Enhancing Utilization of Non-Invasive Positive Pressure Ventilation in Critical Care
Enhancing Utilization of Non-Invasive Positive Pressure Ventilation in Critical Care
Non-invasive positive pressure ventilation (NIV) refers to the provision of mechanical
 ventilation without an artificial airway (for example, an endotracheal tube). Over the past
 decade, evidence from randomized control trials has accumulated to demonstrate effectiveness
 of the technique in avoiding intubation, reducing complications associated with intubation,
 shortening ICU and hospital lengths of stay, and reducing mortality rates in selected
 patients with acute respiratory failure. However, NIV is still underutilized at many medical
 centers. The purposes of this project will be to acquire information related to NIV use, to
 identify reasons for underutilization, to implement interventions that encourage more
 appropriate use of NIV, and to evaluate the effectiveness of the interventions. Reliable
 information on NIV use as well as analysis of reasons for underutilization will provide
 insight into ways of enhancing NIV use. We will determine utilization rate, technology used,
 patient diagnoses, duration of ventilator use and hospital stay, and success rates as
 recorded on case report forms (CRFs). After completing the survey, we will provide an
 educational program to randomly selected institutions (one-half of the total) aimed at
 increasing the knowledge and skill of physicians, nurses, and therapists regarding use and
 implementation of NIV. Data will be gathered for a second round with the same data-gathering
 instruments used during
Project Focus The focus of this project is to improve the ventilatory management of patients
 with acute respiratory failure in the critical care setting by enhancing the use of
 non-invasive ventilation, a goal that should lead to improved outcomes and efficiency of
 care. Within the framework of the funding agency, the Chest Foundation, this proposal aims to
 promote the use of alternative therapies in treating patients with critical illness, educate
 practitioners, and disseminate new knowledge regarding the therapy.

 Background Non-invasive positive pressure ventilation (NPPV) provides mechanical ventilation
 without the need for airway invasion through the use of either nasal or oronasal masks
 (covering both the nose and mouth) attached to positive pressure ventilators. Published
 evidence from randomized control trials has demonstrated the effectiveness of the technique
 in avoiding intubation, reducing complications associated with intubation, shortening ICU and
 hospital lengths of stay, and reducing mortality rates in selected patients with acute
 respiratory failure. Randomized trials have demonstrated effectiveness in patients with acute
 exacerbations of COPD (1-3), cardiogenic pulmonary edema (4), immunocompromised patients with
 hypoxemic respiratory failure (5,6), facilitating the weaning process in patients ventilated
 invasively (7), and in patients who develop respiratory insufficiency after lung resection
 (8). In addition, evidence that is not quite as strong supports the use of NPPV in patients
 with acute asthma (9), cystic fibrosis (10), community-acquired pneumonia if there is
 underlying COPD (11), and patients with a do-not-intubate status (12).

 Based on this evidence, consensus groups have recommended the use of NPPV in treating
 patients with COPD exacerbations and for selected patients with other diagnoses (13).
 However, NPPV is still underutilized at many medical centers throughout the world (14) and it
 is fair to presume that many patients are being deprived of NPPV's advantages and that ICU
 resources are being wasted. Similar surveys have not been performed in the US, and my firm
 impression from polling audiences when I speak on this subject is that a similar proportion
 of US centers are not using NPPV. The purposes of this project are to acquire this
 information in a US setting, to identify reasons for underutilization, to implement
 interventions that encourage more appropriate use of NPPV, and then to evaluate the
 effectiveness of the intervention.

 The successful implementation of this project may have a major impact on the practice of
 critical care medicine. Reliable information on utilization of NPPV as well as analysis of
 reasons for underutilization will provide insight into ways of enhancing utilization.
 Educational programs designed to enhance practitioners' skills in implementing NPPV should
 lead to greater utilization and improved success rates. Optimal utilization of NPPV should
 lead to improved outcomes for patients with respiratory failure, more rational use of
 resources, and lower ICU costs for our health care system.

 Project A. Major Hypothesis: An educational intervention will increase utilization and
 success rates of NPPV in hospitals that currently underutilizing it.

 B. General Outline 1. Site selection

 1. Select 8 sites that use NPPV in < 10% of patients receiving mechanical ventilatory
 assistance, based on a survey mailed to acute care hospitals in Massachusetts and Rhode
 Island during 2002. Sites will be selected based on: (i) willingness to participate (as
 per request of Respiratory Therapy director), (ii) > 30 mechanical ventilation
 initiations/month as reported in the survey, and (iii) n more than 90 minute drive from
 Boston.

 2. Perform prospective evaluation of use of NPPV that will determine rate of utilization,
 technology used, patient diagnoses, duration of ventilator use and hospital stay, and
 success rates as recorded on case report forms.

