An Algorithmic Approach to Ventilator Withdrawal at the End of Life

Palliative Care Clinical Trial

Official title:

An Algorithmic Approach to Ventilator Withdrawal at the End of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121391
• Other study ID #: R01NR015768
• Secondary ID: R01NR015768
• Status: Completed
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: July 31, 2022

Study information

• Verified date: November 2022
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 process while assuring patient comfort, using opioids and/or benzodiazepines effectively.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Care
• Death
• Palliative Care

Intervention

Procedure:
• Ventilator 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

Locations

Country	Name	City	State
United States	Detroit Receiving Hospital	Detroit	Michigan
United States	Harper University Hospital	Detroit	Michigan
United States	Henry Ford Health System	Detroit	Michigan
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Ascension Providence Hospital	Southfield	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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