ACUTE AND CHRONIC CARE DURING MECHANICAL VENTILATION

Release Date:  October 8, 1998

PA NUMBER: PA-99-003

P.T.

National Institute of Nursing Research

PURPOSE

The National Institute of Nursing Research (NINR) seeks research applications for
investigator-initiated research to improve the clinical management and care
delivery of patients who require mechanical ventilation.  For the purpose of this
Program Announcement (PA), the time course of mechanical ventilation is defined
as beginning with endotracheal or tracheal tube intubation, maintenance of full
and/or partial ventilatory support, discontinuation of mechanical ventilation via
weaning techniques, and concluding with care of patients who require chronic
mechanical ventilation.  Two different, but related, types of basic science
and/or clinical research on acute and/or chronic mechanical ventilation are
encouraged:  (1) studies examining the effects of physiological, environmental
and/or psychological approaches to facilitate the care of patients during any
phase of mechanical ventilation, and  (2) studies directed toward examining the
physical and psychological ramifications of technology dependency on patients and
their families/significant others.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This PA, Acute and Long-Term Care During
Mechanical Ventilation, is related to the priority areas of chronic disabling
diseases and people with disabilities.  Potential applicants may obtain a copy
of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of the
Federal government.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) research project grant
(R01) award mechanism.  Responsibility for the planning, direction, and execution
of the proposed project will be solely that of the applicant. The total project
period for an application submitted in response to this PA may not exceed five
years.

Applicants planning to submit an investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended/revised version of
the preceding grant application types requesting $500,000 or more in direct costs
for any year are advised that he or she must contact Institute or Center (IC)
program staff (see INQUIRIES, below) before submitting the application, i.e., as
plans for the study are being developed. Furthermore, the applicant must obtain
agreement from IC staff that the IC will accept the application for consideration
for award. Finally, the applicant must identify, in a cover letter sent with the
application, the staff member and Institute or Center who agreed to accept
assignment of the application. This policy requires an applicant to obtain
agreement for acceptance of both any such application and any subsequent
amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998
(http://www.nih.gov/grants/guide/notice-files/not98-030.html).

RESEARCH OBJECTIVES

Background

The Nursing Assembly of the American Thoracic Society and the American
Association for Critical Care Nurses have established research priorities for
respiratory nursing.  Both reports describe the need to conduct research in
mechanical ventilation.  Research areas identified by these two groups include
optimum ways to deliver patient care during mechanical ventilatory support;
ethical issues related to initiation, maintenance and withdrawal of life support
technology; emotional support and communication during mechanical ventilation;
methods of optimally managing the artificial airway; impact of care on family
dynamics; and decision-making regarding withdrawal of ventilatory support. 
Research is also needed to describe and intervene with care-giving resources,
family functioning and quality of life for patients on mechanical ventilation
particularly chronically ill children and adults being maintained on home
ventilators; optimum methods and techniques to deliver nursing care while
critically ill patients receive mechanical ventilation; and determine optimal
measures for promoting recovery as patients move through levels of care in acute,
intermediate, and long-term care, e.g., acute care hospitals, subacute
facilities, rehabilitation hospitals, long-term acute care hospitals, and skilled
nursing facilities.  This PA covers a wide range of topics relevant to clinical
management and clinical problem solving issues for patients who require
mechanical ventilation.

Mechanical ventilation has prolonged the lives of many patients whose respiratory
function has been compromised by drugs, disease, trauma, surgical procedures and
other conditions that do not permit adequate breathing without assistance. These
critically ill and chronically ill patients who require mechanical ventilation
for survival are a diverse population and include, but are not limited to preterm
infants in neonatal intensive care units; adolescents who are ventilator
dependent as a result of spinal cord injury or genetic conditions; and adults who
require mechanical ventilatory because of postoperative complications,
exacerbations of chronic lung diseases such as emphysema, and diagnoses of acute
respiratory failure and trauma.  Tested approaches to insure appropriate
decisions before patients are intubated and placed on mechanical ventilation,
methods to facilitate weaning from mechanical ventilation, techniques to modify
discomfort during mechanical ventilation, and ways to enhance quality of life for
those patients who require mechanical ventilation as a way of life have not been
scientifically established for this diverse population of patients with uniquely
different health care needs. Interventions to prevent secondary complications of
mechanical ventilators and artificial airways such as inflammation and infection
of the airways, pneumothorax and injury to the lung, and decreases in blood
pressure and cardiac function require further research.  In addition, nursing
care to complement pharmacologic analgesics, sedatives and muscle relaxants for
patients who find mechanical ventilation and artificial airways physically and
psychologically intolerable require investigation.

