia.17 Accordingly, the ob- tion group using sequentially num-
result from less lung compression by the jective of this study was to determine bered, opaque, and sealed envelopes.
heart, which is frequently enlarged in whether systematic use of prone posi- The protocol was approved by an eth-
this condition. Therefore, translation of tion in patients receiving mechanical ven- icscommittee(ComitéConsultatifdePro-
these physiological effects into clini- tilation with hypoxemic ARF from vari- tection des Personnes dans la Recherche
cal benefits, ie, reduction in mortality, ous etiologies would decrease mortality. Biomedicale Lyon B, Lyon, France) on
was expected. Speculated mecha- March 18, 1998. Written informed con-
nisms for this can be reduction in the METHODS sent was read and signed by patients’ sur-
length of mechanical ventilation and, Patients rogateineveryinstance.Oncepatientsim-
hence, of its associated adverse ef- Patients were considered eligible if they proved to the point at which they could
fects, such as nosocomial infections and met all the following criteria: mechani- readawritteninformedconsent,theywere
reduction of ventilator-induced lung in- cal ventilation through either oral or nasal approached to confirm trial participation.
jury11 and multiple organ failure.12 tracheal intubation or tracheostomy; a A register of admissions to ICUs was
However, in a randomized con- PaO2/FIO2 of 300 or less; at least 18 years; maintained, recording the reason for non-
trolled trial, Gattinoni et al13 found that expected duration of mechanical venti- inclusion of eligible patients. An inves-
patients with ALI experienced no clini- lation of longer than 48 hours; and writ- tigator in each center was responsible for
cal benefit from prone position place- ten informed consent obtained from next including the patients following the pro-
ment. This may be due to insufficient sta- of kin. Patients were excluded for any of tocol and completing the case record
tistical power resulting from an following reasons: (1) prone position for forms (CRFs). The trial was monitored
interruption of enrollment before reach- at least 6 hours per day in the 4 days pre- by 2 research fellows (S.G., S.L.) who
ing the required number of patients ceding enrollment; (2) contraindica- made periodic site visits. Data collec-
(prone position group, 152; control tions to prone position, such as intra- tors and outcomes assessors were not
group, 152) or because the average of 7 cranial pressure of more than 30 mm Hg blinded. The trial was overseen by a steer-
hours per day that patients were in the or cerebral perfusion pressure of less than ing committee that convened monthly
prone position may have been an insuf- 60 mm Hg, massive hemoptysis, bron- meetings.
ficient amount of time to determine ef- cho-pleural fistula, tracheal surgery or
ficacy. Another randomized controlled sternotomy in the last 15 days, mean arte- Protocol
trial of prone position in ARDS patients rial blood pressure of less than 65 mm Hg After verification of eligibility, pa-
(only reported in abstract form to date) with or without vasopressors, deep- tients were allowed a 12- to 24-hour pe-
2380 JAMA, November 17, 2004—Vol 292, No. 19 (Reprinted) ©2004 American Medical Association. All rights reserved.
prone group (relative risk [RR], 0.97; duce mortality and was associated with
Table 2. Cointerventions at Inclusion
95% confidence interval [CI], 0.79- harmful effects although it improved
No. (%) of Patients
1.19; P=.77; TABLE 3). The estimate of oxygenation and reduced the inci-
Supine Prone survival (FIGURE 2) was not different be- dence of VAP.
