Enhancing Utilization of Non-Invasive Positive Pressure Ventilation in Critical Care
|First Received Date ICMJE||April 9, 2007|
|Last Updated Date||May 30, 2012|
|Start Date ICMJE||November 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00458926 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Enhancing Utilization of Non-Invasive Positive Pressure Ventilation in Critical Care|
|Official Title ICMJE||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
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
Patients 18 years of age or older who require mechanical ventilation.
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||800|
|Estimated Completion Date||December 2012|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00458926|
|Other Study ID Numbers ICMJE||6742|
|Has Data Monitoring Committee||No|
|Responsible Party||Tufts Medical Center|
|Study Sponsor ICMJE||Tufts Medical Center|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Tufts Medical Center|
|Verification Date||May 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP