An Algorithmic Approach to Ventilator Withdrawal at the End of Life
1 other identifier
interventional
165
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2016
CompletedFirst Posted
Study publicly available on registry
April 20, 2017
CompletedStudy Start
First participant enrolled
April 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedNovember 29, 2022
November 1, 2022
5.3 years
October 4, 2016
November 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Patient respiratory comfort
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.
Change from baseline through repeated measures up to 8 hours
Study Arms (2)
Control
NO INTERVENTIONThe medical intensive care unit in four hospitals will comprise the clusters. All four clusters begin the study under the control condition. Ventilator withdrawal is conducted by the usual personnel in those units. Data is collected through observation of the process and the respiratory comfort of the enrolled patients. Each cluster is randomly selected to sequentially cross over to the intervention. The remaining clusters continue with usual care (control) until selected for crossover.
Intervention
ACTIVE COMPARATOREach cluster is randomly selected to sequentially crossover to the intervention. When crossed over to the intervention the assigned intensive care nurse conducts the ventilator withdrawal according to the algorithm. The algorithm is informed by an objective measure of patient respiratory comfort. Data is collected through observation of the process and the respiratory comfort of the enrolled patients.
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients undergoing ventilator withdrawal
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Detroit Receiving Hospital
Detroit, Michigan, 48201, United States
Harper University Hospital
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Ascension Providence Hospital
Southfield, Michigan, 48075, United States
Related Publications (1)
Campbell ML, Yarandi HN. Effectiveness of an Algorithmic Approach to Ventilator Withdrawal at the End of Life: A Stepped Wedge Cluster Randomized Trial. J Palliat Med. 2024 Feb;27(2):185-191. doi: 10.1089/jpm.2023.0128. Epub 2023 Aug 18.
PMID: 37594769DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 4, 2016
First Posted
April 20, 2017
Study Start
April 20, 2017
Primary Completion
July 31, 2022
Study Completion
July 31, 2022
Last Updated
November 29, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
The investigators will provide public access to the de-identified data files through two open repositories: Wayne State University's DigitalCommons (http://digitalcommons.wayne.edu/), which will provide perpetual access to the data, and the Inter-University Consortium for Political and Social Research's openICPSR (https://www.openicpsr.org/), which will provide access to the data for at least 10 years.