For some patients who require mechanical ventilation, the return to spontaneous
breathing is uncomplicated and is completed by following clinical protocols for
discontinuing ventilator support.  However, because transitions in mechanical
ventilation are poorly tolerated in other patients, ventilator support must be
removed more gradually and requires individual modulation and careful monitoring
of ventilator controls based upon metabolic, pulmonary, cardiovascular, and
neurological parameters.  In addition, there are distinct groups of patients who
are unable to be weaned from mechanical ventilation and who become dependent upon
this technology as a chronic form of life support.  Patients who require long
term mechanical ventilation and those patients who are ventilator dependent may
possess a unique blend of medical, physiological, and psychological disorders,
which can thwart attempts to discontinue mechanical ventilation.  Research on
care givers of this population is needed as they become exhausted from the
physical, emotional, and financial drain of providing extended care.

There are patients who have difficulty weaning from mechanical ventilation
despite parameters that appear to attest to their physiological and psychological
readiness to discontinue mechanical ventilation.  The literature reports results
of different clinical trials where identical weaning methods in similar patient
populations concluded differences in the effectiveness of the weaning mode used. 
Research is needed to establish ways to optimize physiological, environmental,
and psychological parameters and identify how these interventions, in combination
with clinician interventions and support, can facilitate the process of
discontinuation from mechanical ventilation.

Interdisciplinary studies are also needed examining ethical and cost-related
issues in conjunction with clinical research questions.  Studies focusing on the
unique needs of infants, children and elders are strongly encouraged.

Research Objectives and Scope

Examples of topics for each type of study that would be responsive to this PA are
provided below.  Applications can address, but are not limited to, these
examples.

(1) studies examining the effects of physiological, environmental and/or
psychological approaches to facilitate the care of patients during any phase of
mechanical ventilation; examples include:

o The identification and testing of ways to encourage cognitive, affective and
psychomotor growth and development during the time course of mechanical
ventilation, especially for infants, children and adolescents.

o The identification of optimum ways to deliver nursing care based upon symptom
assessment and management to severely critically ill patients during mechanical
ventilation.  (e.g., patients with laryngeal and tracheal damage,
gastrointestinal bleeding, infection, congestive heart failure and
bronchopulmonary dysplasia in infants).

o The identification of valid and reliable noninvasive techniques compared with
traditional methods to assess pulmonary function (e.g., arterial blood gases,
mixed venous oxygen saturation, pulmonary artery pressures, transcutaneous
arterial oxygen, pulse oximetry, and end-tidal carbon dioxide).  Special
attention to the iatrogenic complications of these noninvasive techniques and
their appropriateness during the transport of critically ill patients should be
considered.

o The identification of effective modes of ventilation and oxygenation during
ground and air transport in critically ill mechanically ventilated patients,
especially neonates.

o The identification of biological/genetic markers that may be used during
mechanical ventilation (e.g., incorporated in the decision making process of
intubation and/or used to complement the weaning process).

o The elucidation of how the neurologic, endocrine, cardiovascular, and immune
systems can be modulated to effect the weaning process.

o The identification of valid and reliable clinical cues complementing standard
criteria indicating the need for endotracheal suctioning.

(2) studies directed toward examining the physical and psychological effects of
technology dependency on patients and their families/significant others.

o  The development and testing of  behavioral interventions to promote
independence in completing activities of daily living for the chronically ill
requiring mechanical ventilation.

o The development and testing of unique interventions in various settings for
reaching patients on mechanical ventilation and their care providers in order to
promote independence (e.g., the Internet, computer-delivered programs).

o The identification of the effects of exercise, dietary nutrients or supplements
for persons who receive mechanical ventilation, particularly in those patients
who receive mechanical ventilation as a chronic form of life support.

o The identification of interventions to promote emotional support and
communication in the mechanically ventilated patient, particularly for children
and their families.

o The identification of interventions to enhance physical, psychomotor, affective
and cognitive development in infants, children and adolescents who require long-
term and chronic mechanical ventilatory support.

o The effectiveness of behavioral and technological interventions in individuals
with high risk versus those with average risk of becoming dependent on mechanical
ventilation as a way of life (e.g., by informing participants of their risk
status).

