Trial Outcomes & Findings for Ultrasound Guided Vascular Access in Pediatric Intensive Care Patients (NCT NCT00207883)

Results Overview

Success was defined as central venous catheter being able to thread into the vessel over the guide wire.

Recruitment status

COMPLETED

Target enrollment

212 participants

Primary outcome timeframe

immediate

Results posted on

2017-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 - Traditional Anatomic Landmark- LM traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique	Group 2 - Ultra Sound US ultra sound assisted CVC placement
Overall Study STARTED	93	119
Overall Study COMPLETED	93	119
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound Guided Vascular Access in Pediatric Intensive Care Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 - LM n=93 Participants traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique	Group 2 - US n=119 Participants ultra sound assisted CVC placement	Total n=212 Participants Total of all reporting groups
Age, Categorical <=18 years	93 Participants n=5 Participants	119 Participants n=7 Participants	212 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Patients for whom gender was recorded	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: immediate

Population: Population consisted of critically ill children requiring placement of a central venous catheter.

Success was defined as central venous catheter being able to thread into the vessel over the guide wire.

Outcome measures

Outcome measures
Measure	Group 1 - LM n=93 Participants traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique	Group 2 - US n=119 Participants ultra sound assisted CVC placement
Central Line Placement Success	82 participants	108 participants

SECONDARY outcome

Timeframe: immediate

Population: Critically ill children requiring central venous access.

Time, in seconds, till successful guide wire placement was achieved.

Outcome measures

Outcome measures
Measure	Group 1 - LM n=93 Participants traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique	Group 2 - US n=119 Participants ultra sound assisted CVC placement
Time to Successful Central Line Placement	269 seconds Interval 75.0 to 900.0	150 seconds Interval 76.5 to 435.0

Adverse Events

Group 1 - LM

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Group 2 - US

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group 1 - LM n=93 participants at risk traditional anatomic landmark central line placement utilizing palpation and the Seldinger technique. 18/93 (19.4%) had arterial puncture. None was considered serious.	Group 2 - US n=119 participants at risk ultra sound assisted central line placement 10/118 (8.5%) had arterial puncture. None was considered serious.
Blood and lymphatic system disorders arterial puncture	19.4% 18/93 • Number of events 18	8.4% 10/119 • Number of events 10

Additional Information

Jana Stockwell, MD

Children's Healthcare of Atlanta / Emory University

Phone: 404-785-1600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place