Position Position
Cointervention (n = 378) (n = 413) tween the groups. At day 28, 83 (27.9%) However, several limitations must be
Continuous intravenous 351 (92.9) 393 (95.2) of 297 patients in the supine group died, acknowledged. First, most hypoxemic
sedation 36 (44.4%) of the 81 patients who had patients assigned to the supine group
Vasopressor/ 287 (75.9) 292 (70.7) crossed over from the supine group were allowed to be placed in the prone
inotropic agents
Enteral nutrition 138 (36.5) 148 (35.8) died, 76 (31.3%) of 243 patients in the position. When the protocol was
Parenteral nutrition 91 (24.1) 98 (23.7) prone group died, and 58 (34.1%) of designed, even though the effect of prone
Neuromuscular 79 (20.9) 85 (20.6)
blockade 170 patients who crossed over from the positioning on patient outcome was not
Pulmonary artery 56 (14.8) 59 (14.3) prone group died (P=.85). proven, coinvestigators considered it
catheter
Inhaled nitric oxide 41 (10.8) 37 (9.0) unethical not to allow severely hypox-
Renal replacement 16 (4.2) 21 (5.1) Secondary End Points emic patients to be placed in a prone posi-
therapy
Intravenous almitrine 7 (1.9) 8 (1.9)
Crude 90-day mortality rates were 42.2% tion. Second, mechanical ventilation was
in the supine group and 43.3% in the not performed using a predetermined
Baseline prone group (RR, 0.98; 95% CI, 0.84- algorithm. This can be explained because
Baseline characteristics were not signifi- 1.13; P=.74; Table 3). The 90-day mor- present protocol was set up in 1997 and
cantly different between groups tality was 39.2% in the supine group, 1998 before results of the ARDSnet trial27
(TABLE 1). Mechanical ventilation was 53.1% in patients who crossed over to were available. Hence, mechanical ven-
delivered through an oral route in 93.1% the prone group, 40.3% in prone group, tilation practice in our trial was at the dis-
of those in the supine group and in 90.8% and 47.6% in patients who crossed over cretion of each center. However, per cen-
of those in the prone group (P=.39). The to the supine group (P=.83). Mechani- ter randomization should have balanced
numbers of patients treated with hemo- cal ventilation length and successful extu- this factor between groups. Third, we
dialysis, inotropic support, sedation, neu- bation rate were not statistically signifi- planned that patients assigned to the
romuscular blockade, enteral or paren- cantly different. Ventilator-associated prone group would be in the prone posi-
teral nutrition, inhaled nitric oxide, or pneumonia incidence was significantly tion for at least 8 hours per day until their
almitrine were similar in both groups lower in prone group (Table 3). conditions had improved, which had
(TABLE 2). The mean (SD) time be- In the prone group, PaO2/FIO2 ratio been defined by predetermined criteria.
tween ICU admission and randomiza- was significantly higher (Table 3), but In our study, prone positioning was
tion was 54.8 (72.7) hours for the su- VT, PEEP, and FIO2 readings were sig- applied for a mean (SD) of 8.6 (6.6) hours
pine group vs 58.6 (84.3) hours for the nificantly lower than those in the su- per day for 4.1 (4.7) days. Nevertheless,
prone group (P=.23) and length of ICU pine group (TABLE 4). The PaCO2 and the prone position regimen was not
stay 24.5 (21.9) and 26.6 (29.6) days pH levels were not significantly differ- adequate because 25% of patients were
(P=.35), respectively. The mean (SD) de- ent over time between groups (Table 4). so placed for fewer than 8 hours. Fourth,
lay between intubation and initiating the Selective intubation, endotracheal whereas eligibility of patients other than
first prone position session was 50.8 tube obstruction, and incidences of those with ARDS or ALI could be seen
(74.1) hours and between randomiza- pressure sores were significantly greater as a limitation, our basic question was
tion and the first prone position session in prone group than in the supine group “Should we systematically try prone posi-
was 4.3 (4.6) hours. (TABLE 5). Incidence of other adverse tioning in hypoxemic patients?” Hence,
events was not significantly different. the protocol was designed to directly
Prone Position The mean (SD) reduction in organ dys- address our research question.
Patients were in the prone position for function was 0.36 (0.95) per day in the Our findings confirm the results of the
a median of 4.0 (interquartile range, 2.0- supine group and by 0.34 (1.01) per day trial by Gattinoni et al13 in which 304
6.0) days. During the first week after in the prone group (P=.30). ARF patients, mostly with ARDS, re-
randomization, the median amount of The 28-day mortality (P = .73), 90- ceived no benefit from prone position
time patients were in the prone posi- day mortality (P=.79), VAP incidence placement in terms of survival and du-
tion was 8.0 (interquartile range, 7.7- (P=.42), and successful extubation rate ration of mechanical ventilation. These
9.8) hours per day and 0.0 hours per (P = .84) did not differ among centers. investigators had planned to use prone
day for the 81 patients who had crossed positioning for at least 6 hours per day
over to the prone group (P⬍.001). COMMENT for 10 days. In fact, patients were in the
The main findings of this concealed, un- prone position for a mean (SD) of 7.0
Mortality blinded, multicenter, randomized trial (1.8) hours per day, and 41 (27%) of 152
Crude 28-day mortality rates were 31.5% of hypoxemic ARF patients showed that patients in the prone group were so
in the supine group and 32.4% in the early prone positioning did not re- placed for fewer hours than were ex-