Although not a formal sponsor of this program announcement, the National Heart
Lung and Blood Institute (NHLBI) has an interest in research in this area. 
Applications submitted in response to this Program Announcement will be assigned
on the basis of established PHS referral guidelines.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification is provided that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research.  This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No.
11, March 18, 1994 available on the web at the following URL address: 
http://www.nih.gov/grants/guide/notice-files/not98-024.html.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them.  This
policy applies to all initial (Type 1) applications submitted for receipt dates
after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
http://www.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 5/95) is to be used in applying
for these grants. These forms are available at most institutional offices of
sponsored research and from the Division of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/710-0267, email: .  The
title and number of the program announcement must be typed in Section 2 on the
face page of the application.

Submit a signed, typewritten original of the application, including the
Checklist, and five signed, photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral
guidelines.  Applications that are complete will be evaluated for scientific and
technical merit by an appropriate peer review group convened in accordance with
the standard NIH peer review procedures.  As part of the initial merit review,
all applications will receive a written critique.  Applications will also undergo
a process in which only those deemed to have the highest scientific merit,
generally the top half of applications under review, will be discussed, assigned
a priority score, and receive a second level review by the appropriate national
advisory council or board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In the
written comments reviewers will be asked to discuss the following aspects of the
application in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals.  Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application.  Note that the application does not need to be
strong in all categories to be judged likely to have major scientific impact and
thus deserve a high priority score.  For example, an investigator may propose to
carry out important work that by its nature is not innovative but is essential
to move a field forward.

(1) Significance
Does this study address an important problem?  If the aims of the application are
achieved, how will scientific knowledge be advanced?  What will be the effect of
these studies on the concepts or methods that drive this field?

(2) Approach
Is the conceptual framework, design, methods, and analyses adequately developed,
well integrated, and appropriate to the aims of the project?  Does the applicant
acknowledge potential problem areas and consider alternative tactics?

(3) Innovation
Does the project employ novel concepts, approaches or methods?  Are the aims
original and innovative?  Does the project challenge existing paradigms or
develop new methodologies or technologies?

(4) Investigator
Is the investigator appropriately trained and well suited to carry out this work? 
Is the work proposed appropriate to the experience level of the Principal
Investigator and other researchers (if any)?

(5) Environment
Does the scientific environment in which the work will be done contribute to the
probability of success?  Do the proposed experiments take advantage of unique
features of the scientific environment or employ useful collaborative
arrangements?  Is there evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their subgroups,
and children as appropriate for the scientific goals of the research. Plans for
the recruitment and retention of subjects will also be evaluated.

o The reasonableness of the proposed budget and duration in relation to the
proposed research.

o The adequacy of the proposed protection for humans, animals or the environment,
to the extent they may be adversely affected by the project proposed in the
application.

The initial review group will also examine the provisions for the protection of
human subjects and the safety of the research environment.

AWARD CRITERIA

Applications will compete for available funds with all other recommended
applications assigned to that Institute. Award criteria that will be used to make
award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities.

INQUIRIES

Inquiries are encouraged.  We welcome the opportunity to clarify any issues or
questions from potential applicants.

Direct inquiries regarding scientific and programmatic issues to:

Hilary D. Sigmon, PhD, RN
Division of Extramural Activities
National Institute of Nursing Research
Building 45, Room 3AN-12
Bethesda, MD 20892-6300
Telephone: (301) 594-5970
FAX: (301) 480-8260
Email: 

Direct inquiries regarding fiscal matters to:

Jeff Carow
Grants Management Officer
National Institute of Nursing Research
Building 45, Room 3AN-12
6300 Center Drive MSC 6301
Bethesda, MD  20892-6301
Telephone:  (301) 594-6869
FAX:  (301) 480-8260
Email:  

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.361.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241
and 285) and administered under PHS grants policies and Federal Regulations 42
CFR 52 and 45 CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products.  In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.

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