Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients

NCT01606852

Last updated date
Study Location
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Respiratory Failure, Anxiety
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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Acute Respiratory Failure, AnxietyTesting the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients
NCT01606852
  1. Minneapolis, Minnesota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients
Official Title  ICMJE Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Respiratory Failure
  • Anxiety
Intervention  ICMJE 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)
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2018)
15
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2012)
40
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01606852
Other Study ID Numbers  ICMJE IND 111693
R21NR012795 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE
  • National Institute of Nursing Research (NINR)
  • Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Craig Weinert, MDUniversity of Minnesota
PRS Account University of Minnesota
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP