Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00458926 |
| Other study ID # |
6742 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 2003 |
| Est. completion date |
December 2009 |
Study information
| Verified date |
February 2023 |
| Source |
Tufts Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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
Description:
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
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