Respiration, Artificial
Conditions
Keywords
Invasive Mechanical Ventilation, Coordinated Spontaneous Awakening and Breathing Trials
Brief summary
The purpose of this trial is to evaluate if augmenting a usual audit and feedback implementation approach with telehealth-enabled support improves coordinated spontaneous awakening/breathing trials and patient outcomes for mechanically ventilated patients.
Detailed description
Sedation and analgesia are utilized with invasive mechanical ventilation (IMV) to improve patient comfort and synchrony with the mechanical ventilator. Prolonged sedation, however, may result in increased time on IMV and increased risk for ventilator associated pneumonia, delirium, and poor long-term cognitive outcomes. Daily interruptions in sedation \[spontaneous awakening trials (SAT)\] coordinated with daily spontaneous breathing trials (SBT) reduce mortality, increase ventilator free days, decrease intensive care unit (ICU) length of stay, and reduces ventilator-associated events. Coordination of spontaneous awakening and breathing trials (C-SAT/SBT), however, are underutilized due to significant barriers to implementation and adherence. This cluster-randomized hybrid implementation/effectiveness trial will compare C-SAT/SBT adherence and clinical outcomes in the presence of traditional audit and feedback implementation strategies alone or augmented with a novel Telehealth-Enabled, real-time Audit and feedback for Clinician adHerence (TEACH) implementation strategy.
Interventions
OTHERTelehealth- enabled support for SAT/SBT adherence
Telehealth-enabled support over and above usual audit and feedback includes identifying candidates for spontaneous awakening and breathing trials, prompting bedside providers and guiding execution of the coordinated spontaneous awakening and breathing trials as needed.
OTHERUsual audit and feedback for SAT/SBT adherence
Usual audit and feedback
Sponsors
University of Utah
National Heart, Lung, and Blood Institute (NHLBI)
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient age \>=16 years admitted to study hospital ICU * Intubated and mechanically ventilated
Exclusion criteria
* Patient with pre-existing brain death admitted to study hospital for organ donation * Died within 24 hours of intubation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to C-SAT/SBT | intubation to extubation - an average of 5 days | Fraction of eligible days on which coordinated spontaneous awakening trial and spontaneous breathing trial completed. |
| Ventilator-free days to day 28 | 28 days | ventilator-free days to day 28 |
Secondary
| Measure | Time frame |
|---|---|
| 90-day Mortality | 90 Days |
| New ventilator-associated pneumonia | Through hospital discharge, an average of 10 days |
| 30-day Mortality | 30 days |
| Reintubation | intubation to extubation - an average of 5 days |
| Unintentional Extubation | intubation to extubation - an average of 5 days |
| ICU Length of Stay | Through hospital discharge, an average of 10 days |
| Hospital Length of Stay | Through hospital discharge, an average of 10 days |
Countries
United States
Contacts
Primary ContactCarlos Barbagelata
Backup ContactColin Grissom, MD
Outcome results
None listed