Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients (PCS)

Mechanical ventilation (MV) is the most frequently used life-support modality in intensive care units (ICUs). To reduce anxiety, stress and promote tolerance of MV, nurses frequently administer a variety of sedative medications to their patients based on subjective observations.

The investigators hypothesize that patient-controlled sedation, compared to clinician-directed sedation, will decrease sedative exposure while decreasing patient anxiety during the episode of mechanical ventilation.

Study Overview

• Status: Completed
• Conditions: Anxiety; Acute Respiratory Failure
• Intervention / Treatment: Drug: Dexmedetomidine

Detailed Description

A study to determine whether critically ill patients, during a substantial portion of their time on mechanical ventilation, can reduce anxiety symptoms better with PCS than their caregivers while reducing over-sedation, duration of mechanical ventilation and length of ICU stay will require hundreds of subjects enrolled on a multi-day protocol. However, patient-controlled sedation has been used in less than 20 patients and only for less than 24 hours. Therefore this study is designed to:

1. Establish the feasibility of subject recruitment and protocol adherence in a randomized pilot trial that compares patient-controlled sedation (PCS) using dexmedetomidine to usual sedation practice in mechanically ventilated patients. Feasibility will be defined by: a) number and proportion of patients or proxies who consent to enrollment, b) proportion of eligible subjects enrolled on Days 1,2,3,4 etc, of mechanical ventilation, c) number of days on protocol, up to five days, that subjects successfully use the PCS device, d) ability of ICU nurses to adjust the pump and adhere to the infusion rates of the PCS protocol.
2. Develop and refine the study protocol including: a) improving the proportion of patient daily assessments actually completed such as anxiety and delirium scales, b) develop a protocol to reliably determine when the subject is not able to self-manage their sedation due to weakness, confusion or severe illness; c) create rules for suspending PCS therapy and d) develop a post-ICU symptom interview.
3. Estimate effect sizes on key variables to inform the design of a future randomized trial to compare: a) sedative exposure, anxiety levels, and delirium occurrence between groups, b) adverse event rates and protocol violations related to the drug, pump or both; and c) duration of mechanical ventilation and ICU stay.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult intubated patients with respiratory failure expected to require mechanical ventilation for at least an additional 48 hours
• subjects have to have at least a 50% chance of being able to operate the PCS machine (i.e., adequate hand strength and cognition)

Exclusion Criteria:

• aggressive ventilatory support such as positive end expiratory pressure > 15 cm of water, prone ventilation, use of high-frequency oscillator ventilator
• hypotension requiring vasopressors (systolic blood pressure < 85 mmHg), second or third degree heart block or bradycardia (heart rate < 50 beats/min.)
• permanent condition preventing the use of push button device (e.g., paralysis)
• pregnancy or lactation
• acute hepatitis or liver failure
• general anesthesia 24 hours prior
• acute stroke or uncontrolled seizures
• acute MI
• severe cognition or communication problems (e.g., coma as main reason for intubation, deafness without signing literacy, dementia or severe delirium)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual sedative practice; Subjects will have "usual care" sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration.
Experimental: Patient controlled sedation; Subjects will be given the hand actuator connected to a Lifecare PCA Infusion System in the PCA + continuous mode with the syringe filled with 4 ucg/ml of dexmedetomidine. A loading dose (0.5 mcg/kg) will be given followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Bedside RNs will adjust the basal rate to a maximum of based on the number of bolus requests in the prior two hours. Subjects can also receive bolus supplemental sedative medications (benzodiazepines and/or opioids)if needed in the judgment of the patient-care nurse.	Drug: Dexmedetomidine; loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days.; Other Names: Administered via a Lifecare PCA Infusion System (Hospira)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aggregate Sedative Exposure During PCS Use (up to 5 Days).	Will use the sedation intensity score Scale is based on a score of 1 (full arousal) to 4 (no arousal)	5 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	arterial hypotension, bradycardia, self-extubations, and protocol violations related to drug, pump or both.	During 5 days of study protocol

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute of Nursing Research (NINR); Hospira, now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Craig Weinert, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 9, 2012
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimate): May 28, 2012

Study Record Updates

• Last Update Posted (Actual): March 13, 2018
• Last Update Submitted That Met QC Criteria: February 13, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: mechanical ventilation; anxiety; respiratory failure; sedation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: IND 111693; R21NR012795 (U.S. NIH Grant/Contract)