Critical CareNCT03121391
An Algorithmic Approach to Ventilator Withdrawal at the End of Life
A study testing Ventilator withdrawal algorithm in people with Critical Care and Palliative Care, run by Wayne State University at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Palliative Care
- What is being tested?
- Ventilator withdrawal algorithm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Apr 2017to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing ventilator withdrawal
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Detroit Receiving Hospital
Detroit, Michigan, 48201
Harper University Hospital
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
William Beaumont Hospital
Royal Oak, Michigan, 48073
Ascension Providence Hospital
Southfield, Michigan, 48075
About this study
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.
Read the 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.
- Conditions
- Critical Care, Palliative Care
- Being tested
- Ventilator withdrawal algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilator withdrawal algorithmProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The 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 comparator | Each 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. Receives: Procedure: Ventilator withdrawal algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline through repeated measures up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start20 Apr 2017
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Margaret Campbell, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121391
- Sponsor's protocol ID
- R01NR015768
- Other IDs
- R01NR015768
- Status last verified
- Nov 2022
- First submitted
- 4 Oct 2016
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37594769
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Algorithmic Approach to Ventilator Withdrawal at the End of Life
- ClinicalTrials.gov ID
- NCT03121391
- Acronym / sponsor ID
- R01NR015768
- Conditions
- Critical Care, Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The 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 comparator | Procedure: Ventilator withdrawal algorithmEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing ventilator withdrawal
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilator withdrawal algorithmSteps 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 | Procedure or surgery | Intervention |
Primary outcome
Patient respiratory comfort
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Derived from this study: PubMed 37594769Campbell 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilator withdrawal algorithm in people with Critical Care and Palliative Care, run by Wayne State University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient respiratory comfort (time frame: Change from baseline through repeated measures up to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03121391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.