Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142766
Status:
COMPLETED
Last Update Posted:
2015-10-07
First Post:
2005-08-31
Brief Title:
Sedation Management in Pediatric Patients Supported on Mechanical Ventilation
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Sedation Management in Pediatric Patients Supported on Mechanical Ventilation
Status:
COMPLETED
Status Verified Date:
2015-10
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:
The purpose of this two-year project is to pilot test an intervention to change sedation management in pediatric patients supported on mechanical ventilation for acute respiratory failure in the pediatric intensive care unit PICU While ensuring patient comfort is an integral part of pediatric critical care analgesic and sedative use in this patient population is associated with injury specifically comfort medications may depress spontaneous ventilation and prolong the duration of mechanical ventilation Additionally drug tolerance develops over time and may precipitate iatrogenic abstinence syndrome chemical withdrawal when the patient no longer requires sedation Alternatively suboptimal comfort management contributes to the patient not breathing synchronously with the ventilator andor self-removal of breathing tubes
Our group has developed and validated a nurse-implemented sedation algorithm set of specific instructions to guide titration of comfort medications that may optimize patient comfort and reduce the risk of under-medication but this algorithm needs to be evaluated further We hypothesize that pediatric patients managed per sedation protocol will experience fewer days of mechanical ventilation than patients receiving usual care This research has the potential of revolutionizing sedation practices that are driven by and synchronized to patient needs
Our group has developed and validated a nurse-implemented sedation algorithm set of specific instructions to guide titration of comfort medications that may optimize patient comfort and reduce the risk of under-medication but this algorithm needs to be evaluated further We hypothesize that pediatric patients managed per sedation protocol will experience fewer days of mechanical ventilation than patients receiving usual care This research has the potential of revolutionizing sedation practices that are driven by and synchronized to patient needs
Detailed Description:
We propose a two-year project to pilot test and evaluate an intervention to change sedation management in pediatric patients supported on mechanical ventilation for acute respiratory failure in the PICU Rather than seeking an elusive ideal drug this unique nurse-led pilot study focuses on optimizing clinical decision making by a multidisciplinary team education and consensus building b multidisciplinary team identification of the patients trajectory of illness and daily prescribing of a sedation goal c a nurse-implemented sedation algorithm to guide titration of comfort medications anddteam feedback on clinical performance This intervention models the most recent sedation clinical practice guideline published by the Society of Critical Care Medicine and addresses the only potentially manipulable factor influencing extubation failures rates in the Pediatric Intensive Care Unit
The coordinating center Childrens Hospital Boston developed tested and currently uses the sedation algorithm as a standard of care We will pilot the intervention in two separate previously selected PICUs that are matched on size and organization academic affiliation and volume of patients supported on mechanical ventilation One PICU will be randomized to receive early intervention while the other will first serve as a control then will receive a delayed intervention
The study design is a randomized controlled trial with delayed intervention in the control hospital Because the intervention is an educational and organizational change directed at all PICU clinicians the unit of randomization and analysis is the PICU During the start-up phase case report forms will be developed and a consensus meeting with all nurse and physician co-investigators will be conducted The purpose of this consensus meeting will be to review the Childrens Hospital Boston experience with the sedation algorithm and reach agreement on its application in the two PICUs System nuances may impact protocol implementation and will require group discussion and multidisciplinary problem solving
Study design includes baseline assessment of the organizational structure and comfort practices in both units The PICU randomized to early intervention will then undergo training followed by implementation a one-month respite and post-data collection to evaluate the sustainability of the practice change The PICU randomized to delayed intervention will start with pre-data collection then undergo training followed by implementation This design allows multiple comparisons specifically baseline to interventioncontrol pre and post comparisons in both units and sustainability in one unit
Training will be multifaceted and will include all clinicians physicians nurses clinical pharmacists and physicians-in-training involved in the sedation management of intubated mechanically-ventilated patients A multidisciplinary cooperative approach is necessary to assure compliance and successful implementation of protocols Training material will include discipline-specific lectures informal discussions video on sedation and opioid withdrawal scoring bedside booklets and physician order sheets The research team will develop the supporting materials Physician training will focus on sedation and opioid withdrawal scoring identifying the patients trajectory of illness collaborating with nursing in prescribing the daily sedation goal and completion of the standardized order template Nursing content will likewise focus on sedation and opioid withdrawal scoring trajectory analysis and collaboration but also will include practical support on the daily wake-up test and titration of sedatives Prior to the intervention phase all physicians physician-in-training unit-based clinical pharmacist charge nurses and full-time nursing staff will be required to document their understanding of the intervention by completion of a discipline-specific scenario-based self-assessment evaluation Respiratory therapists will also require refresher instruction on extubation readiness testing and general information about sedation assessment and sedation algorithm