2384 JAMA, November 17, 2004—Vol 292, No. 19 (Reprinted) ©2004 American Medical Association. All rights reserved.
0.8
drainage effect, reduction of bacterial 0.7
translocation in experimental ALI,31 and
0.6
reduction of VILI.11 In our study, VT and
FIO2 were slightly lower in the prone 0.5
tality in trials studying the effects of prone tients with hypoxemic ARF demon- sions and timing of the intervention;
positioning on either patients who are strated improved oxygenation and a prone positioning in combination with
severely hypoxemic13 or unselected mild lower incidence of VAP but signifi- optimal VT and PEEP; and different tar-
hypoxemic patients. cant harmful effects and no mortality get populations, evaluating outcomes
In conclusion, the results of this mul- benefit. Further prone positioning re- such as major morbidities, patient
ticenter trial of prone positioning in pa- search should address the treatment ses- safety, and mortality.
Table 4. Time Course of Arterial Carbon Dioxide, Arterial pH, and Ventilatory Settings During the First Week of Mechanical Ventilation
Mean (SD)
2386 JAMA, November 17, 2004—Vol 292, No. 19 (Reprinted) ©2004 American Medical Association. All rights reserved.
Author Affiliations: Service de Réanimation Médicale, de Réanimation Médicale, hôpital de la Croix-Rousse, 10. Nakos G, Tsangaris I, Kostanti E, et al. Effect of
Hôpital De La Croix-Rousse, Lyon (Drs Guerin, Gail- Lyon (M. Badet, C. Guérin, B. Langevin, P. Noel, F. Phi- the prone position on patients with hydrostatic pul-
lard, and Lemasson); C-Clin Sud-Est, Centre Hospi- lit); Service de Réanimation Médicale, Hôpital Edouard- monary edema compared with patients with acute res-
talier Lyon-Sud, Pierre Bénite (Dr Ayzac); Service Herriot, Lyon (L. Argaud, O. Martin, I. Mohamedi, D. piratory distress syndrome and pulmonary fibrosis. Am
d’hygiène et d’épidémiologie, Centre Hospitalier Lyon- Robert); Service de Réanimation Chirugicale, Hôpital J Respir Crit Care Med. 2000;161:360-368.
Sud, Pierre Bénite (Dr Girard); Service de Réanimation de la Croix-Rousse, Lyon (S. Duperret, J. P. Viale); Ser- 11. Broccard A, Shapiro RS, Schmitz LL, Adams AB,
Polyvalente, Roanne (Dr Beuret); Service de Réanima- vice de Réanimation Médicale, center hospitalier Saint Nahum A, Marini JJ. Prone positioning attenuates and
tion, Hôpital D’instruction Des Armées, Toulon (Dr Joseph, Lyon (P. Dorne, M. Manchon, C. Pomier, S. redistributes ventilator-induced lung injury in dogs. Crit
Palmier); Service de Réanimation Polyvalente, Chalon- Rosselli); Service de Réanimation, Hôpital d’instruction Care Med. 2000;28:295-303.
Sur-Saône (Dr Viet Le); Service de Réanimation Poly- des armées, Lyon (E. Combourieu, J. Escarment, R. G. 12. Slutsky AS, Tremblay LN. Multiple system organ
valente, Annecy (Dr Sirodot); Service de Réanimation Patrigeon, J. L. Soubirou); Service de Réanimation Poly- failure: is mechanical ventilation a contributing factor?
Médicale, Centre Hospitalier Saint Joseph, Lyon (Dr Ros- valente, Mâcon (M. Clavier, D. Debatty, J. Latrasse); Am J Respir Crit Care Med. 1998;157:1721-1725.
selli); Service de Réanimation Médicale, Centre Hospi- Service de Réanimation Médicale, hôpital Sainte Mar- 13. Gattinoni L, Tognoni G, Pesenti A, et al. Effect of
talier Lyon-Sud, Lyon (Dr Cadiergue); Service de Ré- guerite, Marseille (J. M. Forel, L. Papazian, J. M. Sainty); prone positioning on the survival of patients with acute
animation Médicale, Hôpital Sainte Marguerite, Marseille Service de Réanimation Médicale, Centre Hospitalier respiratory failure. N Engl J Med. 2001;345:568-573.
