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

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ClinicalTrials.gov Identifier: NCT01606852
Recruitment Status : Completed
First Posted : May 28, 2012
Last Update Posted : November 18, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Anxiety Drug: Dexmedetomidine Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients
Study Start Date : March 2013
Primary Completion Date : July 2014
Study Completion Date : July 2015

Arms and Interventions

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 Name: Administered via a Lifecare PCA Infusion System (Hospira)

Outcome Measures

Primary Outcome Measures :
  1. Aggregate sedative exposure during PCS use (up to 5 days). [ Time Frame: 5 days after enrollment ]
    Will use the sedation intensity score (SIS; described in Weinert C, Calvin A. Epidemiology of sedation for mechanically ventilated patients. Critical Care Medicine 2007;35:393-401) and a similar dose frequency score.

Secondary Outcome Measures :
  1. Visual Analogue scale for anxiety (0-100). [ Time Frame: daily for up to 5 days after enrollment ]
    VAS-A is a 100 mm vertical line anchored at 'not anxious at all' (0) to 'the most anxious I have ever been'(100). Subjects mark the scale in response ti the question "How are you feeling today?" The scale is discussed in: Cline ME, Herman J, Shaw ER, Morton RD. Standardization of the visual analogue scale. Nursing Research 1992;4(6):378-80 and Chlan L. Relationship between two anxiety instruments in patients receiving mechanical ventilatory support. Journal of Advanced Nursing 2004;48(5):493-9

  2. Delirium incidence [ Time Frame: Daily up to 5 days ]
    Will use the Confusion Assessment Method-ICU (CAM-ICU) daily to assess for delirium. (Ely E, Inouye S, Bernard G. Delirium in mechanically ventilated patients: Validity and reliability of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). JAMA. 2001;286(21):2703-10)

  3. Time to Initiation of Weaning [ Time Frame: 5 days ]
    Time to Initiation of Weaning. Time to initiation of spontaneous breathing trials (SBTs) is the period from intubation to when the subject begins standard pressure-support trials managed by the unit respiratory therapists.

  4. Duration of mechanical ventilatory support [ Time Frame: up to 30 days after enrollment ]
    Length of mechanical ventilatory support. This will be calculated using two different start times: First, from the time of intubation to clinician-ordered extubation, withdrawal of ventilatory support or death; and second, from the time of study enrollment to the same endpoint

  5. Length of ICU Stay [ Time Frame: up to 30 days after enrollment ]
    Two different ICU length-of-stay variables will be recorded in a similar manner as ventilatory support duration. First, from the time of ICU admission to ICU discharge or death and second, from the time of study enrollment to the same endpoint.

  6. Adverse events [ Time Frame: During 5 days of study protocol ]
    arterial hypotension, bradycardia, self-extubations, and protocol violations related to drug, pump or both.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606852

United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Nursing Research (NINR)
Hospira, now a wholly owned subsidiary of Pfizer
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01606852     History of Changes
Other Study ID Numbers: IND 111693
R21NR012795 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2012    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
mechanical ventilation
respiratory failure

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action