During the implementation phase daily multidisciplinary rounds will include identification of the patients trajectory of illness and daily prescription of a sedation goal and b sedation parameters Nurses will titrate the comfort medications as prescribed and perform a daily wake up test in patients during their stable phase who are not awake During the implementation phase a member of the research team will round separately on each patient to monitor for study compliance and offer staff support and re-training as necessary This level of vigilance is necessary to identify aspects of the algorithm that are challenging to clinicians and accurate reporting of protocol deviations requires an evaluation of the context of decision-making This daily check will not continue in the early intervention arm when sustainability is evaluated During the implementation phase all sedation orders will be derived from standardized physician orders This order template will serve two purposes physician education and enhanced compliance with the algorithm
The coordinating center Childrens Hospital Boston developed tested and currently uses the sedation algorithm as a standard of care We will pilot the intervention in two separate previously selected PICUs that are matched on size and organization academic affiliation and volume of patients supported on mechanical ventilation One PICU will be randomized to receive early intervention while the other will first serve as a control then will receive a delayed intervention
The study design is a randomized controlled trial with delayed intervention in the control hospital Because the intervention is an educational and organizational change directed at all PICU clinicians the unit of randomization and analysis is the PICU During the start-up phase case report forms will be developed and a consensus meeting with all nurse and physician co-investigators will be conducted The purpose of this consensus meeting will be to review the Childrens Hospital Boston experience with the sedation algorithm and reach agreement on its application in the two PICUs System nuances may impact protocol implementation and will require group discussion and multidisciplinary problem solving
Study design includes baseline assessment of the organizational structure and comfort practices in both units The PICU randomized to early intervention will then undergo training followed by implementation a one-month respite and post-data collection to evaluate the sustainability of the practice change The PICU randomized to delayed intervention will start with pre-data collection then undergo training followed by implementation This design allows multiple comparisons specifically baseline to interventioncontrol pre and post comparisons in both units and sustainability in one unit
Training will be multifaceted and will include all clinicians physicians nurses clinical pharmacists and physicians-in-training involved in the sedation management of intubated mechanically-ventilated patients A multidisciplinary cooperative approach is necessary to assure compliance and successful implementation of protocols Training material will include discipline-specific lectures informal discussions video on sedation and opioid withdrawal scoring bedside booklets and physician order sheets The research team will develop the supporting materials Physician training will focus on sedation and opioid withdrawal scoring identifying the patients trajectory of illness collaborating with nursing in prescribing the daily sedation goal and completion of the standardized order template Nursing content will likewise focus on sedation and opioid withdrawal scoring trajectory analysis and collaboration but also will include practical support on the daily wake-up test and titration of sedatives Prior to the intervention phase all physicians physician-in-training unit-based clinical pharmacist charge nurses and full-time nursing staff will be required to document their understanding of the intervention by completion of a discipline-specific scenario-based self-assessment evaluation Respiratory therapists will also require refresher instruction on extubation readiness testing and general information about sedation assessment and sedation algorithm
During the implementation phase daily multidisciplinary rounds will include identification of the patients trajectory of illness and daily prescription of a sedation goal and b sedation parameters Nurses will titrate the comfort medications as prescribed and perform a daily wake up test in patients during their stable phase who are not awake During the implementation phase a member of the research team will round separately on each patient to monitor for study compliance and offer staff support and re-training as necessary This level of vigilance is necessary to identify aspects of the algorithm that are challenging to clinicians and accurate reporting of protocol deviations requires an evaluation of the context of decision-making This daily check will not continue in the early intervention arm when sustainability is evaluated During the implementation phase all sedation orders will be derived from standardized physician orders This order template will serve two purposes physician education and enhanced compliance with the algorithm
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