Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients

NCT01606852 | Completed Phase 1 Results DMC

• 2 other identifiers: IND 111693R21NR012795
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure; Anxiety

Keywords

sedation; mechanical ventilation; anxiety; respiratory failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Adverse Events

  During 5 days of study protocol

Study Arms (2)

usual sedative practice

NO INTERVENTION

Subjects will have "usual care" sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration.

Patient controlled sedation

EXPERIMENTAL

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

Interventions

Dexmedetomidine DRUG

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.

Also known as: Administered via a Lifecare PCA Infusion System (Hospira)

Patient controlled sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Nursing Research (NINR): collaborator
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Respiratory Insufficiency

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Mental Disorders; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Craig Weinert MD
• Organization: University of Minnesota

weine006@umn.edu

612-624-0999

Study Officials

• Craig Weinert, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2012
• First Posted: May 28, 2012
• Study Start: March 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2015
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-02

Locations

US (1)