An Algorithmic Approach to Ventilator Withdrawal at the End of Life

Not Applicable

Completed

• Conditions: Palliative Care; Critical Care
• Interventions: Procedure: Ventilator withdrawal algorithm

• Registration Number: NCT03121391
• Lead Sponsor: Wayne State University

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.

Study Timeline

• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2017-04-14
• Study Start: 2017-04-20
• Study First Posted: 2017-04-20
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-26
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention	Ventilator withdrawal algorithm	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

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, United States