Critical Care, Palliative Care
Conditions
Brief summary
The proposed study is an important, under-investigated area of ICU care for terminally ill patients undergoing terminal ventilator withdrawal. The proposed research has relevance to public health because an algorithmic approach to the ventilator withdrawal process will enhance clinicians' ability to conduct the process while assuring patient comfort, using opioids and/or benzodiazepines effectively.
Detailed description
Terminal ventilator withdrawal is a process that entails the cessation of mechanical ventilatory support with patients who are unable to sustain spontaneous breathing and is commonly performed in the ICU. Ventilator withdrawal is undertaken to allow a natural death. Opioids and/or benzodiazepines are administered before, during, and after as an integral component of the ventilator withdrawal process to prevent or relieve respiratory distress, but there are few guidelines to determine how much to administer or when. Insufficient opioid and/or benzodiazepine administration places the patient at risk for unrelieved respiratory distress and preventable suffering. Conversely, excessive medication administration may hasten death, an unintended consequence, and one that concerns clinicians. The effective doses of medications given during ventilator withdrawal are unknown. The investigators hypothesize that an algorithmic approach to ventilator withdrawal, relying on a biobehavioral instrument to measure and trend distress, will ensure patient comfort, and guide effective opioid and/or benzodiazepine administration. The investigators plan to use a stepped wedge cluster randomized controlled trial with all clusters providing unstructured usual care until each cluster is randomized to implement the algorithmic approach (intervention). The proposed study is innovative because there is no standardized, evidence-based approach guided by an objective measure of respiratory distress to this common ICU procedure. The study has broad clinical significance to provide knowledge that can potentially reduce patient suffering.
Interventions
PROCEDUREVentilator withdrawal algorithm
Steps and decision trees in the algorithm include in descending order: Ascertain patient consciousness, perform cuff-leak test, evaluate for indications for pre-medication, select a withdrawal method, assess for respiratory distress with Respiratory Distress Observation Scale, medicate for respiratory distress with morphine, make an extubation decision, ascertain need for continuous morphine, ascertain need for supplemental oxygen, assess for post-extubation stridor, treat post-extubation stridor
Sponsors
National Institute of Nursing Research (NINR)
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
All study sites begin in usual care and each site is randomly assigned to crossover to the intervention arm until all sites conclude in the intervention arm.
Intervention model description
Stepped wedge cluster randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing ventilator withdrawal
Exclusion criteria
* Patients who are conscious and cognitively intact * Patients who will undergo organ donation after ventilator withdrawal * Patients who are brain dead * Patients with bulbar amyotrophic lateral sclerosis * Patients with C-1 to C-4 quadriplegia * Patients with locked-in syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient respiratory comfort | Change from baseline through repeated measures up to 8 hours | Respiratory comfort will be measured with the Respiratory Distress Observation Scale at baseline, at every ventilator change, after the ventilator is turned off, every 15-minutes for 2 hours after the ventilator is turned off. |
Countries
United States
Outcome results
None listed