Phase 2 Completed N=15 Randomized Treatment

Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients

Respiratory Failure · Anxiety

Source: ClinicalTrials.gov NCT01606852 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcomePrimary: Aggregate Sedative Exposure During PCS Use (up to 5 Days). — 4; 3.5 units on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Aggregate Sedative Exposure During PCS Use (up to 5 Days).	4; 3.5	—
SECONDARY Number of Participants With Adverse Events	7; 8	—

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01606852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.