An Algorithmic Approach to Ventilator Withdrawal at the End of Life

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2022-07-31

Brief Summary

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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.

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Detailed Description

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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

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Critical Care Palliative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Stepped wedge cluster randomized trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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.

Study Groups

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Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type ACTIVE_COMPARATOR

Ventilator withdrawal algorithm

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No