 3. Intervention (or control) phase. After completion of survey, provide
 education/in-servicing program to 5 randomly selected sites aimed at increasing
 knowledge and skill of physicians, nurses, and respiratory therapists in the use and
 implementation of NPPV.

 C. Evaluation phase

 1. Re-survey targeted institutions with regard to use of NPPV and patient outcomes.

 Methods A. Prospective Survey at 8 Selected Institutions Underutilize NPPV

 1. Random selection will be performed using computer-generated number sequence,
 selecting sites based on alphabetical listing.

 2. Data will be gathered on CRFs that will document utilization of mechanical
 ventilation; number of NPPV starts; patient diagnoses; date, time, and location of
 NPPV use; equipment and settings used to ventilate; success rate of NPPV; duration
 of NPPV use; and eventual patient outcomes.

 3. Data collectors from Tufts or respiratory therapists at each site will initiate CRF
 use. Personal health information will be de-identified by using study code numbers.
 The patient medical record number cross-referenced to the patient code will be kept
 on a separate list kept in a locked area, so that the patient's medical record can
 be located to retrieve missing data and recorded data can be verified.

 B. Education and In-Servicing

 Educational and in-servicing sessions will be provided to randomly selected
 underutilizing sites and will review guidelines provided in the literature by the PI
 (15,16) as well as other investigators (17). Grand rounds and other lecture venues for
 the physicians working in emergency and critical care settings will describe the skills
 needed to select patients who will benefit from the use of NPPV. Workshops for
 respiratory therapists will review patient selection, proper use of equipment, and
 monitoring and weaning techniques. In-servicing sessions for emergency and critical care
 nurses will review the rationale behind NPPV use and how to monitor patients who are
 placed on NPPV. At control sites, no intervention will be undertaken prior to the second
 data survey.

 C. Evaluation Phase

 Mechanical ventilation and NPPV utilization will be tracked with the same data gathering
 instruments used during the initial phase. Initial and follow-up data gathering will be
 staggered. The follow-up evaluation in the control group will be timed to correspond
 with follow-up in institutions receiving the intervention.

 Main Outcome Variables

 1. Rate of NPPV utilization.

 2. NPPV success.

 3. Compliance with guidelines.

 Analysis The main outcome variables will be analyzed as categorical variables by chi
 square analysis or the Mann-Whitney test as appropriate. Initial data will be compared
 to follow-up data obtained during the follow-up phase using paired t-tests, Mann-Whitney
 tests, as appropriate. Comparisons between the intervention and control groups at
 baseline and follow-up will be made using unpaired t-tests or chi square analyses as
 appropriate. Because randomization is by site, data will be clustered by institution,
 although we will be limited by resources as to the number of sites in this study. Using
 linear regression analysis, we will be able to determine risk ratios for failure for a
 number of initial characteristics, including diagnosis, vital signs, blood gases,
 presence of cough and airway secretions, body mass index, sedation, kind of equipment
 used, in-hospital locations for NPPV implementation, and other characteristics.

 Anticipated Results We anticipate that results from the sites selected to receive the
 training intervention and control sites will be similar at baseline and that the
 intervention will increase utilization and success rates of NPPV compared to baseline.
 Utilization and training rates also may increase at control sites, because of an
 increased trend toward NPPV use in acute care settings. However, the important
 comparison will be between the intervention and control sites at follow-up. If
 intervention is effective, NPPV utilization and success rates will be increased at
 intervention sites compared to controls. Other key differences may be detectable, such
 as shorter ICU lengths of stay and reduced mortality rates among respiratory failure
 patients treated at the intervention sites.

 Risk/Benefit Analysis This is a prospective observational trial that involves no patient
 intervention. Patients are to be managed by their primary caregivers, and guidelines are
 provided to randomly selected institutions. These guidelines, derived from standards in
 the literature (15-17) aim to improve the outcomes of patients receiving NPPV. Because
 the trial is observational, involves no direct patient intervention, and poses
 essentially no direct risk to patients, we are requesting waiver of consent. The patient
 data that we are collecting aims to track standard clinical information and will be
 de-identified.

 Protection of Personal Health Information CRFs will be de-identified for the purposes of
 the study. CRFs will be kept in a locked office. A cross-referenced sheet containing
 medical record numbers and patient code numbers will be kept in a locked file until
 missing data are retrieved and data verified using chart review. Once the data set is
 complete and validated, the cross-referenced sheet will be shredded and discarded.

 Limitations, Potential Problems, and Strengths One limitation is that optimal
 utilization rates for NPPV in the acute care setting have not been established. In
 addition, overutilization (use in inappropriate candidates) at some centers is also a
 concern, as noted in the European survey (14). Although this project will focus on
 underutilization of NPPV, we will able to track evidence of inappropriate applications.
 Another concern is that there can be no blinding as to study condition at individual
 centers, introducing the possibility of center-based bias. Randomization of intervention
 and control centers should minimize this concern.