(Dr Sainty); Service de Réanimation Polyvalente, Cham- Lyon-Sud, Pierre Bénite (J. Bohé, V. Cadiergue, D. 14. Mancebo J, Rialp G, Fernandez R, et al. Random-
béry (Dr Barbe); Service de Réanimation, Hôpital Jacques, G. Fournier); Service de Réanimation Médi- ized multicenter trial in ARDS: supine versus prone
D’instruction Des Armées, Lyon (Dr Combourieu); Ser- cale, CHU, Poitiers (R. Robert, J. Rouffineau); Service position. Intensive Care Med. 2003;29:S64.
vice de Réanimation Polyvalente, Mâcon (Dr De- de Réanimation Polyvalente, Roanne (M. P. Carton, J. 15. Roupie E, Lepage E, Wysocki M, et al. Preva-
batty); Service de Réanimation Médicale, CHU, Poit- C. Ducreux, M. Kaaki, Nourdine K); Service de Réani- lence, etiologies and outcome of the acute respira-
iers (Dr Rouffineau); Service de Réanimation, Clinique mation, Clinique Mutualiste, Saint-Etienne (E. Ezinge- tory distress syndrome among hypoxemic ventilated
Mutualiste, Saint-Etienne (Dr Ezingeard); Service de Ré- ard, B. Stimmesse); Service de Réanimation, Hôpital patients: SRLF Collaborative Group on Mechanical
animation, Lons-Le-Saunier (Dr Millet); Service de Ré- d’instruction des armées, Toulon (E. Cantais, E. Kaiser, Ventilation. Intensive Care Med. 1999;25:920-929.
animation Chirurgicale, CHU Gabriel Montpied, Cler- B. Palmier, J. F. Quinot, L. Salinier). 16. Gaussorgues P, Chazot C, Vedrinne C, Piperno
mont-Ferrand (Dr Guelon); Service de Réanimation Funding/Support: This work was promoted by the Hos- D, Boyer F, Robert D. Amélioration des pneumopa-
Polyvalente, Aix-En-Provence (Dr Rodriguez); Service pices Civils de Lyon (HCL) and supported by grants thies diffuses par la ventilation en décubitus ventral.
de Réanimation Médicale, Hôpital Edouard-Herriot, Lyon HCL-PHRC 97.053 and HCL-PHRC 97.00.053 from Presse Med. 1987;16:1200.
(Dr Martin); Service de Réanimation Médicale, CHU, the Ministère de la Santé of France (Programme Hos- 17. Beuret P, Carton MJ, Nourdine K, Kaaki M, Tra-
Brest (Dr Renault); Service de Réanimation Polyva- pitalier de Recherche Clinique) and the Hospices Civils moni G, Ducreux JC. Prone position as prevention of
lente, Briançon (Dr Sibille); and Service de Réanima- de Lyon (Appel d’Offres de Recherche Clinique). The lung injury in comatose patients. Intensive Care Med.
tion Polyvalente, Fréjus (Dr Kaidomar), France. project protocol was recorded at the Direction Générale 2002;28:564-569.
Author Contributions: Dr Guerin had full access to all de la Santé (Ministère de l’emploi et de la solidarité) 18. Bone RC, Balk RA, Cerra FB, et al. Definitions for
of the data in the study and takes responsibility for of France and identified as No. DGS 980279. sepsis and organ failure and guidelines for the use of
the integrity of the data and the accuracy of the data Role of the Sponsors: The funding agencies were not innovative therapies in sepsis. Chest. 1992;101:1644-
analysis. involved in the design and conduct of the study; the 1655.
Study concept and design: Guerin, Gaillard, Ayzac, collection, management, analysis, and interpretation 19. Fagon JY, Chastre J, Novara A, Medioni P, Gib-
Girard. of the data; or the preparation, review, or approval ert C. Characterization of intensive care unit patients
Acquisition of data: Guerin, Gaillard, Lemasson, Ayzac, of the manuscript. using a model based on the presence or absence of
Beuret, Palmier, Viet Le, Sirodot, Rosselli, Cadiergue, Acknowledgment: We thank Isabelle Sabaud for re- organ dysfunctions and/or infection: the ODIN model.
Sainty, Barbe, Combourieu, Debatty, Rouffineau, Ez- view of the language. Intensive Care Med. 1993;19:137-144.
ingeard, Millet, Guelon, Rodriguez, Martin, Renault, 20. Bernard GR, Artigas A, Brigham KL, et al. The
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