Clinical trial NCT00549809: Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial
Official title: Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Failure
Keywords: mechanical ventilation; respiratory failure
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2007-10-26
Enrollment: 70
Sex: ALL
Minimum age (years): 28
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: to compare intermittent mandatory ventilation (IMV) with synchronous intermittent mandatory ventilation associated with pressure support (SIMV/PS) related to duration of mechanical ventilation/weaning and length of stay in PICU (LS). Design: randomized clinical trial. Setting: Pediatric intensive care unit at a university-affiliated hospital.

Detailed description: Objectives: to compare intermittent mandatory ventilation (IMV) with synchronous intermittent mandatory ventilation associated with pressure support (SIMV/PS) related to duration of mechanical ventilation/weaning and length of stay in PICU (LS). Design: randomized clinical trial. Setting: Pediatric intensive care unit at a university-affiliated hospital. Patients: children between 28 days and 4 years old, admitted between 10/2002 and 06/2004, and receiving mechanical ventilation (MV) for more than 48 hours. Patients were randomly assigned into two groups: IMV (IMVG; n=35) and SIMV/PS (SIMVG; n=35). Children with acute respiratory distress syndrome and tracheostomy were excluded. Ventilation and oxygenation data were recorded at admission and beginning of weaning. Results: Groups were not statistically different for age, gender, MV indications, PRISM score, COMFORT scale, sedatives, and ventilation and oxygenation parameters. Median of MV duration was 5 days for both groups (p\>0.05). Also, there were no statistical differences for duration of weaning \[IMVG: 1 day (1 - 6) vs. SIMVG: 1 day (1 - 6); p\>0.05\] and LS \[IMVG: 8 days (2 - 22) vs. SIMVG: 6 days (3 - 20); p\>0.05\]. Conclusion: There was no statistically significant difference between IMV and SIMV/PS in these children related to MV and weaning duration, and PICU length of stay.

Eligibility criteria: Inclusion Criteria:

* Children aged between 28 days and four years, who were consecutively admitted to the PICU and required MV for more than 48h were included.

Exclusion Criteria:

* Children who had chronic respiratory failure, tracheostomy, those transferred from the hospital, or died were excluded as were patients with acute respiratory distress syndrome (ARDS).

Primary outcomes:
measure: duration of mechanical ventilation/weaning and length of stay in PICU
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Jose Roberto Fioretto
state: Sao Paulo
Study officials:
affiliation: UNESP - Botucatu Medical School
name: Jose R Fioretto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moraes MA, Bonatto RC, Carpi MF, Ricchetti SM, Padovani CR, Fioretto JR. Comparison between intermittent mandatory ventilation and synchronized intermittent mandatory ventilation with pressure support in children. J Pediatr (Rio J). 2009 Jan-Feb;85(1):15-20. doi: 10.2223/JPED.1849. Epub 2008 Nov 6. English, Portuguese.