Trial Outcomes & Findings for Intraosseous Pressure Monitoring in Intensive Care Unit Patients (NCT NCT02059928)

NCT ID: NCT02059928

Last Updated: 2018-07-03

Results Overview

External cuff pressure readings were recorded every 15 minutes, and IO pressure data obtained via pressure transducer was recorded continuously for up to 12 hours. IO systolic, diastolic, and mean pressure (IO SBP, IO DBP, IO Mean) readings were summarized for the minute before and minute following an external cuff pressure reading. The ratios as a percentage of IO pressures to external cuff pressures (IO Systolic Blood Pressure / Cuff SBP; IO DBP / Cuff DBP; IO Mean / Cuff Mean) were calculated.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Up to 12 hour data collection period
• Results posted on: 2018-07-03

Participant Flow

Participant milestones

Measure	Intraosseous Device Placement Intraosseous device Intraosseous Device pressure measurement
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intraosseous Device Placement n=20 Participants Intraosseous device Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients
Age, Continuous	60 years n=20 Participants
Sex: Female, Male Female	16 Participants n=20 Participants
Sex: Female, Male Male	4 Participants n=20 Participants
Region of Enrollment United States	20 participants n=20 Participants

PRIMARY outcome

Timeframe: Up to 12 hour data collection period

Population: Inclusion criteria included: age ≥ 18 year old, presence of an IO placed by EMS or in the Emergency Department, and planned admission to the Medical or Surgical Intensive Care Unit. Patients were excluded if they had anticipated surgery within 12 hours of IO placement, ongoing infection at the placement site.

External cuff pressure readings were recorded every 15 minutes, and IO pressure data obtained via pressure transducer was recorded continuously for up to 12 hours. IO systolic, diastolic, and mean pressure (IO SBP, IO DBP, IO Mean) readings were summarized for the minute before and minute following an external cuff pressure reading. The ratios as a percentage of IO pressures to external cuff pressures (IO Systolic Blood Pressure / Cuff SBP; IO DBP / Cuff DBP; IO Mean / Cuff Mean) were calculated.

Outcome measures

Measure	Intraosseous Device Placement n=20 Participants Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients
Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure ratio as a percentage of IO DBP to cuff DBP	40.5 percentage of IO pressure to cuff pressu
Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure Ratio as a percentage of IO mean to cuff mean	40.1 percentage of IO pressure to cuff pressu
Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure ratio as a percentage of IO SBP to cuff SBP	34.5 percentage of IO pressure to cuff pressu

Adverse Events

Intraosseous Device Placement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ralph J Frascone

Health Partners

Phone: 6512545304

Email: ralph.j.frascone@healthpartners.com

Results disclosure agreements

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