 The study also has several strengths. Compared to the European ICU survey that only
 included selected centers that had volunteered to serve in a consortium, this project
 will obtain information on NPPV use in all acute care centers in a geographic region,
 giving a more accurate glimpse of actual usage rates. In addition, the survey will
 provide information on reasons for under-utilization and the inclusion of an
 intervention will shed light on the effectiveness of strategies to enhance utilization.
 These results can then be applied to achieve more appropriate use of NPPV. The study
 might also provide insight into techniques that could also be applied to other critical
 care practices, such as use of particular ventilator settings for invasive mechanical
 ventilation, or use of certain pharmacological agents.

 References

 1. Kramer N, Meyer TJ, Meharg J et al: Randomized, prospective trial of noninvasive
 positive pressure ventilation in acute respiratory failure. Am J Respir Crit Care
 Med 1995; 151: 1799-1806.

 2. Brochard L, Mancebo J, Wysocki M et al: Noninvasive ventilation for acute
 exacerbations of chronic obstructive pulmonary disease. N Engl J Med 1995; 333:
 817-822.

 3. Plant PK, Owen JL, and Elliott MW: Early use of noninvasive ventilation for acute
 exacerbations of chronic obstructive pulmonary disease on general respiratory
 wards: a multicenter randomized controlled trial. Lancet 2000; 355:1931-1935.

 4. Masip J, Betbese AJ, Paez J, Vecilla F, Canizares R, Padro J, Paz Marco A, Otero J,
 Bllus J: Non-invasive pressure support ventilation versus conventional oxygen
 therapy in acute cardiogenic pulmonary oedema; a randomized study. Lancet 2000;
 356:2126-2132.

 5. Antonelli M, Conti G, Bufi M, Costa MG, Lappa A, Rocco M, Gasparetto M, Meduri GU:
 Noninvasive ventilation for treatment of acute respiratory failure in patients
 undergoing solid organ transplantation. JAMA 2000, 283: 235-241.

 6. Hilbert G, Gruson D, Vargas F, Valentino R, Gbikpi-Benissan G, Dupon M, Reiffers J,
 and Cardinaud JP. Noninvasive ventilation in Immunosuppressed patients with
 pulmonary infiltrates, and acute respiratory failure. N Engl J Med 2001;
 344:481-487.

 7. Nava S, Ambrosino N, Clini E, Prato M, Orlando G, et al. Non-invasive mechanical
 ventilation in the weaning of patients with respiratory failure due to chronic
 obstructive pulmonary disease: a randomized study. Ann Intern Med 1998; 128:
 721-728.

 8. Auriant I, Jallot A, Herve P, et al. Noninvasive ventilation reduces mortality in
 acute respiratory failure following lung resection. Am J Respir Crit Care Med 2001;
 164: 1231-1235.

 9. Meduri GU, Cook TR, Turner RE, Cohen M and Leeper KV. Noninvasive positive pressure
 ventilation in status asthmaticus. Chest 1996; 110: 767-774

 10. Hodson ME, Madden BP, Steven MH et al. Noninvasive mechanical ventilation for
 cystic fibrosis patients - a potential bridge to transplantation. Eur Respir J
 1991; 4: 524-527.

 11. Confalonieri M, Potena A, Carbone G, Della Porta R, Tolley EA, and Meduri GU. Acute
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 12. Meduri GU, Fox RC, Abou-Shala N, et al. Noninvasive mechanical ventilation via face
 mask in patients with acute respiratory failure who refused endotracheal
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 13. Bach JR, Brougher P, Hess DR et al. Consensus statement: Noninvasive positive
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 conventional mechanical ventilation: and epidemiological survey. Am J Respir Crit
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 15. Criner GJ, Kreimer DT, Tomaselli M, Pierson W, and Evans D. Financial implications
 of noninvasive positive pressure ventilation (NPPV). Chest 1995; 108: 475-481.

 16. Hill NS, ed. Noninvasive Positive Pressure Ventilation; Principles and
 Applications. Futura, Armonk, NY, 2001.

 17. Sinuff T, Cook DJ, Randall J, Allen CJ. Evaluation of a practice guideline for
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Inclusion Criteria:

 -  Starting on mechanical ventilation (including: invasive, noninvasive, CPAP or BiPAP
 for purpose of treatment of respiratory failure)

 -  18 years of age or older

 Exclusion Criteria:

 -  Use of home mechanical ventilation, including nocturnal ventilation, continuous
 mechanical ventilation,BiPAP.

 -  Continuous use of CPAP or BiPAP for treatment of obstructive sleep apnea.

 -  Placed on mechanical ventilation for purposes of surgical anesthesia or use of
 anesthesia for a diagnostic procedure.

 -  Patient has tracheostomy or was intubated endotracheally prior to admission.