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Noninvasive Ventilation for Treatment of Acute Respiratory Failure in Patients Undergoing Solid Organ Transplantation a Randomized Trial

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Noninvasive Ventilation for Treatment of Acute Respiratory Failure in Patients Undergoing Solid Organ Transplantation a Randomized Trial CARING FOR THE CRITICALLY ILL PATIENT Noninvasive Ventilation for Treatment of Acute Respiratory Failure in Patients Undergoing Solid Organ Transplantation A Randomized Trial Massimo Antonelli, MD Context Noninvasive ventilation (NIV) has been associated with lower rates of en- Giorgio Conti, MD dotracheal intubation in populations of patients with acute respiratory failure. Maurizio Bufi, MD Objective To compare NIV with standard treatment using supplemental oxygen ad- ministration to avoid endotracheal intubation in recipients of solid organ transplanta- Maria Gabriella Costa, MD tion with acute hypoxemic respiratory failure. Angela Lappa, MD Design and Setting Prospective randomized study conducted at a 14-bed, gen- Monica Rocco, MD eral intensive care unit of a university hospital. Alessandro Gasparetto, MD Patients Of 238 patients who underwent solid organ transplantation from Decem- ber 1995 to October 1997, 51 were treated for acute respiratory failure. Of these, 40 Gianfranco Umberto Meduri, MD were eligible and 20 were randomized to each group. Intervention Noninvasive ventilation vs standard treatment with supplemental oxy- N THE PAST 2 DECADES, ADVANCE- gen administration. ments in immunosuppressive strat- egies and major breakthroughs in Main Outcome Measures The need for endotracheal intubation and mechanical surgical and organ preservation ventilation at any time during the study, complications not present on admission, du- ration of ventilatory assistance, length of hospital stay, and intensive care unit mor- Itechniques have transformed organ tality. transplantation into a therapy for an in- creasing population of patients with end- Results The 2 groups were similar at study entry. Within the first hour of treatment, 14 patients (70%) in the NIV group, and 5 patients (25%) in the standard treatment stage organ failure. Although prevent- group improved their ratio of the PaO to the fraction of inspired oxygen (FIO ). Over ing rejection remains the principle focus 2 2 time, a sustained improvement in PaO2 to FIO2 was noted in 12 patients (60%) in the in improving overall survival statistics, NIV group, and in 5 patients (25%) randomized to standard treatment (P = .03). The pulmonary complications following use of NIV was associated with a significant reduction in the rate of endotracheal in- transplantation are responsible for most tubation (20% vs 70%; P = .002), rate of fatal complications (20% vs 50%; P = .05), morbidity and contribute substantially length of stay in the intensive care unit by survivors (mean [SD] days, 5.5 [3] vs 9 [4]; to the mortality associated with vari- P = .03), and intensive care unit mortality (20% vs 50%; P = .05). Hospital mortality ous organ transplantation procedures.1 did not differ. Approximately 5% of patients undergo- Conclusions These results indicate that transplantation programs should consider ing renal, hepatic, cardiac, or pulmonary NIV in the treatment of selected recipients of transplantation with acute respiratory transplantationdeveloppneumoniainthe failure. period after transplantation, which has JAMA. 2000;283:235-241 www.jama.com an associated crude mortality of 37%.1 In patients with acute respiratory failure the need for an invasive artificial air- Author Affiliations are listed at the end of this ar- (ARF), endotracheal intubation is the way.2 In ARF, when noninvasive ven- ticle. Corresponding Author and Reprints: Massimo Antonelli, single most important predisposing fac- tilation (NIV) is effective in avoiding MD, Istituto di Anestesiologia e Rianimazione, Univer- tor for developing nosocomial bacterial endotracheal intubation, the inci- sita` Cattolica del Sacro Cuore, 1 Largo F. Vito, 00168 2 Rome, Italy (e-mail: [email protected]). pneumonia. dence of bacterial pneumonia is ex- Caring for the Critically Ill Patient Section Editor: Noninvasive positive-pressure ven- tremely low.3 Small, uncontrolled stud- Deborah J. Cook, MD, Consulting Editor, JAMA. Advisory Board: David Bihari, MD; Christian Brun- tilation refers to the delivery of as- ies in recipients of lung transplants have Buisson, MD; Timothy Evans, MD; John Heffner, MD; sisted mechanical ventilation without reported that NIV permits ealier extu- Norman Paradis, MD. ©2000 American Medical Association. All rights reserved. JAMA, January 12, 2000—Vol 283, No. 2 235 Downloaded From: https://jamanetwork.com/ on 10/01/2021 NONINVASIVE VENTILATION IN PATIENTS WITH SOLID ORGAN TRANSPLANTS bation after transplantation surgery,4 and neous presence of renal and cardiovas- ume of 8 to 10 mL/kg, a respiratory rate can prevent need