Trial Outcomes & Findings for Temperature Control in Central Fever in the Neuro-ICU (NCT NCT00751634)

NCT ID: NCT00751634

Last Updated: 2013-05-06

Results Overview

Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: baseline, one, two and six hours after application.
• Results posted on: 2013-05-06

Participant Flow

Participant milestones

Measure	Treatment Group Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Temperature Control in Central Fever in the Neuro-ICU

Baseline characteristics by cohort

Measure	Treatment Group n=20 Participants Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
Age Continuous	54.3 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, one, two and six hours after application.

Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol.

Outcome measures

Measure	Treatment Group at 0, 1, 2, 6 Hours n=20 Participants Application of the Gaymar Rapr-Round device per approved use
Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care 0 hours	100.8 degrees F Standard Deviation 0.4
Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care 1 hour	100.3 degrees F Standard Deviation 0.9
Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care 2 hours	99.9 degrees F Standard Deviation 1.1
Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care 6 hours	99.5 degrees F Standard Deviation 0.7

SECONDARY outcome

Timeframe: Six hours

For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was <100.4F

Outcome measures

Measure	Treatment Group at 0, 1, 2, 6 Hours n=20 Participants Application of the Gaymar Rapr-Round device per approved use
Time From Start of Cooling Device to Core Temperature < 100.4F	2.1 hours Standard Deviation 1.6

SECONDARY outcome

Timeframe: six hours

Population: All participants were analyzed for the outcome of BSAS=3

Severe shivering as measured by the bedside shivering assessment scale: 0 None: no shivering noted on palpation of the masseter, neck, or chest wall

1. Mild: shivering localized to the neck and/or thorax only

2. Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax)

3. Severe: shivering involves gross movements of the trunk and upper and lower extremities

Outcome measures

Measure	Treatment Group at 0, 1, 2, 6 Hours n=20 Participants Application of the Gaymar Rapr-Round device per approved use
Number of Participants With Severe Shivering	4 participants

SECONDARY outcome

Timeframe: six hours

New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period

Outcome measures

Measure	Treatment Group at 0, 1, 2, 6 Hours n=20 Participants Application of the Gaymar Rapr-Round device per approved use
Number of Participants With Hypotension	0 participants

SECONDARY outcome

Timeframe: Six hours

New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm

Outcome measures

Measure	Treatment Group at 0, 1, 2, 6 Hours n=20 Participants Application of the Gaymar Rapr-Round device per approved use
Number of Participants With Arrhythmia	0 participants

Adverse Events

Treatment Group

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Group n=20 participants at risk Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
Nervous system disorders Shivering	20.0% 4/20 • Number of events 4

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrew Naidech

Northwestern University

Phone: 312-503-3335

Email: a-naidech@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60