Related Experiment Video
Updated: Oct 28, 2025

Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies
Published on: January 16, 2019
ICU-free days as a more sensitive primary outcome for clinical trials in critically ill pediatric patients
Hanjin Cho1, Barbara Wendelberger2, Marianne Gausche-Hill3,4,5,6
1Department of Emergency Medicine College of Medicine Korea University Seoul Korea.
Insights
Intensive care unit (ICU)-free days offer a sensitive measure for pediatric prehospital care outcomes, potentially surpassing survival or neurological status alone. This metric captures both survival and functional recovery, aiding emergency medical services research.
Area of Science:
- Pediatric Emergency Medicine
- Critical Care Research
- Prehospital Care Outcomes
Background:
- Assessing intensive care unit (ICU)-free days in pediatric prehospital care.
- Evaluating ICU-free days as a sensitive outcome measure for emergency medical services (EMS) research.
Purpose of the Study:
- To determine the association between ICU-free days and patient outcomes in pediatric prehospital care.
- To compare the sensitivity of ICU-free days against traditional outcomes like survival and neurological status.
Main Methods:
- Utilized data from a prior pediatric prehospital trial comparing bag-valve-mask-ventilation (BVM) and endotracheal intubation (ETI).
- Defined ICU-free days as 30 minus ICU days (0-30 range), with death within 30 days assigned 0 ICU-free days.
- Compared ICU-free days between BVM and ETI groups and correlated with survival and Pediatric Cerebral Performance Category (PCPC) scores.
Main Results:
- No significant difference in median ICU-free days between BVM and ETI groups (0 vs. 0 days).
- BVM group showed greater ICU-free days in subgroups: foreign body aspiration (30 vs. 0 days), child maltreatment (0 vs. 0 days), and respiratory arrest (25 vs. 7.5 days).
- Higher ICU-free days correlated with increased survival to hospital discharge and favorable PCPC scores.
Conclusions:
- ICU-free days appear to be a valuable clinical endpoint in pediatric prehospital resuscitation.
- This metric may offer greater sensitivity than mortality or PCPC alone, encompassing aspects of both.
Background:
Our objective was to assess the association between intensive care unit (ICU)-free days and patient outcomes in pediatric prehospital care and to evaluate whether ICU-free days is a more sensitive outcome measure for emergency medical services research in this population.
Methods:
This study used data from a previous pediatric prehospital trial. The original study enrolled patients ≤12 years of age and compared bag-valve-mask-ventilation (BVM) versus endotracheal intubation (ETI) during prehospital resuscitation. For the current study, we defined ICU-free days as 30 minus the number of days in the ICU (range, 0-30 days) and assigned 0 ICU-free days for death within 30 days. We compared ICU-free days between the original study treatment groups (BVM vs ETI) and with the original trial outcomes of survival to hospital discharge and Pediatric Cerebral Performance Category (PCPC).
Results:
Median ICU-free days for the BVM group (n = 404) versus ETI group (n = 416) was not statistically different: 0 ICU-free days (interquartile range, 0-10) versus 0 (0-0), P = 0.219. Median ICU-free days were greater for BVM group in 3 subgroups: foreign body aspiration 30 (0-30) versus 0 (0-21), P = 0.028; child maltreatment 0 (0-14.2) versus 0 (0-0), P = 0.004; and respiratory arrest 25 (1-29) versus 7.5 (0-27.7), P = 0.015. In the original trial, neither survival nor PCPC demonstrated differences in all 3 subgroups-survival was greater with BVM for child maltreatment and respiratory arrest and favorable PCPC was greater with BVM for foreign body aspiration. Overall, in the current study, patients with more ICU-free days also had greater survival to hospital discharge and more favorable PCPC scores.
Conclusions:
This initial study of the association between ICU-free days and patient outcomes during prehospital pediatric resuscitation appears to support the use of ICU-free days as a clinical endpoint in this population. ICU-free days may be more sensitive than either mortality or PCPC alone while capturing aspects of both measures.
More Related Videos
06:04Objective Nociceptive Assessment in Ventilated ICU Patients: A Feasibility Study Using Pupillometry and the Nociceptive Flexion Reflex
Published on: July 4, 2018
11:27A Modified Sonographic Algorithm for Image Acquisition in Life-Threatening Emergencies in the Critically Ill Newborn
Published on: April 7, 2023
Related Concept Videos
Pharmacokinetics in Pediatric Patients: Drug Excretion
Acute Kidney Injury IV: Diagnostic Studies and Prevention
Drug Dosing: Infants and Children
Clinical Trials: Overview
Clinical Trials
There are four phases in a clinical trial. A phase one...
Acute Respiratory Failure-II
The underlying physiological abnormalities that contribute to hypoxemic respiratory failure include: