A Prospective, Randomized, Blinded Study of BIS Analysis in ICU Patients Requiring Neuromuscular Blocking Agents

ICU Patients Clinical Trial

Official title:

A Prospective, Randomized, Blinded Study of BIS Analysis in ICU Patients Requiring Neuromuscular Blocking Agents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714974
• Other study ID #: UU7643
• Status: Completed
• Phase: N/A
• First received: July 8, 2008
• Last updated: July 8, 2008
• Start date: February 2000
• Est. completion date: October 2007

Study information

• Verified date: July 2008
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomized, blinded study in which patients will be enrolled into either treated(BIS group) or untreated (non-BIS) group employing bispectral analysis to measure the level of sedation/analgesia in patients receiving neuromuscular blocking agents.

To collect pertinent data on critically ill patients while they are receiving NMBA's. In particular to correlate sedation/analgesic medication needs between a group whose medication use is determined by the values obtained by bispectral analysis to a group who will have medications delivered by the standard of care presently used in the intensive care unit in which they are being treated.

To document that patients who are monitored with bispectral analysis are able to achieve an appropriate level of consciousness in a shorter time and require less manipulation and amounts of sedative or analgesic medications than those who are not monitored.

Description:

This is a prospective, randomized and blinded study being done in order to help evaluate the level of consciousness with bispectral analysis (BIS) in ICU patients who are pharmacologically paralyzed with NMBAs (neuromuscular blockade agents) and to assess such things as the amount of time required to achieve the appropriate level of sedation/analgesia. Data will be collected and evaluated via this FDA approved equipment. The intent of this project is to evaluate this technology in those who are requiring "anesthesia" like states (use of NMBAs) for prolonged periods in the critically ill patient population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2007
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consented ICU patient, receiving neuromuscular blocking agents.

Exclusion Criteria:

• Unable to be consented

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ICU Patients

Intervention

Device:
• BIS
Sedation dosing based on BIS value, oer treating physician discretion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of sedation required.		During period of neuromuscular blockade use in ICU	No
Secondary	Time requiring neuromuscular blockade and mechanical ventilation.		Time in ICU	No