Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458926
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2007-04-09
Brief Title:
Enhancing Utilization of Non-Invasive Positive Pressure Ventilation in Critical Care
Sponsor:
Tufts Medical Center
Organization:
Tufts Medical Center
Study Overview
Official Title:
Enhancing Utilization of Non-Invasive Positive Pressure Ventilation in Critical Care
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 56 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 NPPVs 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 initiationsmonth 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 educationin-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 patients 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 1516 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
RiskBenefit 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 3551931-1935
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 3562126-2132
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 344481-487
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 respiratory failure in patients with severe community-acquired pneumonia Am J Respir Crit Care Med 1999 160 1585-1591
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 intubation Crit Care Med 1994 22 1584-1590
13 Bach JR Brougher P Hess DR et al Consensus statement Noninvasive positive pressure ventilation Respir Care 1997 42 365-369 6 6
14 Carlucci A Richard J-C Wysocki M Lepage E Brochard L Noninvasive versus conventional mechanical ventilation and epidemiological survey Am J Respir Crit Care Med 2001 163874-880
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 noninvasive positive pressure ventilation for acute respiratory failure Chest 2003 12362062-73
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 56 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 NPPVs 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 initiationsmonth 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 educationin-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 patients 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 1516 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
RiskBenefit 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 3551931-1935
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 3562126-2132
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 344481-487
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 respiratory failure in patients with severe community-acquired pneumonia Am J Respir Crit Care Med 1999 160 1585-1591
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 intubation Crit Care Med 1994 22 1584-1590
13 Bach JR Brougher P Hess DR et al Consensus statement Noninvasive positive pressure ventilation Respir Care 1997 42 365-369 6 6
14 Carlucci A Richard J-C Wysocki M Lepage E Brochard L Noninvasive versus conventional mechanical ventilation and epidemiological survey Am J Respir Crit Care Med 2001 163874-880
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 noninvasive positive pressure ventilation for acute respiratory failure Chest 2003 12362062-73
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None