for intubation in those cular failures)7; and tracheostomy, fa- of fewer than 25/min, the disappear- with ARF.1,5 Randomized studies of NIV cial deformities, or recent oral, ance of accessory muscle activity (as in solid organ transplant recipients with esophageal, or gastric surgery. The sim- evaluated by palpating the sternoclei- hypoxemic ARF are lacking. plified Acute Physiologic Score was cal- domastoid muscle),9 and patient com- In a previous randomized study we culated on admission to the study.8 fort. Positive end-expiratory pressure demonstrated the efficacy of NIV to To minimize the risk of bias due to was increased in increments of 2 to 3 treat immunocompetent patients with the obvious difficulty of blinding in this cm H2O repeatedly up to 10 cm H2O un- ARF of various origins, comparing NIV study, medical management of the ARF til the FIO2 requirement was 0.6 or less. delivered through a face mask with con- (eg, antibiotic, antiviral, or antifungal Ventilator settings were adjusted based ventional mechanical ventilation de- agents; bronchodilators; diuretics; fre- on continuous oximetry and measure- livered through an endotracheal tube.6 quent respiratory treatments and chest ments of arterial blood gases. Patients We studied solid organ transplant re- physiotherapy), immunosuppressive were not sedated. cipients with hypoxemic ARF and com- therapy (corticosteroids, azathio- Ventilation was standardized accord- pared NIV delivered through a face mask prine, cyclosporine), time of medical in- ing to the protocol of Wysocki et al.10 with standard treatment using oxygen terventions, central venous pressure and During the first 24 hours, ventilation supplementation to avoid endotra- cardiac output monitoring, frequency was continuously maintained until oxy- cheal intubation and decrease duration of blood gases, and other aspects of ICU genation and clinical status improved. of intensive care unit (ICU) stay. support (head of the bed kept el- Subsequently, each patient was evalu- evated at a 45° angle, nutrition, fluid ated daily while breathing supplemen- METHODS administration, and correction of elec- tal oxygen without ventilatory sup- Study Design and Patient Selection trolyte abnormalities) were similar in port for 15 minutes. Noninvasive We enrolled all consecutive adult re- the 2 groups. Both groups were treated ventilation was reduced progressively cipients of solid organ transplants ad- by the same medical and nursing staffs. in accordance with the degree of clini- mitted to the 14-bed general ICU of La Patients assigned to the standard treat- cal improvement and was discontin- Sapienza University Hospital (Rome, ment group received oxygen supple- ued if the patient maintained a respi- Italy) with acute hypoxemic respir- mentation via a Venturi mask starting ratory rate lower than 30/min and a atory failure. Patients enrolled were with an FIO2 equal to or greater than 0.4, PaO2 greater than 75 mm Hg with a FIO2 randomly assigned to receive either and adjusted to achieve a level of arte- of 0.5 without ventilatory support. standard treatment with oxygen supple- rial oxygen saturation (by oximetry) mentation delivered by Venturi mask above 90%. All patients had continu- Endotracheal Intubation or NIV through a face mask. Computer- ous electrocardiographic and arterial Patients who failed standard treat- generated random assignments were oxygen saturation monitoring (Biox ment or NIV underwent endotracheal concealed in sealed envelopes. A hos- 3700, Ohmeda, Boulder, Colo). We intubation with cuffed endotracheal pital ad hoc ethics committee ap- used 2 types of mechanical ventila- tubes (internal diameter of 7.5-8.5 mm) proved the protocol, and all patients or tors: the Puritan Bennett 7200 (Puri- and were mechanically ventilated. Pre- the next of kin gave written informed tan Bennett Co, Overland Park, Kan) determined criteria included failure to consent. and the Servo 900 C Siemens (Sie- maintain a PaO2 above 65 mm Hg with The criteria for eligibility were acute mens Elema, Uppsala, Sweden). an FIO2 equal to or greater than 0.6; de- respiratory distress; a respiratory rate velopment of conditions necessitating greater than 35/min, a ratio of the PaO2 Noninvasive Ventilation endotracheal intubation to protect the to the fraction of inspired oxygen (FIO2) For patients assigned to NIV, the ven- airways (coma or seizure disorders) or (PaO2:FIO2) of less than 200 while the pa- tilator was connected with conven- to manage copious tracheal secre- tient was breathing oxygen through a tional tubing to a clear, full face mask tions, hemodynamic or electrocardio- Venturi mask; and active contraction of with an inflatable soft cushion seal and graphic instability; inability to correct the accessory muscles of respiration or a disposable foam spacer to reduce dead dyspnea; or inability on the part of the paradoxical abdominal motion. space (Gibeck, Upplands, Sweden). The
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